Koshy 2005.
| Methods |
Study design: RCT with 3‐arm parallel design Recruitment period: unclear Setting: University Dental Clinic, Japan Number of centres: One Funding source: Grant from Scientific Society |
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| Participants |
Inclusion criteria: Diagnosis: Chronic periodontitis ‐ with PD of > 5mm. All patients were 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 to 66 Gender: 23 F (FMD/FMS/control 8/7/8) and 13 M (4/5/4) Smokers: 0 Number randomised: 36 all Japanese, 12 individuals in each group Number evaluated: 36 (12/12/12) |
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| Interventions |
Comparison: FMS vs control: FMD vs control: FMS vs FMD Test group 1: (FMD + water): FMS 1 session US scaling with water (duration 2 to 2.5 hours) Test group 2: (FMD + povidone): FMS 1 session US scaling with 1% povidone iodine (duration 2‐2.5 hours), patients rinsing with 0.05% CHX twice a day for 1 month, tongue brushing Control group: (QMD): QRP 4 sessions US scaling with water ‐ 1‐week intervals (duration 40‐50 min 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: RAL, 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 to 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, average pain VAS score (0 to 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 | "They were then randomly allocated to three groups based on the treatment protocol and the examiner was blinded to the allocation. The random sequence was computer generated, with no stratification or balancing of factors" |
| Allocation concealment (selection bias) | Low risk | "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" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The treatment groups were coded so that only the operator was aware of the protocol and the examiner remained blinded throughout the 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 |