Zanatta 2006.
Study characteristics | ||
Methods |
Study design: RCT with 3‐arm parallel design Recruitment period: March 2004–July 2004 Setting: university dental clinic, San Paulo, Brazil Number of centres: 1 Funding source: unclear |
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Participants |
Inclusion criteria: diagnosis: chronic periodontitis with PD ≥ 5 mm and BOP. All participants in good general health Exclusion criteria: SRP in past 6 months or on antibiotics from 6 months before or during study, pregnancy, allergic to iodine Age: 27–72 years Sex: 18 F and 27 M Smokers: unclear Number randomised: 45 (15 per group) Number evaluated: 40 (FMS: 12; FMD: 15; control: 13) |
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Interventions |
Comparison: FMS vs control; FMD vs control; FMS vs FMD FMS group: (PDG) FMS 1 session US scaling with 0.9% slaine (duration 45 minutes) FMD group: (PD‐PIG): FMS 1 session US scaling with povidone iodine 0.5% (duration 45 minutes) Control group: QRP 4 sessions US scaling with water, 1‐week intervals (duration unclear) OHI before study start: yes Instruments used: US instruments Time per Q: unclear Maintenance: twice weekly from baseline Retreatment: none Duration of study: 3 months |
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Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: CAL, BOP (6 sites per tooth). Computerised probe with stent for all measurements Teeth: whole‐mouth recordings (baseline, 1 and 3 months). Data split initial moderate (PPD 5–6 mm) and deep pockets (PPD > 6 mm) Pocket depth at baseline: moderate (5–6 mm), deep (> 6 mm) Outcome time reported: 3 months used Other outcomes: PI, GR |
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Notes | Dropouts: 45 enrolled, 40 completed the study. Time point for dropouts unclear For BOP: data extracted from graphs |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to one of the following treatment groups…". |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "A previously calibrated examiner, masked to the type of treatment, performed all clinical assessments". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Low dropout (5/45) and numbers by group given but reasons not given. |
Selective reporting (reporting bias) | Low risk | Data reported on all primary and secondary outcomes. |
Other bias | Unclear risk | Baseline balance good for pocket depth but smoking is unclear. No apparent other biases. |