Biesbrock 2007.
Methods | Trial design: parallel group, (6 arms) Location: USA Number of centres: not reported Recruitment period: not reported |
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Participants | Inclusion criteria: healthy adult participants between 18 and 70 years of age, brushing at least twice daily Exclusion criteria: less than 16 natural teeth, orthodontic appliances, removable partial dentures, extensive dental treatment needs, pre‐medication needs for dental care, history of antibiotic usage two weeks prior to study initiation, pregnancy, or nursing Baseline plaque: not reported Baseline periodontal status: at least 15 Löe‐Silness bleeding sites at screening; at least twice‐daily brushing Age: range 18 to 69 years (numbers for each group not reported) Sex: 31% males/69% females, numbers for each group not reported Number randomised: 179 (Gp A 28; Gp B 29 ; Gp C 30; Gp D 29; Gp E 30; Gp F 28) Intervention groups relevant to review: Gp A and Gp B Number evaluated: 174 (numbers for each group not reported) Smoking status: not reported |
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Interventions |
Comparison: powered toothbrushing and automated flossing versus powered toothbrushing Gp A (n = 28 evaluated) oscillating/rotating power toothbrush (Oral‐B Professional) and Crest® Pro‐Health™ dentifrice plus power flosser (Oral‐B Hummingbird, Procter & Gamble Co) twice a day Gp B (n = 29 evaluated) oscillating/rotating power toothbrush (Oral‐B Professional) and Crest® Pro‐ Health™ twice a day Duration of intervention: 8 weeks Other interventions (not included in the review): Gp C (n = 30) manual toothbrush Colgate Wave plus Colgate Total toothpaste Gp D (n = 29) manual toothbrush Colgate Wave plus Colgate Total toothpaste plus essential oil rinse (Listerine) Gp E (30): manual toothbrush Oral‐B CrossAction plus Crest® Pro‐Health™ dentifrice Gp F (n = 28) manual toothbrush Oral‐B CrossAction + Pro‐Health™ cetylpyridinium chloride rinse Baseline cleaning: dental prophylaxis administered after assessment of eligibility Training: participants received written (test kit) and verbal (supervised) instructions on product usage. Compliance assessment: not reported |
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Outcomes | Measurements: at baseline, 4 weeks, and 8 weeks Dental plaque and calculus: Navy Plaque Index (Rustogi Modification) on buccal and lingual surfaces Periodontal disease ‐ gingivitis: Löe & Silness Gingival Index on six surfaces Adverse effects: product‐related adverse events recorded at each visit; assessed by blinded oral examination Attrition: 5 participants lost to follow‐up; however, it was stated that: "no subject discontinued treatment due to product‐related adverse events" |
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Funding | Supported by Procter & Gamble. Three authors P & G employees | |
Notes | Crest® Pro‐Health™ dentifrice contains 0.454% stannous fluoride/sodium hexametaphosphate. Examiners training or calibration not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Eligible subjects were stratified based on gender and the number of baseline bleeding sites... and randomly assigned to one of six test regimens." Comment: method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding of participants was not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All test products were distributed in blinded kit boxes, instructions were provided remotely from examination" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "No subject discontinued treatment due to product‐related adverse events." Comment: 5 participants did not complete the eight‐week study. Number of participants lost to follow‐up in each of the groups could not be ascertained from the report, but can be estimated at 1 to 2 per group. Attrition was low (5 out of 179) and balanced between groups, therefore unlikely to affect results. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. Adverse events were recorded at each visit and the study reported that no participant discontinued treatment due to product‐related adverse events, but did not state whether there were any adverse events.. |
Other bias | Unclear risk | Compliance not assessed |