Cochrane Database of Systematic Reviews

Drug interventions for pain relief during orthodontic

treatment (Protocol)

Cooper JE, Harrison JE, Worthington HV

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.

www.cochranelibrary.com

Drug interventions for pain relief during orthodontic treatment (Protocol)

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Drug interventions for pain relief during orthodontic treatment (Protocol) i

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Drug interventions for pain relief during orthodontic

treatment

James E Cooper1 , Jayne E Harrison1 , Helen V Worthington2

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.

Editorial group: Cochrane Oral Health Group.

Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.

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:

The aims of this review are to determine:

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.

• functional appliances (braces that aim to move the teeth

BACKGROUND
Orthodontics is the area of dentistry concerned with the growth
of the jaws and face, the development of the teeth and the way
the teeth and jaws bite together. It also involves the treatment
of the teeth and jaws when they are irregular and/or bite in an
abnormal way. Orthodontics is usually carried out to improve the
functioning and appearance of the teeth. This may involve moving
teeth by applying a force to them via:
• fixed appliances (braces where the components are attached
to the teeth for the duration of the treatment);
• removable appliances (braces that can be removed from the
mouth for cleaning during treatment); and/or
Drug interventions for pain relief during orthodontic treatment (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
and modify the growth of the jaws. They can either be removable
from the mouth or fixed to the teeth during treatment).
Orthodontic treatment may also involve the extraction of teeth to
provide space to allow the teeth to be straightened and occasion-
ally jaw surgery to correct the position of the jaws. Most patients
undergoing orthodontic treatment are children or adolescents al-
though an increasing number of adults are seeking treatment.
Treatment usually starts with the placement of the appliance, usu-
ally over two 30 to 45 minute visits. Routine adjustments are car-
ried out every 4 to 6 weeks over the course of treatment that lasts
approximately 12 to 24 months. The removal of fixed appliances
takes about 30 to 45 minutes.
Pain resulting from orthodontic treatment increases in proportion
1
to the amount of force applied to the teeth. Different types of or- procedures associated with orthodontic treatment.
thodontic appliances (braces) may have an effect on the intensity
of the pain. Fixed orthodontic appliances seem to cause more pain
than functional appliances, which are used to help modify facial
OBJECTIVES
growth or removable braces (Sergl 1998). There is the acute pain
experience e.g. during or immediately after placement of separa- The aims of this review are to determine:
tors. Patients may also experience pain for 1 to 2 days (medium
term) following each adjustment appointment that occur every 4 1) the effectiveness of drug interventions for pain relief during
to 6 weeks. Pain may also be experienced acutely or continuously orthodontic treatment; and
in between adjustment visits (long term). 2) whether there is a difference in the analgesic effect provided
It is thought that the pain associated with orthodontic treatment by different types, forms and doses of analgesia taken during or-
is related to a reduction in the blood supply to the fibres that thodontic treatment.
attach the tooth to the surrounding bone. This happens when a
force is applied to the tooth via the brace. The reduction in blood
supply causes inflammation and the release of several chemicals METHODS
that greatly increase the transmission of painful stimuli (Proffit
2000).

Pain during orthodontic treatment has been shown to be the most
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-
tic tooth movement experienced more pain 24 hours after initial
arch wire placement than 24 hours after tooth extraction (Jones
1992). When separators (small rubber bands that make space for
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
levels have decreased to the same level as 2 hours following treat-
ment (Bernhardt 2001). The amount of pain experienced depends
upon the type of tooth movement occurring (tipping or bodily
movement) and especially the pain threshold of the individual. It
is likely that patients only require drug assisted pain relief for 2 to
3 days out of every 4 to 6 weeks so the long term implications of
the drug treatment are probably small.
Criteria for considering studies for this review
Types of studies
All randomised and quasi-randomised controlled clinical trials re-
lating to analgesia during orthodontic treatment.
Types of participants
Trials will be eligible for inclusion in the review if they have re-
cruited participants receiving any type of orthodontic treatment.
All age groups will be considered.
Trials assessing pain relief following tooth extraction or surgical
interventions, that are associated with orthodontics, will not be
included.

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.

We will be investigating relief of pain arising during and after the

placement of orthodontic appliances. This may include one or Controls
more of the following: separators, fixed braces, removable braces, Maybe a placebo or another active intervention or the same inter-
headgear and during routine treatment to adjust appliances. We vention at a different dose or
will not include pain relief following tooth extraction or surgical taken at a different time.

Drug interventions for pain relief during orthodontic treatment (Protocol) 2

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of outcome measures
Primary
Patient reported pain intensity/pain relief measured on a visual
analogue scale and/or categorical scale.
Duration of pain.
Secondary
Dose and frequency of pain relief needed.
Any rescue (alternative) pain relief taken/prescribed, including
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-
rienced.
Visual analogue scales and any categorical outcomes will be trans-
formed into dichotomous data and analysed as such.
Comparisons
1) Any analgesic at any dose taken at any time versus placebo at
any dose taken at any time. If there is evidence of effectiveness
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;
2.1) Subgroup analysis of type of opioid at any dose taken at any
time versus placebo at any dose taken at any time;
3) NSAID of any type, at any dose taken at any time versus placebo
at any dose taken at any time;
3.1) Subgroup analysis of type of NSAID at any dose taken at any
time versus placebo at any dose taken at any time;
4) Paracetamol at any dose taken at any time versus placebo at any
dose taken at any time;
4.1) Subgroup analysis of type of paracetamol at any dose taken
at any time versus placebo at any dose taken at any time;
5) Local anaesthetic at any dose given at any time versus placebo
at any dose taken at any time;
5.1) Subgroup analysis of type of local anaesthetic at any dose
taken at any time versus placebo at any dose taken at any time.
6) If there is evidence of effectiveness in any of the classes or
subgroups further analysis will be undertaken to determine the
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/
or type of analgesic.
8) Head to head comparisons of the best in each class and/or type
of analgesic.
Drug interventions for pain relief during orthodontic treatment (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Search methods for identification of studies
Electronic searching
For the identification of studies included or considered for this re-
view detailed search strategies will be developed for each database
searched. These will be based on the search strategy developed
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
(see Appendix 1), in conjunction with phases one and two of the
Cochrane sensitive search strategy for randomised controlled clin-
ical trials (RCTs) as published in the Cochrane Reviewers’ Hand-
book, Appendix 5c.
Databases to be searched
The following databases will be searched:
OHG Trials Register to current date;
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;
MEDLINE 1966 - present;
EMBASE 1980 - present;
CINAHL 1982 - present.
Handsearching
A check will be made to see which journals have already been hand-
searched as part of the Oral Health Group’s handsearching pro-
gramme. The handsearching of the following journals will then be
updated to the most current issue as appropriate: American Jour-
nal of Orthodontics and Dentofacial Orthopaedics; Angle Orthodon-
tist; European Journal of Orthodontics; Journal of Orthodontics; Aus-
tralian Journal of Orthodontics; Seminars in Orthodontics; Clinical
Orthodontics and Research.
If it appears, from searching the Cochrane Pain, Palliative and
Supportive Care Group Trials Register, that relevant studies are
being found in non-orthodontic journals then these will be hand-
searched as necessary.
The bibliographies of the clinical trials identified will be checked
for references to trials published outside the handsearched journals.
Personal references will be checked.
Language
Databases will be searched to include papers and abstracts pub-
lished in all languages and every effort will be made to translate
non-English papers.
3
Unpublished studies
The first named authors of all trial reports will be contacted in an
attempt to identify unpublished studies and to obtain any further
information about the trials.
Data collection and analysis
Study selection
Two review authors (James Cooper (JC) and Jayne Harrison (JH))
will independently assess the title and abstract (when available) of
all reports that are identified by the search strategy as being poten-
tially relevant to the review. The full report will then be obtained
for all studies that appear to meet the inclusion criteria or where
there is insufficient information to make a clear decision or where
there is disagreement between the review authors about eligibility.
The full reports will then be assessed to establish which studies
do meet the inclusion criteria. Disagreements will be resolved by
discussion between JC and JH or the involvement of Helen Wor-
thington (HW). A record of all decisions made about the poten-
tially eligible studies will be kept. The review authors will not be
blind to trial author(s), institution or site of publication. Agree-
ment will be assessed using the Kappa statistic (Landis 1977).
Data extraction
Two review authors (JC and JH) will independently record the
year of publication, interventions assessed, outcomes, sample size
and age of subjects. HW will check the data extraction.
The primary outcome will be the relief of pain. Harms (e.g. total
gastro-intestinal side effects) will be recorded and the results re-
ported in descriptive terms.
All outcome data will be extracted. It will then be grouped into
those measured pre-treatment i.e. at baseline, < 1 hour, < 6 hours,
< 12 hours, < 24 hours and < 48 hours following the orthodontic
procedure (placement or adjustment of appliance). If outcome
data are reported at other time points then consideration will be
given to examining these as well.
Quality assessment
Two review authors (JC and JH) will undertake the quality assess-
ment of the included trials independently and in duplicate as part
of the data extraction process. Disagreements will be resolved by
discussion between JC and JH or the involvement of HW.
Drug interventions for pain relief during orthodontic treatment (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Three main criteria will be examined:
a) allocation concealment recorded as adequate; unclear; inade-
quate or not used as described in the Cochrane Reviewers’ Hand-
book;
b) blind outcome assessment;
c) completeness of follow up and intention-to-treat analysis.
Data analysis
The Cochrane Collaboration statistical guidelines will be followed.
The data will be analysed by HW using RevMan and reported
according to Cochrane Collaboration criteria.
Heterogeneity will be assessed using Cochran’s test and, if signifi-
cant heterogeneity is detected, the significance of treatment effects
will be assessed using the random-effects model. Clinical hetero-
geneity will be examined by assessing the types of participants,
the interventions, doses taken and timing and outcomes of each
study. Data will only be pooled if there are studies of similar inter-
ventions taken by similar participants in similar doses at similar
times.
Sensitivity analyses will be undertaken to examine the effect of
allocation concealment, blind outcome assessment and complete-
ness of follow up. The effect of including unpublished studies on
the review’s findings will also be examined.
Risk ratio, the number needed to treat and corresponding 95%
confidence intervals will be calculated for dichotomous data. The
mean difference and 95% confidence intervals will be calculated
for continuous data.
Analyses of subgroups identifying different drug treatments and
different doses will carried out. Differences between adult and
child groups will be also be assessed.
Cross-over trials
The treatment effects from cross-over trials will be combined with
those from parallel group trials where appropriate, using the pro-
cedures outlined in Elbourne 2002. The methods of Follmann
1992 will be used to estimate the appropriate standard errors if
these are not presented in the trial reports.
ACKNOWLEDGEMENTS
We would like to acknowledge the assistance of Sylvia Bickley (Tri-
als Search Co-ordinator, Cochrane Oral Health Group) in devel-
oping the search strategy.
4
 REFERENCES

Additional references Landis 1977

Bernhardt 2001
Bernhardt M, Southard KA, Batterson K, Logan HL,
Baker K, Jakobsen JR. The effect of pre-emptive and/
or postoperative ibuprofen therapy for orthodontic
pain. American Journal of Orthodontics and Dentofacial
Orthopaedics 2001;120(1):20–7.
Elbourne 2002
Elbourne DR, Altman DG, Higgins JPT, Curtin F,
Worthington HV, Vail A. Meta-analyses involving cross-
over trials: methodological issues. International Journal of
Epidemiology 2002;31:140–9.
Follmann 1992
Follmann D, Elliott P, Suh I, Cutler J. Variance imputation
for overviews of Clinical trials with continuous response.
Journal of Clinical Epidemiology 1992;42:769–73.
Jones 1992
Jones M, Chan C. Pain in the early stages of orthodontic
treatment. Journal of Clinical Orthodontics 1992;26(5):
311–3.
Landis JR, Koch GG. The measurement of observer
agreement for categorical data. Biometrics 1977;33(1):
159–74.
Oliver 1985
Oliver R, Knapman Y. Attitudes to orthodontic treatment.
British Journal of Orthodontics 1985;12:179–88.
Proffit 2000
Proffit WR, Fields HW Jr. Contemporary Orthodontics.
Third Edition. St Louis, Missouri, USA: Mosby-Year Book,
Inc, 2000.
Sergl 1998
Sergl H, Klages U, Zentner A. Pain and discomfort
during orthodontic treatment: causative factors and effects
on compliance. American Journal of Orthodontics and
Dentofacial Orthopaedics 1998;114(6):684–91.
Steen Law 2000
Steen Law SL, Southard KA, Law AS, Logan HL, Jakobsen
JR. An evaluation of preoperative ibuprofen for the
treatment of pain associated with orthodontic separator
placement. American Journal of Orthodontics and Dentofacial
Orthopaedics 2000;118(6):629–35.
∗
Indicates the major publication for the study

APPENDICES

Appendix 1. MEDLINE (OVID) search strategy

#1 Explode ORTHODONTICS(ME)
#2 orthodontic*
#3 #1 OR#2
#4 PAIN (ME)
#5 FACIAL PAIN (ME)
#6 HEADACHE (ME)
#7 NEURALGIA (ME)
#8 EARACHE (ME)
#9 TOOTHACHE (ME)
#10 PAIN-MEASUREMENT (ME)
#11 pain* OR discomfort OR headache* OR migraine* OR neuralgi* OR earache* OR toothache Or odontalgi* OR (pain near
(manag* OR relief OR reliev OR control*))
#12 #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11
#13 Explode ANALGESICS (ME)
#14 analgesi*
#15 ANESTHETICS-LOCAL (ME)
#16 ((local OR topical) AND (anaesthetic* OR analgesi*)) OR ((local OR topical) AND (anesthetic* OR analgesi*))
#17 ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL (ME)
Drug interventions for pain relief during orthodontic treatment (Protocol) 5
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
#18 “Nonsteroidal Anti-Inflammatory Agent*” OR “Anti Inflammatory Agent*” OR “Nonsteroidal Antiinflammatory Agent*” OR
“Non Steroidal Antiinflammatory Agent” OR “Nonsteroidal Analgesic*” Or “Anti-Inflammatory” OR “Asprin-Like Agent*” or
NSAID*
#19 opioid
#20 aspirin
#21 paracetamol
#22 acetaminophen
#23 medication*
#24 #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23
#25 #3 AND #12 AND #24

WHAT’S NEW

Date Event Description

18 September 2008 Amended Converted to new review format.

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

Drug interventions for pain relief during orthodontic treatment (Protocol) 6

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Internal sources
• The Royal Liverpool and Broadgreen Hospitals NHS Trust, UK.
• The University of Manchester, UK.

External sources
• No sources of support supplied

Drug interventions for pain relief during orthodontic treatment (Protocol) 7

Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.