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. 2022 Jun 28;2022(6):CD004622. doi: 10.1002/14651858.CD004622.pub4

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
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)
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
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
Notes Dropouts: 45 enrolled, 40 completed the study. Time point for dropouts unclear
For BOP: data extracted from graphs
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.