Predin 2014.
Study characteristics | ||
Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: unknown Setting: university dental hospital, Serbia Number of centres: 1 Funding source: research grant No. 175075 from the Ministry of Education and Science of Serbia |
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Participants |
Inclusion criteria: diagnosis with chronic periodontitis Exclusion criteria: medical disorders, SRP in past 6 months or on antibiotics from 3 months before or during study, pregnancy Age: 32–75 years Sex: 31 F (FMS: 16; control: 15) and 9 M (FMS: 4; control: 5) Smokers: FMS: 4; control: 3 Number randomised: 48 (24 per group) Number evaluated: 40 (FMS: 21; control: 19), 8 dropouts (FMS: 3; control: 5) (Quote: "Subsequently, eight more patients were excluded from the study for various reasons") |
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Interventions |
Comparison: FMS vs control FMS group: (FMRP) 2 sessions within 24 hours Control group: QRP 4 sessions at 1‐week intervals OHI before study start: yes Instruments used: hand and US instruments Time per Q: unclear Maintenance: none Retreatment: none Duration of study: 3 months |
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Outcomes |
Primary outcome: unclear* Secondary outcomes: unclear* Teeth: whole‐mouth recordings (baseline, 1 and 3 months). Data split in initial moderate (PPD 5–7 mm) and deep pockets (PPD ≥ 7 mm). Williams manual probe Pocket depth at baseline: moderate (5 to < 7 mm), deep (≥ 7 mm) Outcome time reported: 3 months data used; 1 and 3 months measured Other outcomes: *PPD, CAL, BOP, PI, GI, PBI (4 sites per tooth), body temperature |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation performed with a computer‐generated list. |
Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomised into two groups according to a computer‐generated list provided by a person not involved in the study". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All the measurements have been conducted by the same investigator blind to the therapeutic protocol applied". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Time point of dropout for each of the 8 participants unclear. |
Selective reporting (reporting bias) | Low risk | All parameters have been reported. |
Other bias | Low risk | Baseline balance good. |