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

Koshy 2005.

Study characteristics
Methods Study design: RCT with 3‐arm parallel design
Recruitment period: unclear
Setting: university dental clinic, Japan
Number of centres: 1
Funding source: grant from Scientific Society
Participants Inclusion criteria: diagnosis of chronic periodontitis with PD ≥ 5 mm. All participants in good general health
Exclusion criteria: SRP in past 6 months or on antibiotics from 6 months before or during study, smokers, pregnancy, allergic to iodine
Age: 34–66 years
Sex: 23 F (FMD: 8; FMS: 7; control: 8) and 13 M (FMD: 4; FMS: 5; control: 4)
Smokers: 0
Number randomised: 36 (12 per group); all Japanese
Number evaluated: 36 (12 per group)
Interventions Comparison: FMS vs control; FMD vs control; FMS vs FMD
FMS group: (FMS + water): FMS 1 session US scaling with water (duration 2–2.5 hours)
FMD group: (FMS + povidone): FMS 1 session US scaling with 1% povidone iodine (duration 2–2.5 hours), participants rinsing with CHX 0.05% twice a day for 1 month, tongue brushing
Control group: (QMD) QRP 4 sessions US scaling with water at 1‐week intervals (duration 40–50 minutes each)
OHI before study start: yes
Instruments used: US instruments
Time per Q: unclear
Maintenance: every month
Retreatment: none
Duration of study: 6 months
Outcomes Primary outcome: PPD (6 sites per tooth)
Secondary outcomes: PAL, BOP (6 sites per tooth). Manual probe with stent for all measurements
Teeth: whole‐mouth recordings (baseline, 1, 3 and 6 months). Data split in single‐/multi‐rooted teeth and initial moderate (PPD 5–6 mm) and deep pockets (PPD > 6 mm)
Pocket depth at baseline: moderate (5 to < 7 mm), deep (≥ 7 mm)
Outcome time reported: 6 months used
Other outcomes: PI, mean pain VAS score (0–10), body temperature, number of analgesics, microbiology
Notes PAL is equal to RAL.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The random sequence was computer generated, with no stratification or balancing of factors".
Allocation concealment (selection bias) Low risk Quote: "The subjects chose a sequentially numbered opaque, sealed envelope, which enclosed the code for the treatment protocol they were to receive. The number of envelopes was same as the number of subjects".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The treatment groups were coded so that only the operator was aware of the protocol and the examiner remained blinded throughout the study".
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed study.
Selective reporting (reporting bias) Low risk Data reported on all primary and secondary outcomes.
Other bias Low risk Baseline balance good for pocket depth. No apparent other biases.