Finkelstein 1990.
Methods | Trial design: parallel group, 5 arms Location: New Jersey, USA Number of centres: 1 Recruitment period: not reported |
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Participants | Inclusion criteria: adults with at least 20 uncrowned teeth and a commitment to adhere to the test protocol, occasional flossing (1 to 3 times per week) Exclusion criteria: removable prostheses, gross oral pathology, dental prophylaxis within the last 3 months Baseline plaque: not reported Baseline periodontal status: at least 10 interdental bleeding sites measured by the EIBI Age at baseline: not reported Sex: not reported Number randomised: 161 (Gp A 31; Gp B 30; Gp C 32; Gp D 33; Gp E 32) (although 161 participants were randomised, only 158 started the study) Number evaluated: 158 (Gp A 31; Gp B 30; Gp C 32; Gp D 33; Gp E 32) Smoking status: not reported |
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Interventions |
Comparisons: manual toothbrushing versus manual toothbrushing and floss versus manual toothbrushing and a wooden interdental cleaner Gp A (n = 31 evaluated) wooden interdental cleaner (Stim‐U‐Dent), Johnson & Johnson Gp B (n = 30 evaluated) manual waxed floss (Johnson & Johnson) Gp E (n = 32 evaluated) manual toothbrushing All participants received a manual toothbrush (Oral B Indicator) and Colgate Cavity Protection toothpaste Toothbrushing was carried out "ad lib" throughout Duration of intervention: 12 weeks Other interventions (not included in the review): Gp C: essential oil mouthrinse (Listerine Antiseptic) Gp D: cetylpyridinium chloride mouthrinse (Cepacol, Merrel Dow Pharmaceutical) Training: no training was reported as having been provided. It was stated that each product was used according to the manufacturers directions. Baseline cleaning: not reported as having been undertaken Compliance assessment: not reported |
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Outcomes | Measurements: at week 0, week 6, and week 12 Dental plaque: Global Plaque Index Periodontal disease ‐ gingivitis: Löe & Silness Gingival Inflammation Index (VGI) and Eastman Interdental Bleeding Index (EIBI) Adverse effects: not reported Attrition: 3 randomised participants did not start the study. |
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Funding | Funded by a grant from Johnson & Johnson Dental Care Company; lead author J & J employee | |
Notes | Examiner training or calibration not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects were randomly assigned to one of the five test groups…" Comment: no further information on sequence generation |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants not possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three participants did not complete the study with no information on the reasons for lost to follow‐up; however we considered it unlikely to affect the results. |
Selective reporting (reporting bias) | High risk | No standard deviations reported; unable to use data |
Other bias | Unclear risk | Compliance not assessed. |