Cochrane · intervention · CD003976

Pharmacological interventions for pain relief during orthodontic treatment

Monk, AB, Harrison, JE, Worthington, HV, et al. · Cochrane Database of Systematic Reviews · 2017 · Cochrane Library

Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
34
current version
GRADE rated
12
No studies
18
Included studies
32
as reported
No studies 18 · 52.9%Ungraded 4 · 11.8%Very low 6 · 17.6%Low 3 · 8.8%Moderate 3 · 8.8%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Review question

ElementPlanned (methods)Found (results)
PopulationParticipants of any age receiving any type of orthodontic treatment. Excluded participants who had undergone surgical interventions, placement of temporary anchorage devices, or dental extractions in combination with orthodontic treatment.3110 participants randomized (2348 analyzed), aged 9 to 34 years; generally comparable numbers of males and females (one study female-only: Farzanegan 2012).
InterventionOpioid analgesics; any NSAID; paracetamol; local anaesthetic. Any intervention by any route, dose, form or combination, at any time during treatment (up to two hours before treatment).Tramadol (n=1); Paracetamol (n=8); Ibuprofen (n=16); Aspirin (n=1); Etoricoxib (n=1); Flurbiprofen (n=1); Meloxicam (n=1); Naproxen sodium (n=2); Lumiracoxib (n=1); Piroxicam (n=1); Ketoprofen (n=2); Valdecoxib (n=1); Tenoxicam (n=1); Benzocaine (n=4)
ComparisonAnother pharmacological intervention, a placebo, or no intervention; or the same intervention at a different dose, intensity or time interval.Placebo (n=21); No treatment (n=11)
OutcomesPrimary: participant-reported pain intensity or relief (VAS, NRS or any categorical scale). Secondary: rescue analgesia; adverse effects (harms); quality of life or participant satisfaction; time off school or work; failure to complete orthodontic treatment due to pain.Pain intensity (n=32); Rescue analgesia (n=7); Adverse events (n=2); Quality of life/participant satisfaction (n=2); Time off school or work (n=0); Failure to complete treatment (n=0)
Study designsRandomized controlled trials (RCTs) where a pharmacological intervention for pain relief was compared to a placebo, no intervention, or another pharmacological intervention; split-mouth studies excluded.32 RCTs (33 references); 17 studies had more than two arms; overall risk of bias low in 1, unclear in 10, high in 21 studies.
Timing2 hours, 6 hours and 24 hours following the orthodontic procedure (placement or adjustment of appliance).Data analyzed at 2, 6 and 24 hours; studies recorded 23 time points ranging from 1 hour pre-treatment to 30 days post-treatment.

Search date: 2017-06-19. Databases: Cochrane Oral Health Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; CINAHL EBSCO; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform

Questions and results

Show all 2 versions

Analgesic (any: NSAID, paracetamol, local anaesthetic or opioid) vs Control (placebo or no treatment)

Population: People undergoing orthodontic treatment (any age; 9 to 34 years in included studies)
8 questions
OutcomeEffectEvidenceStatus / GRADE
Quality of life or participant satisfaction
Reported narratively by 2 studies (Wang 2012: SF-36 and SAS - significant reduction in SF-36 bodily pain at 30 days vs baseline, no significant between-group differences; Minor 2009: STAI and PANAS - no significant…2 studiesUngraded
Pain intensity (VAS 0-100 mm)
24 hours
MD -21.19 [-28.31, -14.06]12 studies · 1012 participantsModerate
Downgraded: risk of bias
Pain intensity (VAS 0-100 mm)
6 hours
MD -24.27 [-31.44, -17.11]9 studies · 535 participantsModerate
Downgraded: risk of bias
Time off school or work
No studies in this comparison reported this outcome.0 studiesNo studies
Adverse events
No studies in this comparison reported any adverse events. SoF cell: 'Not reported'.0 studiesNo studies
Pain intensity (VAS 0-100 mm)
2 hours
MD -11.66 [-16.15, -7.17]10 studies · 685 participantsModerate
Downgraded: risk of bias
Rescue analgesia
Use of rescue analgesia recorded in 7 studies; only 2 reported counts (Tuncer 2014: 2 participants; Bruno 2011: 6 participants); no class/dose/timing reported; not pooled. SoF cell: 'Not reported'.7 studiesUngraded
Failure to complete orthodontic treatment due to pain
No studies reported this outcome.0 studiesNo studies

NSAID (systemic) vs Paracetamol

Population: People undergoing orthodontic treatment (any age; 9 to 34 years in included studies)
8 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse events
In one study, one participant (<1%) in the paracetamol group experienced drug hypersensitivity (a 'red, blotchy and itchy rash') that resolved without treatment within 1 week (Bradley 2007 / McAlinden 2005); 1 RCT;…1 studyVery low
Downgraded: imprecision
Time off school or work
No studies in this comparison reported this outcome.0 studiesNo studies
Rescue analgesia
RR 1.5 [0.6, 3.6]
91 per 1000 vs 136 per 1000
1 study · 159 participantsVery low
Downgraded: imprecision
Pain intensity (VAS 0-100 mm)
6 hours
MD -5.17 [-11.71, 1.37]7 studies · 664 participantsLow
Downgraded: risk of bias, imprecision
Quality of life or participant satisfaction
No studies in this comparison reported this outcome.0 studiesNo studies
Pain intensity (VAS 0-100 mm)
24 hours
MD -0.51 [-8.93, 7.92]9 studies · 734 participantsLow
Downgraded: risk of bias, imprecision
Pain intensity (VAS 0-100 mm)
2 hours
MD -2.92 [-8.48, 2.65]7 studies · 664 participantsLow
Downgraded: risk of bias, imprecision
Failure to complete orthodontic treatment due to pain
No studies in this comparison reported this outcome.0 studiesNo studies

Ibuprofen taken pre-emptively (about 1 hour before treatment) vs Ibuprofen taken post-treatment

Population: People undergoing orthodontic treatment (any age; 9 to 34 years in included studies)
8 questions
OutcomeEffectEvidenceStatus / GRADE
Rescue analgesia
RR 0.8 [0.3, 1.9]
316 per 1000 (post-treatment) vs 253 per 1000
2 studies · 41 participantsUngraded
Pain intensity (VAS 0-100 mm)
24 hours
MD -9.74 [-47.88, 28.40]2 studies · 69 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Time off school or work
No studies in this comparison reported this outcome.0 studiesNo studies
Failure to complete orthodontic treatment due to pain
No studies in this comparison reported this outcome.0 studiesNo studies
Pain intensity (VAS 0-100 mm)
2 hours
MD -11.30 [-16.27, -6.33]1 study · 41 participantsVery low
Downgraded: risk of bias, imprecision
Quality of life or participant satisfaction
No studies in this comparison reported this outcome.0 studiesNo studies
Pain intensity (VAS 0-100 mm)
6 hours
MD -8.43 [-30.37, 13.50]2 studies · 69 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Adverse events
No studies in this comparison reported any adverse events.0 studiesNo studies

Topical NSAID (ketoprofen chewing gum) vs Local anaesthetic (benzocaine chewing gum)

Population: People undergoing orthodontic treatment (any age; 9 to 34 years in included studies)
5 questions
OutcomeEffectEvidenceStatus / GRADE
Time off school or work
The study did not report this outcome.0 studiesNo studies
Failure to complete orthodontic treatment due to pain
The study did not report this outcome.0 studiesNo studies
Quality of life or participant satisfaction
The study did not report this outcome.0 studiesNo studies
Pain intensity (VAS 0-100 mm)
2 hours
MD 13 [-3.45, 29.45]1 study · 48 participantsVery low
Downgraded: risk of bias, imprecision
Adverse events
The study did not report this outcome.0 studiesNo studies

Topical NSAID (ketoprofen lysinate mouthwash, 160 mg) vs Topical NSAID (benzidamine hydrochloride mouthwash, 22.5 mg)

Population: People undergoing orthodontic treatment (any age; 9 to 34 years in included studies)
5 questions
OutcomeEffectEvidenceStatus / GRADE
Adverse events
The study did not report this outcome.0 studiesNo studies
Quality of life or participant satisfaction
The study did not report this outcome.0 studiesNo studies
Pain intensity (VAS)
4 days (not usable)
One study (Lauritano 2000) compared ketoprofen 160 mg with benzidamine chloride 22.5 mg mouthwashes; it presented data at 4 days only, so the data could not be used in this review; no GRADE rating.1 studyUngraded
Failure to complete orthodontic treatment due to pain
The study did not report this outcome.0 studiesNo studies
Time off school or work
The study did not report this outcome.0 studiesNo studies