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

Jared 2005.

Methods Trial design: parallel group, 5 arms
Location: The University of North Carolina, USA
Number of centres: 1
Recruitment period: not reported
Participants Inclusion criteria: adults > 18 years old, at least 1 "test site" defined as an interproximal space of 1.0 mm that exhibited bleeding from the facial and lingual sides, excluding third molars
Exclusion criteria: current use of interdental cleaning devices (dental floss, proxy brush, stimudent) or in the past 6 months, no appropriately sized interdental space, participants that have brushed their teeth less than once a day in the past 6 months, oral disease requiring immediate treatment; smoking within the last 6 months, pregnancy, current use of antibiotics or any other medication known to cause gingival enlargement, chronic use of non steroidal anti‐inflammatory medications, immunocompromised patients, patients with a disease that affects the gingiva, need for antibiotic prophylaxis, orthodontic patients, patients who have undergone scaling in the last 6 months, presence of interproximal calculus sufficient enough to interfere with interdental cleaning, participation in another study
Baseline plaque status: Turesky modification of the Quigley‐Hein Index, mean Interproximal Plaque Score (IPS) value range from 2.82 to 2.99
Baseline periodontal status: Lobene modification of the Gingival Index (mean Interproximal Gingival Score (IGS) value range from 2.09 to 2.30
Age at baseline: mean age: 36.38 to 42.20
Sex: 60 males/92 females
Number randomised: 162 (not reported across groups)
Number evaluated: 152 (Gp A 31; Gp B 30; Gp C 30; Gp D 29; Gp E 32)
Smoking status: all non‐smokers (smoking within preceding 6 months was an exclusion criterion)
Interventions Comparison: manual toothbrushing versus manual toothbrushing and an interdental brush versus manual toothbrushing and floss
Gp C: (n = 30 evaluated) interdental brush (Sunstar Inc. Japan), used nightly after toothbrushing
Gp D: (n = 29 evaluated) dental floss (GUM Easy‐through Floss Sunstar Inc.) used nightly before toothbrushing
Gp E: (n = 32 evaluated) standard toothbrush alone
Other interventions (not included in the review):
Gp A: (n = 31 evaluated) interdental brush (Sunstar Inc. Japan) plus an 0.05% cetylpyridinium gel
Gp B: (n = 30 evaluated) interdental brush (Sunstar Inc. Japan) plus a placebo gel
All participants used manual toothbrush (GUM #409, Sunstar Inc) twice a day
Duration of intervention: 4 weeks
Baseline cleaning: before clinical data were collected, participants were asked to brush their teeth. After the baseline data collection, dental plaque was removed from all teeth using a rubber cup and fine grit prophylaxis paste
Training: participants received verbal and written oral hygiene instructions, as well as appropriate demonstrations of the mechanical cleaning procedures
Compliance assessment: participants were asked to keep a log of their dental cleaning habits, but data were not reported
Outcomes Measurements: at baseline, 2 weeks, and 4 weeks
Dental plaque: Quigley‐Hein Plaque Index (Turesky modification)
Periodontal disease ‐ gingivitis: Lobene modification of the Gingival Index; bleeding upon probing using the Van der Wijden modification of the Bleeding on Marginal Probing
Adverse effects: a questionnaire was given to all participants concerning any symptoms experienced; adverse effects were not reported in the Results.
Attrition: of the 10 participants who did not complete the study, 9 withdrew prior to baseline, and 1 was lost due to health issues. None of the withdrawals were product‐related.
Funding Supported by Sunstar Inc., Japan, and 3 authors were employees
Notes Almost all dropouts (9/10) occurred before baseline assessment. Chairside calibration of the examiner was conducted by an external gold‐standard examiner.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Block randomization was used, and was based on baseline dental plaque scores to assure greater baseline comparability among treatment groups"
Comment: details of method not provided
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 Quote: "single‐blind randomized clinical trial"
No other details provided on blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition reported and explained: "Of the 10 subjects who did not complete the study, nine withdrew prior to baseline, and one was dismissed due to health issues. None of the withdrawals were product‐related." We judged it unlikely to affect the results.
Selective reporting (reporting bias) Unclear risk Previously published abstract available. All primary outcomes in the Methods section were addressed in the Results section. However, data on possible adverse effects were not reported, although the participants were asked to keep logs.
Other bias Unclear risk Compliance was not reported, although participants were asked to keep a log of their dental cleaning habits.