Methods | Country: UK Recruitment: occurred in a single hospital‐based periodontal clinic Randomized controlled trial |
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Participants | 118 smoking adults attending consultant clinics in an outpatient dental hospital periodontal clinic | |
Interventions | 1. Intervention group ‐ 5 A's, NRT prn (patches, gum) 2. Usual care ‐ Received information regarding the role of tobacco in periodontal disease, 'very brief' advice to quit smoking |
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Outcomes | 3, 6, 12m PP tobacco abstinence. Repeated PP (3, 6, 12m) used in analyses 12m cotinine measured for self reported quitters. |
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Notes | CO <8 ppm, COT <20 ng/ml cutoffs for quit status | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization process was set up by the project statistician and was implemented independently from the recruitment process. After recruitment, the patient's name was transcribed into a log book containing sequential patient log numbers and the allocated hygienist. |
Allocation concealment (selection bias) | Low risk | After allocating the patient to a hygienist, the patient was allocated to either intervention or control group using the minimization method. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Significant loss to follow‐up for both groups; 34/57 for control, 26/59 for intervention. |