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1 Orthodontic Department, Liverpool University Dental Hospital, Liverpool, UK. 2 Cochrane Oral Health Group, MANDEC, School
of Dentistry, The University of Manchester, Manchester, UK
Contact address: James E Cooper, Orthodontic Department, Liverpool University Dental Hospital, Pembroke Place, Liverpool, Mersey-
side, L3 5PS, UK. jamescooper@casualty.co.uk.
Citation: Cooper JE, Harrison JE, Worthington HV. Drug interventions for pain relief during orthodontic treatment. Cochrane
Database of Systematic Reviews 2003, Issue 1. Art. No.: CD003976. DOI: 10.1002/14651858.CD003976.
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
1) the effectiveness of drug interventions for pain relief during orthodontic treatment; and
2) whether there is a difference in the analgesic effect provided by different types, forms and doses of analgesia taken during orthodontic
treatment.
Pain during orthodontic treatment has been shown to be the most Criteria for considering studies for this review
common reason for patients wanting to discontinue treatment and
was ranked as the worst aspect of the treatment (Oliver 1985).
Patients who underwent both premolar extractions and orthodon-
Types of studies
tic tooth movement experienced more pain 24 hours after initial
arch wire placement than 24 hours after tooth extraction (Jones All randomised and quasi-randomised controlled clinical trials re-
1992). When separators (small rubber bands that make space for lating to analgesia during orthodontic treatment.
metal orthodontic band attachments around the back teeth) are
placed between the teeth the pain gradually increases and peaks
the day after placement and then decreases. By 7 days the pain Types of participants
levels have decreased to the same level as 2 hours following treat- Trials will be eligible for inclusion in the review if they have re-
ment (Bernhardt 2001). The amount of pain experienced depends cruited participants receiving any type of orthodontic treatment.
upon the type of tooth movement occurring (tipping or bodily All age groups will be considered.
movement) and especially the pain threshold of the individual. It Trials assessing pain relief following tooth extraction or surgical
is likely that patients only require drug assisted pain relief for 2 to interventions, that are associated with orthodontics, will not be
3 days out of every 4 to 6 weeks so the long term implications of included.
the drug treatment are probably small.
Pain relief in dentistry has been fairly well studied in the literature
Types of interventions
but the management of pain associated with orthodontic treat-
ment is less well known. As clinicians we are often asked whether it
will be necessary for patients to take pain killers during orthodon-
tic treatment and if so which is likely to be the most effective. Some Active interventions
studies have shown that pre-treatment doses of non-steroidal anti- Local anaesthetic, any NSAID, paracetamol, opioid analgesics
inflammatory drugs may help to reduce the amount of pain ex- taken by any route, in any
perienced immediately after treatment (Steen Law 2000). How- dose, form or combination at any time following treatment or up
ever, there is some uncertainty among orthodontists as to which to 2 hours before
painkillers are most suitable and whether pre-emptive analgesia is treatment.
beneficial.
Primary
Electronic searching
For the identification of studies included or considered for this re-
Patient reported pain intensity/pain relief measured on a visual
view detailed search strategies will be developed for each database
analogue scale and/or categorical scale.
searched. These will be based on the search strategy developed
Duration of pain.
for MEDLINE but revised appropriately for each database. The
search strategy will use a combination of controlled vocabulary
and freetext terms based on the search strategy for MEDLINE
Secondary (see Appendix 1), in conjunction with phases one and two of the
Cochrane sensitive search strategy for randomised controlled clin-
Dose and frequency of pain relief needed.
ical trials (RCTs) as published in the Cochrane Reviewers’ Hand-
Any rescue (alternative) pain relief taken/prescribed, including
book, Appendix 5c.
dose and time, following last treatment.
Adverse effects of painkillers e.g. total gastro-intestinal side effects.
Withdrawals from the study for any reason.
Failure to complete orthodontic treatment due to the pain expe- Databases to be searched
rienced. The following databases will be searched:
Visual analogue scales and any categorical outcomes will be trans- OHG Trials Register to current date;
formed into dichotomous data and analysed as such. Cochrane Pain, Palliative and Supportive Care Group Trials Reg-
ister to current date;
Cochrane Central Register of Controlled Trials (CENTRAL):
whole database at current issue;
Comparisons
MEDLINE 1966 - present;
1) Any analgesic at any dose taken at any time versus placebo at EMBASE 1980 - present;
any dose taken at any time. If there is evidence of effectiveness CINAHL 1982 - present.
further analysis of the class and type of drug will be undertaken;
2) Opioid of any type, at any dose taken at any time versus placebo
at any dose taken at any time; Handsearching
2.1) Subgroup analysis of type of opioid at any dose taken at any
time versus placebo at any dose taken at any time; A check will be made to see which journals have already been hand-
3) NSAID of any type, at any dose taken at any time versus placebo searched as part of the Oral Health Group’s handsearching pro-
at any dose taken at any time; gramme. The handsearching of the following journals will then be
3.1) Subgroup analysis of type of NSAID at any dose taken at any updated to the most current issue as appropriate: American Jour-
time versus placebo at any dose taken at any time; nal of Orthodontics and Dentofacial Orthopaedics; Angle Orthodon-
4) Paracetamol at any dose taken at any time versus placebo at any tist; European Journal of Orthodontics; Journal of Orthodontics; Aus-
dose taken at any time; tralian Journal of Orthodontics; Seminars in Orthodontics; Clinical
4.1) Subgroup analysis of type of paracetamol at any dose taken Orthodontics and Research.
at any time versus placebo at any dose taken at any time; If it appears, from searching the Cochrane Pain, Palliative and
5) Local anaesthetic at any dose given at any time versus placebo Supportive Care Group Trials Register, that relevant studies are
at any dose taken at any time; being found in non-orthodontic journals then these will be hand-
5.1) Subgroup analysis of type of local anaesthetic at any dose searched as necessary.
taken at any time versus placebo at any dose taken at any time. The bibliographies of the clinical trials identified will be checked
6) If there is evidence of effectiveness in any of the classes or for references to trials published outside the handsearched journals.
subgroups further analysis will be undertaken to determine the Personal references will be checked.
effectiveness and harms at different doses of opioid / NSAID /
paracetamol / local anaesthetic versus placebo.
7) Head to head comparisons of the best doses for each class and/ Language
or type of analgesic. Databases will be searched to include papers and abstracts pub-
8) Head to head comparisons of the best in each class and/or type lished in all languages and every effort will be made to translate
of analgesic. non-English papers.
Quality assessment
ACKNOWLEDGEMENTS
Two review authors (JC and JH) will undertake the quality assess-
ment of the included trials independently and in duplicate as part We would like to acknowledge the assistance of Sylvia Bickley (Tri-
of the data extraction process. Disagreements will be resolved by als Search Co-ordinator, Cochrane Oral Health Group) in devel-
discussion between JC and JH or the involvement of HW. oping the search strategy.
APPENDICES
WHAT’S NEW
HISTORY
Protocol first published: Issue 1, 2003
CONTRIBUTIONS OF AUTHORS
The review was conceived by Jayne Harrison (JH). James Cooper (JC) and JH wrote the protocol. The review will be co-ordinated by
JC. JC, with the assistance of Sylvia Bickley (Trials Search Co-ordinator, Cochrane Oral Health Group), will develop the search strategy
and undertake the electronic searches. JC will undertake the handsearching. JC and JH will screen the search results and retrieved
papers, appraise the quality of the papers and abstract data from them. Helen Worthington will check the data extraction, undertake
the data analysis and assist with the interpretation of the data. JC and JH will write the review.
DECLARATIONS OF INTEREST
The participating reviewers declare that there is no financial conflict of interest and that they do not have any associations with industry
regarding the subject of this review.
SOURCES OF SUPPORT
External sources
• No sources of support supplied