Schiff 2006.
Methods | Trial design: parallel (3 arms) Location: San Francisco, USA (type of setting not reported) Number of centres: 1 Recruitment period: not reported Funding source: "This study was supported by the Colgate‐Palmolive Company" |
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Participants | Inclusion criteria: healthy adults; minimum 20 uncrowned permanent natural teeth (excluding third molars); mean baseline modified Quigley‐Hein Plaque Index score of 1.5 or more and mean baseline Löe‐Silness Gingival Index score of 1.0 or more Exclusion criteria: wearing orthodontic appliances; wearing removable prostheses; tumours of the oral soft or hard tissues; advanced periodontal disease; 5 or more carious lesions requiring immediate restorative treatment; history of allergy to personal care/consumer products or their ingredients; use of any prescription medication that might interfere with the study outcomes; pregnant or lactating women; use of antibiotics during the 1 month before the study began; participation in any other clinical study or test panel during the 1 month before the study began Baseline plaque: (Quigley‐Hein Plaque Index) Gp A: mean 2.02 (SD 0.25); Gp B: mean 1.98 (SD 0.24) Baseline gingivitis: (Löe‐Silness Gingival Index) Gp A: mean 1.02 (SD 0.05); Gp B: mean 1.1 (SD 0.26) Baseline caries: not reported Age at baseline (years): Gp A: mean 28.3 (range 22‐46); Gp B: mean 27.3 (range 20‐50) Gender: Gp A: male 20 (54%), female 17 (46%); Gp B: male 22 (55%), female 18 (45%) Any other details of important prognostic factors: not reported Number randomised: not reported (120 across 3 arms with 5% attrition overall) Number evaluated: 77 (Gp A: 37; Gp B: 40) |
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Interventions |
Comparison: triclosan/copolymer/sodium fluoride plus flossing versus triclosan/copolymer/sodium fluoride without flossing* versus sodium fluoride plus flossing *We excluded this arm from our data extraction, risk of bias assessment and analyses Gp A (n = 37 evaluated): twice daily brushing for 1 minute with toothpaste containing 0.3% triclosan, 2% copolymer, 0.243% sodium fluoride, plus flossing once daily after brushing; all participants received thorough baseline oral prophylaxis and a red disclosing solution was used to confirm complete plaque removal; asked to refrain from using any other oral hygiene products and routine (non‐emergency) dental treatment during the study period Gp B (n = 40 evaluated): as above but without triclosan and copolymer Duration of treatment: 6 months |
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Outcomes | Plaque (Quigley‐Hein Plaque Index), gingivitis (Löe‐Silness Gingival Index), adverse effects; assessed at 3 and 6 months' follow‐up | |
Notes | Sample size calculation: not reported Adverse effects: none observed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...randomly assigned" Comment: insufficient information on the method of sequence generation Additional information from correspondence: simple randomisation using random number tables |
Allocation concealment (selection bias) | Low risk | Quote: "...randomly assigned" Comment: not mentioned Additional information from correspondence: a rigorous allocation procedure was carried out by people not involved in the study and we are satisfied that this was properly concealed from those involved in the study |
Blinding of participants (performance bias) All outcomes | Low risk | Quote: "examiner blind" and "All dentifrice products were packaged in their original tubes, but over‐wrapped with a white label to ensure that neither the subject nor the examiner would be aware of the identity of the product" Comment: as we have excluded the arm without flossing, the use of an identical control toothpaste plus flossing in the remaining arms meant that participants did not know which group they were assigned to, and this study can be considered double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "examiner blind" and "All dentifrice products were packaged in their original tubes, but over‐wrapped with a white label to ensure that neither the subject nor the examiner would be aware of the identity of the product" Comment: the examiner did not know which group the participants they were assessing had been assigned to |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 5% of randomised participants were not included in the final analysis, when considering all 3 arms. Attrition was not reported by group and reasons were not given, but authors stated that reasons were not related to any of the treatment regimens Comment: we do not believe that any of the above could pose a risk of bias significant enough to have led to a distortion of the true intervention effect |
Selective reporting (reporting bias) | Low risk | Appropriate outcome measures were considered and reported in full, as described in the methods section |
Other bias | Low risk | No mention of calibration of outcome assessor so it is unclear whether or not there was a risk of differential diagnostic activity Additional information from correspondence: this study followed a protocol whereby all outcome assessors were highly trained in the indices and procedures used, and inter‐ and intra‐examiner calibration occur where practical. Therefore, we consider that the risk of differential diagnostic activity is low. We were unable to identify any other potential source of bias |