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 |
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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) |
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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 |
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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 |
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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. |