To test the hypothesis that there is insufficient evidence available, from clinical trials, to allow evidence-based decisions to be made on the effectiveness of orthodontic treatment.
Objectives
To identify reports of orthodontic clinical trials and assess their demographic characteristics.
Design
A retrospective, observational study.
Setting
The American Journal of Orthodontics and Dentofacial Orthopedics, British Journal of Orthodontics, and European Journal Orthodontics.
Data source
Clinical trials published between 1989 and 1998.
Method
A hand-search was performed to identify all clinical trials. The journal and year of publication, research method, interventions, and sample size of the trials reported were recorded.
Results
One-hundred-and-fifty-five trial reports were identified of which 56 (36.1%) were published from 1989 to 1993 and 99 (69%) from 1994 to 1998. Ninety-nine (69%) reports were published in the AJO-DO, 18 (11.6%) in the BJO and 38 (24.5%) in the EJO. Eighty-five (54.8%) were reports of randomized controlled trials and 70 (45.2%) of controlled clinical trials. The interventions most frequently assessed were bonding materials (21.9%), growth modification treatments (21.3%), and oral hygiene procedures (9.0%). The median sample size was 32 (IQR 19.5, 50).
Conclusion
There is sufficient evidence available from clinical trials to warrant doing systematic reviews of orthodontic clinical trials to aid decision-making.
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References
1.
DollRControlled trials: the 1948 watershed. BMJ1998; 317: 1217–1220.
2.
YoshiokaAUse of randomisation in the Medical Research Council's clinical trial of streptomycin in pulmonary tuberculosis in the 1940s. BMJ1998; 317: 1220–1223.
3.
Medical Research Council (MRC).Streptomycin treatment of pulmonary tuberculosis. BMJ1948; 2: 769–782.
4.
BaumrindS, KornEL, BoydRL, MaxwellRThe decision to extract: Part I—interclinician agreement. Am J Orthod Dentofacial Orthop1996; 109: 297–309.
5.
BaumrindS, KornEL, BoydRL, MaxwellRThe decision to extract: Part II—Analysis of clinicians’ stated reasons for extraction. Am J Orthod Dentofacial Orthop1996; 109: 393–402.
6.
TullochJFC, PhillipsC, KochG, ProffitWR., The effects of early intervention on skeletal pattern in Class II malocclusion: A randomized clinical trial. Am J Orthod Dentofacial Orthop1997; 111: 391–400.
7.
TullochJFC, PhillipsC, ProffitWR., Benefit of early Class II treatment: Progress report of a two-phase randomised clinical trial. Am J Orthod Dentofacial Orthop1998; 113: 62–72.
8.
GhafariJ, ShoferFS, Jacobsson-HuntU, MarkowitzDL, LasterLL. Headgear versus functional regulator in the early treatment of Class II, Division 1 malocclusion: a randomised clinical trial. Am J Orthod Dentofacial Orthop1998; 113: 51–61.
9.
KeelingSD, WheelerTT, KingGJ, GarvanCW, CohenDA, CabassaS, Antero-posterior skeletal and dental changes after early Class II treatment with bionators and headgear. Am J Orthod Dentofacial Orthop1998; 113: 40–50.
10.
Cochrane Collaboration Oral Health Group.Oral Health Review Group Journal hand-searchers’ manual. Manchester: Cochrane Oral Health Group, 1999.
HarrisonJE, AshbyD, LennonMAAn analysis of papers published in the British and European journals of orthodontics. Br J Orthod1996; 23: 203–209.
13.
LandisJR, KochGGThe measurement of observer agreement for categorical data. Biometrics1977; 33: 159–174.
14.
FeinsteinARClinical biostatistics XLIV. A survey of the research architecture used for publications in general medical journals. Clin Pharmacol Ther1978; 24: 117–125.
15.
FletcherRH, FletcherSWClinical research in general medical journals. N Engl J Med1979; 301: 180–183.
16.
HainesSJRandomised clinical trials in the evaluation of surgical intervention. J Neurosurg1979; 51: 5–11.
17.
MorrisRWA statistical study of papers in theJournal of Bone and Joint Surgery. J Bone Joint Surg Br1984; 70: 242–246.
18.
TullochJFC, Antczak-BouckomsAA, TuncayOC. A review of clinical research in orthodontics. Am J Orthod Dentofacial Orthop1989; 95: 499–504.
19.
RobertsCT, SembG, ShawWCStrategies for the advancement of surgical methods in cleft lip and palate. Cleft Palate Craniofac J1991; 2: 141–149.
20.
PollockAVSurgical evaluation at the cross-roads. Br J Surg1993; 80: 964–966.
21.
GluudC, NickolovaDQuality assessment of reports on clinical trials in theJournal of Hepatology. J Hepatol1998; 2: 321–327.
22.
TullochJFCBias and variability in clinical research. Clin Orthod Res1998; 1: 94–96.
23.
JohnsonLELet them eat cake: the struggle between form and substance in orthodontic clinical investigation. Clin Orthod Res1998; 1: 88–93.
24.
VigKWL, WeyantR, VaydaD, O'BrienK, BennettE.Orthodontic process and outcome: efficacy studies—Strategies for developing process and outcome measures: a new era in orthodontics. Clin Orthod Res1998; 1: 147–155.
25.
EllenbergSSStudies to compare treatment regimens: the randomised clinical trial and alternative strategies. JAMA1981; 246: 2481–2482.
26.
GrossMA critique of the methodologies used in clinical studies of hip-joint arthroplasty published in the English-language orthopedic literature. J Bone Joint Surg Am1988; 70: 1364–1371.
27.
O'BrienKD, CorkillCM. The specialist orthodontic practitioner. The 1989 survey. Br Dent J1990; 168: 471–475.
28.
FrickerJPA new self-curing resin-modified glass-ionomer cement for the direct bonding of orthodontic brackets in vivo. Am J Orthod Dentofacial Orthop1998; 113: 384–386.
29.
Armas GalindoHR, SadowskyPL, VlachosC, JacobsonA., WallaceD.An in vivo comparison between a visible light-cured bonding system and a chemically cured bonding system. Am J Orthod Dentofacial Orthop1998; 113: 271–275.
30.
SadowskyPL, RetiefDH, CoxPR, Hernandez-OrsiniR, RapeWG, BradleyEL. Effects of etchant concentration and duration on the retention of orthodontic brackets: an in vivo study. Am J Orthod Dentofacial Orthop1990; 98: 417–421.
31.
IllingHM, MorrisDO, LeeRTA prospective evaluation of Bass, Bionator and Twin Block appliances. Part I—the hard tissues. Eur J Orthod1998; 20: 501–516.
32.
BrightmanLJ, TerezhalmyGT, GreenwellH, JacobsM, EnlowDHThe effects of a 0.12 per cent chlorhexidine gluconate mouthrinse on orthodontic patients aged 11 through 17 with established gingivitis. Am J Orthod Dentofacial Orthop1991; 100: 324–329.
33.
TrimpeneersLM, WijgaertsIA, GrognardNA, DermautLR, AdriaensPAEffect of electric toothbrushes versus manual toothbrushes on the removal of plaque and periodontal status during orthodontic treatment. Am J Orthod Dentofacial Orthop1997; 111: 492–497.
34.
DenesJ, GabrisKResults of a 3-year oral hygiene programme, including amine fluoride products, in patients treated with fixed orthodontic appliances. Eur J Orthod1991; 13: 129–133.
35.
FreimanJA, ChalmersTC, SmithHJr, KueblerRR. The importance of beta, type II error and sample size in the design and interpretation of the randomized controlled trial. Survey of 71 ‘negative’ trials. N Engl J Med1878; 299: 690–694.
36.
AltmanDGHow large a sample?. BMJ1980; 281: 1336–1338.
37.
AltmanDG. Practical Statistics for Medical Research. London: Chapman & Hall, 1991. pp. 455–460
38.
MoherD, DulbergCS, WellsGAStatistical power, sample size and their reporting in randomised controlled trials. JAMA1994; 272: 122–124.
39.
DickinsonK, BunnF, WentzR, EdwardsP, RobertsISize and quality of randomised controlled trials in head injury: review of published studies. BMJ2000; 320: 1308–1311.
