Jared 2005.
Methods | Trial design: parallel group, 5 arms Location: The University of North Carolina, USA Number of centres: 1 Recruitment period: not reported |
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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) |
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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 |
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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. |
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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. |