Safetv Issues When Using a 16% Carbaniide

Peroxide Whitening Solution

ABSTRACT

Background: The scientific literature is lacking on the occurrence of side effects and other safety
issues when using carbamide peroxide whitening solutions of concentrations greater than 10%.
This double-blind nightguard vital bleaching study compares safety issues when using 16% carbamide peroxide against a placebo or 10% carbamide peroxide (Nite White Classic by Discus
Dental Inc.). Evaluated were changes in gingival index, plaque index, nonmarginal gingival
index, nongingival oral mucosal index, tooth vitality, and the patients' perceptions of tooth sensitivity and gingival irritation.
Materials and Methods: Twenty female dental hygiene students participated in the study. Each
participant wore a maxillary treatment tray for 1 week without any solution and then for 8 to 10
hours per night for 14 nights, filling each quadrant with placebo, 10% carbamide peroxide, or
16% carbamide peroxide, using a split tray design.
Results: With respect to gingival index, plaque index, nonmarginal gingival index, nongingival
oral mucosa index, tooth vitality, and tooth sensitivity, there were no statistically significant
differences between the 16% carbamide peroxide solution and the other two solutions ( p > .05).
Quadrants receiving the 16% carbamide peroxide solution experienced more gingival irritation
than quadrants receiving placebo or 10% carbamide peroxide solution ( p > .05).
Conclusions: When evaluating the above-mentioned safety issues, except for gingival irritation,
there were n o statistically significant differences between a 16% carbamide peroxide solution
and 10% carbamide peroxide solution or a placebo when used as described here.
CIJNICAL SIGNIFICANCE

Among the 20 participants whose data were analyzed, it was found that a 16% carbamide peroxide whitening solution (Nite White Classic), when used as described in this study, can be effective in nightguard vital bleaching with n o statistical differences in gingival index, plaque index,
nonmarginal gingival index, nongingival oral mucosa changes, tooth vitality, or tooth sensitivity,
compared with a 10% whitening solution (Nite White Classic). More gingival irritation was
experienced with 16% carbamide peroxide. Additionally, 20% of the participants in this study
self-reported sensitivity when wearing their treatment tray without any solution, and 36% of the
participants reported sensitivity to the placebo solution.
Esthet Restor Dent 14:358-367, 2002)

* [ ; h i c u l Associate Professor, L)epartmertt o f Diagnostic Scierzces atxd General Dentistry, UniLwrsity o f

North Carolina .School of Dentistry, Chapel Hill, North Carolina
C/I?iica/Assistant Professor, Lh?partnrent of Diagttostic Sciences and General Dentistry. UtrIversity of
North Carolim . ~ C h o O /of Dentistry, Chapel Hill, North C~aro/irza
t Professor. Department o f Dlagtxostlc Sciences and Geizeral Dentistry, U m w s i t y o f North (;arol:tza School
of h!ntistry, Chapel Hill, North Carolirza
~Assista,itI'rofessor, I)eparimenr of Ilerztal Ecoloigy, Uuiversity (if North Carolina S c h < ~ <oi lf Iletrtistry,
Chapel Hill, North Carolina
3.58

J O l J K N t \ l . O t E S T H E T I C : AN11 R E S T O R A T I V E I 1 F . N T I S T R Y

LEONARD ET AL

ightguard vital bleaching

(NGVB) has gained acceptance among dentists and patients
as a simple, effective, and safe
procedure to lighten discolored
Since its introduction by
Haywood and Heymann in 1989,
tooth whitening has become one of
the most popular esthetic procedures
offered by dentists and requested by
patient^.^ The original technique
involved the application of a 1 0 %
carbamide peroxide (CP) solution
as the active whitening agent. Many
modifications, improvements, and
variations in the clinical technique
have occurred over the past 11
years.4~9~21-25
One of the changes
includes the use of CP in concentrations greater than 10%. Some
clinicians and manufacturers claim
that higher-concentration CP
whitening solutions are more effective and quicker in obtaining an
esthetically pleasing result than
10% CP solutions.
Currently, whitening solutions of
12 to 30% CP exist on the market
for at-home whitening. With the
higher-concentrated CP solutions,
one should be concerned about the
possibility of increased side effects,
such as tooth sensitivity to thermal
changes and gingival irritation.
This might be especially true for the
more viscous whitening solutions
designed for overnight use.
Few data exist in the literature with
respect to safety issues and CP
whitening solutions greater than
10%. Only two peer-reviewed in

vivo NGVB studies have been

reported comparing 1 0 % CP
whitening solutions with higher
CP concentration^.^^>^^ In addition
to reporting on tooth shade changes
occurring during treatment between
the two CP solutions, both studies
reported on the occurrence of tooth
sensitivity, but only one study
reported on gingival irritation as
perceived by the patient. Neither
study reported on safety issues, such
as gingival inflammation, plaque
buildup, nonmarginal gingival
damage, nongingival oral mucosal
damage, and tooth vitality. At the
present time, only 10% CP solutions
have received the American Dental
Association seal of acceptance as
being safe and effective peroxidecontaining whitening solutions.
Dentists prescribing whitening solutions of CP concentrations greater
than 1 0 % do so at their own professional risk with few safety data
to back them up. In a lawsuit in
which a patient alleges an adverse
outcome, which may not be related
to the whitening, the literature provides little defense for the use of
higher-concentrated CP. Therefore,
with the lack of information in the
literature on CP whitening solutions higher than l o % , the purpose
of this double-blind NGVB study
was to compare safety and patient
comfort issues when using a 1 6 %
CP whitening solution with using a
placebo or a 1 0 % CP solution.
MATERIALS AND METHODS

Twenty female dental hygiene

students were enrolled into this

randomized clinical trial. Each

participant completed a consent
form approved by the University of
North Carolina School of Dentistry
Institutional Review Board and a
health history form and received an
oral examination prior to beginning
the study. Maxillary alginate
impressions were taken, stone models generated, and scalloped maxillary treatment trays fabricated from
0.04" tray material (Discus Dental
Inc., Culver City, California). The
tray was trimmed just short of the
facial and lingual gingival margin
so as not to infringe on the gingival
soft tissue. Facial reservoirs were
used on the maxillary right second
premolar to the lateral incisor and
on the maxillary left lateral incisor
to the second premolar on each
stone model. Three treatment solutions were used in the study: 16%
CP (Nite White@Classic 16%), 10%
CP (Nite White@Classic l o % ) , and
a placebo (P) (Nite White@Classic
without CP), all supplied by Discus
Dental Inc. Nite White Classic 10%
is an approved ADA peroxidecontaining oral hygiene product.
Treatments were assigned to maxillary quadrants using block randomization. The six possible treatment
combinations (PIP, P/10, P/16,
10/10, 10/16, 16/16) were distributed among the first six participants
in random order, then among the
second six participants in random
order, and so on until all 20 participants had been assigned to treatments. The final distribution was
such that of the 20 right maxillary

V O L U M E 14, N U M B E R 6 , 2 0 0 2

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SAFETY I S S U E S WHEN USING A 1 6 % CARBAMIDE PEROXIDE WIII'I'ENING S O L U T I O N

quadrants, 6 were assigned the

placebo and 7 were assigned 10%
CP and 16% CP solutions, respectively. Of the 20 left maxillary quadrants, 8 were assigned the placebo,
7 were assigned 10% CP, and 6
were assigned the 16% CP solution.
Participants were instructed to place
the treatment solution in the specified quadrant from the maxillary
right second premolar to the lateral
incisor and the maxillary left lateral
incisor to the second premolar. This
instruction was intended to allow
each quadrant under study to be
isolated from its adjacent quadrant.
In addition, participants were
instructed to wear their trays 8 to
10 hours per night for 14 nights.
Participants were asked to follow a
standard oral hygiene regimen and
to refrain from smoking and the

consumption of red wine, coffee,

tea, and other staining food and
drink throughout the study.
Objective outcomes evaluated were
the changes in gingival index (GI),
plaque index (PI), nonmarginal gingival index (NMGI),nongingival
oral mucosal index (NGOMI), and
tooth vitality (TV).
To assess the gingival conditions of
each participant, the Loe-Silness
GI was employed (Table
Each quadrant was isolated with
cotton rolls, air dried, and visibly
and tactically inspected using a
mouth mirror and probe. Four gingival areas (distal, facial, mesial,
lingual) were examined systematically for each tooth. Plaque accumulations were scored using the

PI method of Loe-Silness. The PI

was carried out in a similar manner as the GI. To evaluate soft tissue changes occurring in the oral
cavity (ulcers, abrasion, etc.), the
nonmarginal gingival index and
nongingival oral mucosa index
were used, as developed and
described by Curtis and colleagues
(see Table 1).2Examiners completed calibration sessions on GI,
PI, NMGI, and NGOMI prior to
beginning the study.

l).2926>27

Tooth vitality was' assessed using

coolant-saturated (Hygenic Green
Endo Ice@,The Hygenic Corporation, Akron, Ohio) cotton tip
applicators applied to the facial
surfaces of the maxillary left and
right first premolars and lateral
incisors. A response to the coolant

TABLE 1. RANKING SCALES OF CLINICAL M E A S U R E M E N T S .

Plaque Index

Gingival Index

Nonmarginar Gingival Index and

Nongingival Oral Mucosal Index

No plaque in the gingival area

Normal gingiva

N o evidence ot abnormality

A film of plaque adhering to the

free gingival margin and adjacent area
of the tooth, recognizable only by
running a probe across the tooth surface

Mild inflammation
Slight change in color
Slight edema
No bleeding on probing

Erythema present
No evidence of ulceration

,Moderate accumulation of plaque

within the gingival margin and/or on
the adjacent tooth surface that can be
seen by the naked eye

Moderate inflammation
Redness
Edema
Glazing
Bleeding on probing

Mild ulceration
Minimal loss of epithelial
integrity

Abundance of plaque within the

gingival pocket or on the gingival
margin and adjacent tooth surface

Severe inflammation
Marked redness
Edema
Glazing
Ulceration
Tendency to bleed spontaneously

Frank ulceration
Significant loss of epithelial
integrity or tissue sloughing

Ranking

Copyright 0 1996 American Dental Association. Reprinted by permission of ADA Publishing Co. a Division of ADA Business Enterprises, inc.
from Curtis JW, Dickinson CL, Downey MC, et al. Assessing the effects of 10 percent carbamide peroxide on oral soft tissues. J Am Dent Assoc
1996; 127:1220.

360

JOURNAL O F ESTHETIC A N D RESTORATIVE DENTISTRY

LEONARDETAL

within 10 seconds was recorded as

a positive response. If there was n o
response to the coolant within
10 seconds, then a negative response
was recorded. There was no attempt
made to quantify the response.
Participants were given a diary to
record their perceptions of tooth
sensitivity (TS) and gingival irritation (GIrr) and tooth shade change
during the study. Instructions were
also given to cease using the treatment solutions if TS o r GIrr was
perceived as too great to tolerate
continued application of solutions.
Once discomfort disappeared, participants were to resume application of treatment solutions.
Five clinical evaluations were conducted: baseline (insertion), 1 week
after wearing the tray with n o
treatment solution, after 1 week of
treatment, after 2 weeks of treatment, and I week post-treatment.

At the insertion appointment the

treatment tray was delivered and
adjusted intraorally according to
the guidelines prescribed by the
manufacturer. Baseline maxillary
GI and PI were determined a t this
appointment as well a s NMGI and
NGOMI. Tooth vitality of tooth
numbers 5 , 7, 10, and 12 was also
determined. Information about the
treatment process and written
instructions were given to each
participant, as well as a daily log
form to record enamel shade
changes, TS, GIrr, and other comments o r concerns.
Participants were evaluated after
wearing the guard alone for 1 week,
and after 7 and 14 days of treatment, to evaluate changes in GI,
PI, NMGI, NGOMI, TV, TS, and
GIrr and concerns of the participant.
Treatment was discontinued a t the
end of 14 treatment days, a t which
time the log forms were collected.

Participants were seen 1 week posttreatment to evaluate changes in

GI, PI, NMGI, NGOMI, TV, TS,
and GIrr and to complete a questionnaire on their perception of the
NGVB procedure (Table 2).
SUDAAN software, Release 7.1 1
(Research Triangle Institute,
Research Triangle Park, North
Carolina), was used for statistical
analyses that adjusted for the presence of multiple quadrants within
subjects.2xAfter frequency tables
were generated, cross-treatment
comparisons were performed using
chi-squared tests and Student's t-test.
RESULTS

Nineteen of the 20 participants

completed the study. The mean age
of the 20 participants was 23
(range, 20-30 yr). Average number
of days of treatment for participants completing the study was
1 3 and mean number of hours of

TABLE 2. PATIENTS' PERCEPTIONS OF NIGHTGUARD VITAL BLEACHING 1 WEEK POST-TREATMENT.*

No (%I

Question

1. Have you had any sensitivity with any of the teeth you treated since ending the treatment
process that may be treatment related?
2. Have you had any gingiva (gum) sensitivity since ending the treatment process that may be
treatment related?
3. Are you glad you went through this treatment process?
4. Would you go through this treatment process again?
5. Would you recommend this treatment procedure to a friend?
6. Do you feel that your teeth are lighter now than when you began the nightguard vital
bleaching procedure?
7. Do your teeth normally get sensitive after a tooth cleaning?
8. Are your mth normally.sensitive to hot and cold?

95

100

84
89
100

16

68
0
25

11

32
100

75

*n = 19.

V O L U M E 14, N U M B E R 6 , 2 0 0 2

361

S A F E T Y I S S U E S WHEN USING A 1 6 % CARBAMIDE P E R O X I D E WHITENING S O L U T I O N

treatment was 91 hours (range,

55-1 13 hr; average, 7 hr per treatment application). Five participants
(25%)presented with preexisting
hot or cold tooth sensitivity and
4 participants (20%) experienced
TS or GIrr while wearing the guard
alone for an average of 3.5 days.
One participant dropped out of the
study because of TS and GIrr after
5 nights of treatment, and one participant (5 YO)experienced TS and
GIrr beyond the 1-week posttreatment period.

baseline at any time point with

respect to GI, PI, NMGI, and
NGOMI ( p .05). One participant
presented' to the clinic during the
active treatment phase with cheek
biting, and two different participants presented with an ulcer on
their buccal mucosa, all determined
to be unrelated to the whitening
treatment. Clinically, more areas of
GIrr were reported in participants
using the 16% CP solution than in
those using the other two solutions
(Tables 3 and 4; Figure 1).

S A F E T Y ISSUES

T O O T H VITALITY

Gingival Index, Plaque Index,

Nonmarginal Gingival Index,
Nongingival Oral Mucosal Index
There were no statistically significant differences among the three
groups at baseline or change from

There were no statistically significant differences among the three

groups at baseline or change from
baseline at any time point (p > .05)
with respect to tooth vitality. At the
end of the study, one tooth (4%)in

the 16% group, two teeth (7.7%)

in the 10% CP group, and two
teeth (7.4%)in the placebo group
did not respond to the Endo Ice
that had responded positively at
baseline. The response to the TV
test was found to be within the reliability of the method a ~ p l i e d . ~ ~ > ~ O
P A T I E N T S ' P E R C E P T I O N S OF
TOOTH S E N S I T I V I T Y A N D
GINGIVAL IRRITATION

With respect to patient-perceived

TS, there were no statistically significant differences between the
numbers of quadrants reparted as
having TS with respect to any treatment solution at any time point or
for the number of days that TS was
reported. A statistically significant
difference did exist for GIrr caused
by the three treatment concentra-

TABLE 3. T O O T H S E N S I T I V I T Y A N D G I N G I V A L I R R I T A T I O N O U T C O M E BY T R E A T M E N T S O L U T I O N .

Treatment Solution

Number of quadrants
Total days of treatment for each solution reported by all participants
TS
Quadrants
Total days reported by all participants
First occurrence of TS
Average day of TS Occurrence
Average days of TS

14
183

12
159

2 (14%)
5 (3%)
1

5 (36%)
13 (7%)
1
5
<1

First occurrence of Girr

Average day of Girr occurretlce
Average days of GI

362

10% CP

3
<1

Girr
Quadrants
Total days reported by all participants

CP = cubiunide peroxide; TS = tooth semi-,

0% CP

Girr = &@Val

irritatiou.

JOURNAL O F ESTHETIC AND RESTORATIVE DENTISTRY

16% CP

12

156

3 (25%)
16 (10%)

4 (33%)
16 (10%)

6
5

8 (67%)
61 (38%)
3
4
8

11 (92%)
43 (28%)
3
4
4

L E O N A R D ET A L

tions. The quadrants receiving the

16% active solution experienced
more sensitivity ( p > .05) than did
the quadrants receiving the placebo
and 10% solution. Additionally,
quadrants receiving the active treatment solution (10Y0 and 16%)
experienced GIrr or TS for more
days ( p c .05) than did the quadrants receiving the placebo. Table 3
shows a comparison of the number
of quadrants experiencing TS and
GIrr symptoms in the three treatment groups. No quadrants were
reported as having experienced
TS only. Subjects in the Pff group
demonstrated somewhat better
compliance with the application
regimen, at 87% of recommended
application time used, than subjects
in either of the active treatment
groups, both of which had approximately 75% of the recommended
application time used. When adjusting for pretreatment thermal and
guard TS and GIrr, the same trends
were observed.
Questionnaire Results
One-week post-treatment, participants were given a questionnaire to
complete concerning their perceptions of the NGVB procedure.
Responses are presented in Table 2.
D ISC US S I O N

The primary purpose of this NGVB

whitening study was to evaluate
and compare safety issues, including TV and patients perceptions of
TS and GIrr of a 16% CP whitening solution, with those of a 10%

TABLE 4. M E A N SCORES OF ASSESSED CHARACTERISTICS BY TREATMENT

SOLUTION..

Baseline

7Days
Guard Only Tn.hnent

WDays
7 Days
Treatment Post-treatment

Carbamide
peroxide solution
0 Yo
10%
16%

0.0s

0.02
0.03

0.03
0.00
0.03

0.07
0.03
0.0s

0.01
0.0
0.03

0.0
0.0
0.0

0.03
0.01
0.01

0.00
0.00
0.00

0.00
0.00
0.00

0.00

0.0
0.0
0.0

0.0

0.0
0.0
0.0

0.0

0.0
0.0

0.0
0.0
0.0

0.0

0.0

Plaque index

0%
10%
16%
Nonmarginal
gingival index
0%

0.02
0.01

0.01

0.0

10%

0.0

16%

0.0

0.00
0.00

0.0
0.0

Nongingival
oral mucosa
0%

10%
16%

0.0
0.0

0.0

0.0
0.0

0.0
0.0

0.0

0.0

0.0

Not significant at p > .05.

CP solution and a placebo. All

solutions were highly viscous and
intended to be used overnight. It
was believed that this would represent the worst case scenario for
developing side effects during
NGVB. Results showed that a 16%
CP whitening solution, when used
as described in this study, can be
effective in NGVB, with no statistical difference in clinical safety
indices, TV, or TS, compared with
a 10% whitening solution or a
placebo. Clinically, however, participants receiving either of the active
solutions did record more quadrants experiencing TS and experienced TS for more total days than
those quadrants receiving the

placebo. Likewise, those receiving

the 16% CP solution reported more
quadrants experiencing sensitivity
than those receiving the 10% CP
solution. With respect to GIrr, the
quadrants receiving the 16% CP
solution experienced more GIrr
than did the quadrants receiving
the placebo or 10% CP solution. A
larger sample size may be required
for these nonsignificant results to
be more meaningful; nevertheless,
patients should be made aware of
information obtained from even
small research studies.
In previous studies TS or GIrr has
been reported in up to 67% of the
participants during NGVB with a

V O L U M E 14, N U M B E R 6 , 2 0 0 2

363

SAFETY ISSUES WHEN USING A 16% CARBAMIDE PEROXIDE WHITENING SOLUTION

mon desensitizers are potassium

nitrate and neutral sodium fluoride.
Potassium nitrate has been shown to
reduce sensitivity in patients who
have had periodontal surgery, when
applied in a bleaching-type tray.32
These desensitizers have also been
marketed as stand-alone products
that can be used during the treatment period if needed, primarily
for TS.
Figure 1 . Gingival irritation of papilla between the maxillary
left lateral incisor, canine, and first premolar assoczated with
1 6 % carbamide peroxide. The area was reddened and inflamed. The patient also reported gingival discomfort in the area.
Note no irritation of gingiva between the maxillary left and
right central incisors (no treatment solution) or the maxillary
right lateral and central incisors (0% carbamide peroxide).

10% CP solution and in up to onethird of the participants using a

p[acebo.&7>9719,2l,22,24,25,31 For the
most part, the sensitivity experienced
was mild to moderate and ceased
quickly post-treatment. Results in
the present study for the placebo
and 10% CP groups as well as the
disappearance of sensitivity posttreatment are consistent with previous studies. Tray type and design,
hours worn, duration of treatment,
patient sensitivities, use of thickening agents, and so on may play a
role in whether a patient experiences sensitivity during whitening.
The sensitivity experienced by participants in this study was similar
to that experienced in other studies
with the same type of guard
(scalloped and with facial reser-

364

Since TS, GIrr, and other side effects

are a major concern for patients,
as well as a deterrent to whitening,
manufacturers have addressed this
issue in several ways. Glycerinbased solutions, which can theoretically dehydrate the tooth causing
discomfort, have given way to
water-based formulations or formulations with added water. Less viscous hydrogen peroxide solutions
have been formulated that are
intended to be worn for shorter
periods of time, thus decreasing the
risk for side effects. Conditioners
and desensitizers have also been
added to whitening solutions to help
reduce side effects. The most com-

JOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY

Five of the participants presented

with preexisting sensitivity to hot
and cold. No attempt was made to
randomize for preexisting sensitivity. The treatment combinations
assigned to each were 10%/10%,
P/lO%, P/l6%, l6%/l6%, and
1O%/P. Two participants reported
TS or GIrr when wearing the guard
alone for 1 week. During treatment,
one participant (P/16%) reported
TS or GIrr and the other did not
(P/lO%). Of the remaining three
participants, all reported TS or GIrr
indifferent of the treatment combination they were assigned. Eighty
percent of the participants presenting with pretreatment sensitivity
experienced sensitivity during treatment. Pretreatment sensitivity may
be an indicator for who might
experience sensitivity during NGVB
treatment and is worthy of further
investigation.
Participants were asked to wear
their guard for 7 nights without
any treatment solution to see if the
guard alone would cause sensitivity.

LEONARD E T A L

Four of the participants (20%)

reported TS or GIrr during this
period. Two of the participants also
reported preexisting sensitivity to
hot and cold. On average, the four
participants reported 3.5 days of
sensitivity while wearing the guard
along beginning on either day 2 or
day 3. During treatment, three of
the four reported sensitivity. No
correlation could be made with
respect to concentration of solution
used. When seen at 7 days posttreatment, only one participant
reported sensitivity, who had
received the treatment combination
of Pl16%. The participant was
seen a week later, at which time
no sensitivity was reported.
One participant quit the study
because of thermal tooth sensitivity
after 5 nights of treatment. The
participant had been assigned the
10%/16% treatment combination.
At the 7-day evaluation appointment, the participant expressed a
desire not to continue the study and
did not turn in the log form. The
participant was informed that the
treatment regimen could be modified (e.g., treat every other night,
decrease number of hours of use)
but declined. Upon further questioning by the principal investigator, it was noted that thermal sensitivity occurred in both quadrants
and all sensitivity had subsided at
the 7-day evaluation. Additionally,
the participant reported lightening
of tooth shade. Since no log form

was returned by the participant,

relevant data were not included in
any of the statistical analyses.
As mentioned previously, 1 9 participants completed the study. With
respect to TS in the active groups,
7 of the 2 4 quadrants (29%) experienced TS. Three of the 7 quadrants
(43%) experienced TS after the first
night of use. The average day for
TS to develop was day 5 (range,
day 1-day 12),and it lasted 5 days
for the 1 0 % group and 4 days for
the 16% group. Gingival irritation
occurred in 19 of 24 quadrants
(79%) that received the active solution. Six of the 1 9 quadrants (32%)
experienced GIrr after the first
night of use. The average day for
GIrr to develop was day 4 (range,
day 1-day lo), and it lasted 8 days
in the 1 0 % group and 4 days in the
1 6 % group. Quadrants receiving
the placebo solution experienced
less than 1 day of TS or GIrr.
Although this study did not show a
statistically significant difference
between the 16% CP and the other
two treatment groups with respect
to TS, clinically, the quadrants
receiving the active solutions experienced more TS. In accordance
with this study, Kihn and colleagues
reported no statistical difference in
the incidence of TS but did report a
trend in the variability of TS with
higher-concentrated whitening solutions.22 Matis and co-workers also
reported no statistical difference

between a 1 0 % and 15% CP

whitening solution, but clinically
there was a trend toward more
TS with the higher-concentration
The 1 5 % CP solution
used in the Matis study contained
fluoride. The effect of the fluoride
in the treatment solution was not
addressed, and what effect the
fluoride played in preventing or
decreasing TS is unclear.
Participants in the present study
reported more GIrr in the quadrants using the 1 6 % CP than did
the participants in the study of
Matis et a1.24 It is unclear why this
happened. One reason could have
been the small study sample in the
present study. Another could have
been that participants were all students and fabricated their own
treatment trays. For many, it was
the first time they had taken alginate impressions and fabricated
models. Although all guards were
evaluated before the study, for
several participants additional
trimming of the tray during active
treatment stopped GIrr as well as
TS. With the additional trimming,
the tray was approximately 1.O to
1.5 mm short of the tissue.
Although the tray did not cover the
entire tooth, whitening of the teeth
beyond the border of the tray did
occur without causing a shade gradient. This result concurs with a
report by Oliver and Haywood in
another NGVB study.33 Other factors that could have caused the

VOLUME 14, NUMBER 6 , 2002

365

S A F E T Y I S S U E S WHEN USING A 16% CARBAMIDE P E R O X I D E W H I T E N I N G S O L U T I O N

increase in GIrr could be the participants and their sensitivity to the

various chemicals in the whitening
agents o r tray. Four participants
(21%) reported sensitivity when
wearing the guard alone. The participant population could also have
been a factor, since it has been
reported that females and participants under 40 years of age tend to
report more side effects than d o
males and participants over 40?
Participants were surveyed 1 week
post-treatment concerning tooth
shade changes, TS and GIrr, and
their perceptions of the procedure.
All participants who received an
active solution reported that their
teeth became lighter during the
study. Except for one participant,
no one reported TS and/or GIrr
past the 1-week post-treatment
phase. This concurs with other
studies in which a whitening solution stronger than 10% CP was
used..24 Overall, the participants
were positive about their NGVB
experience and would recommend
the procedure. Since the study participants were dental hygiene students and will be in an excellent
position to discuss tooth whitening
with their patients, many believed
the knowledge and experience
gained by actually having gone
through the NGVB procedure will
be invaluable to them in educating
their patients.

366

C O N C 1. US I 0 N

When evaluating changes in GI,

PI, NMGI, NGOMI, TV, and the
patients perceptions of TS and GIrr
in this relatively small sample size,
GIrr was the only characteristic
that showed significant differences
between a 16% CP solution and a
10% CP solution or a placebo solution, when used as described here.
However, a trend was seen clinically
in which the quadrants receiving
the 16% CP solution experienced
more TS and GIrr than did the
quadrants receiving the 10% CP
solution. The trend toward more
sensitivity with whitening solutions
greater than 10% is supported by
other s t u d i e ~ .Patients
~ ~ . ~ ~should
be made aware of this increase in
clinical sensitivity when using
whitening solution greater than 10%
CP. Additionally, regardless of the
material used, patients should be
informed that they may experience
sensitivity, since 36% of the placebo
quadrants experienced TS or GI and
20% of the participants reported
sensitivity when wearing the guard
alone. Participants were positive
about their whitening experience and
would recommend this procedure.
Further study is needed in this area
of tooth whitening when using CP
concentrations greater than 10%.
Additionally, research is needed on
how desensitizers, hydrogen peroxide, and less viscous whitening solutions influence TS and GIrr.

J O U R N A L OF E S T H E T I C A N D K E S T O R A T I V E D E N T I S T K Y

D I S C 1 O S l J K E ANI)

A C K N 0 W 1 E l ) ( ; M ENIS

Supported in part by Discus

Dental, Inc. The authors acknowledge Ms. Marsha Black for her
assistance with the clinical component of the study and Ms. Judy Dow
for her assistance in preparing the
manuscript.
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Presented in part at the Annual Session of the

International Association for Dental Research,
Vancouver, British Columbia, Canada,
March 10-13, 1999.
Reprint requests: Ralph H . Leonardlr.,
DDS, M P H , UNC School of Dentistry,
179 Dental Building, Chapel Hill,
North Carolina 27599.7450; e-mail:
Ralph-Leonard@dentistry.uric.edu
0 2 0 0 2 BC Decker lnc

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