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. 2019 Apr 10;2019(4):CD012018. doi: 10.1002/14651858.CD012018.pub2

Biesbrock 2007.

Methods Trial design: parallel group, (6 arms)
Location: USA
Number of centres: not reported
Recruitment period: not reported
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
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
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"
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
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