Benson 2012.
| Methods | Trial design: RCT, 2 groups Location: Charles Clifford Hospital, Sheffield, UK Number of centres: 1 |
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| Participants | SELECTION CRITERIA • Aged up to 18 years The following exclusion criteria were applied. • Patients with a cleft of the lip or palate • Patients with phenylketonuria (who must avoid products containing aspartame or artificial sweeteners which contain phenylalanine) • Significant medical history • Poor dental or periodontal health precluding the use of fixed appliances • Undergoing orthodontic treatment with fixed upper and lower appliances Participants: 68 Number randomised: 68 (intervention: 37; control: 31) Number evaluated: 57 (intervention: 29; control: 28) (31 male, 26 female) Mean age: 14.7 (SD 1.5) years intervention group, 13.9 (SD 1.6) control group |
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| Interventions | INTERVENTION: Chewing gum (Wrigley's Orbit Complete) for as‐required use at the bonding/separator appointment and subsequent appointments up to the visit after the placement of the working arch wire (0.019 × 0.025 mm stainless steel) CONTROL: Non‐chewing gum group, specifically asked not to chew gum for the duration of the study |
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| Outcomes | The primary outcome was the Total Impact Score (TIS) reported by the participants at 24 hours and 1 week after placement of the brace. Secondary outcomes included assessment of pain using the VAS measurements at 24 hours and 1 week and reported use of oral analgesics | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...using computer‐generated random numbers" (p. 180) |
| Allocation concealment (selection bias) | Low risk | "The allocations were concealed in consecutively numbered opaque sealed envelopes, which were opened only after the patient and parent had agreed to enter the trial and had signed the consent form." (p. 180) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Efforts to blind operators to group allocation was undertaken where possible: "Masking of the patient to group allocation was not possible because they were either asked to chew gum or not. Masking of the operator was undertaken where practical; however this was not always possible." (p. 180) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of chief assessors (participants) "Masking of the operator was undertaken where practical; however this was not always possible" (p. 180) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 57 of 68 randomised participants were analysed. Reasons for failure to complete including drop‐out, failure to complete diaries and an administrative error were outlined Comment: Failure to complete was reported with the reason given and these represented fewer than 20% of the sample |
| Selective reporting (reporting bias) | Low risk | Study protocol not available, but outcomes mentioned in the methods section appeared to have been reported |
| Other bias | Low risk | Appeared to be free of other forms of bias |