Afacan 2020.
Study characteristics | ||
Methods |
Study design: RCT with 3‐arm parallel design Recruitment period: October 2006–May 2008 Setting: University Dental Hospital, Turkey Number of centres: 1 Funding source: The Scientific and Technological Research Council of Turkey, grant/award number 106S212 |
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Participants |
Inclusion criteria: diagnosis of chronic periodontitis with PPD ≥ 6 mm Exclusion criteria: systemic disease or on antibiotics from 6 months before or during study Age: 35–60 years Sex: 24 F (FMD: 8; FMS: 7; control: 9), 36 M (FMD: 12; FMS: 13; control: 11) Smokers: 0 Number randomised: 68 (FMD: 23; FMS: 22; control: 23) Number evaluated: 60 (FMD: 20; FMS: 20; control: 20) |
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Interventions |
Comparison: FMD vs control; FMS vs control; FMD vs FMS FMD group: FMD US instrumentation in 2 sessions within 24 hours, after instrumentation: tongue brushing: CHX 1%, 1 minute; rinse: CHX 0.2%, 2 × 1 minute; spray pharynx: CHX 0.2%; subgingival: CHX 1%, 3 × within 10 minutes, repeated at day 8. Home: rinse CHX 0.2%, 1 minute, 2 × day; spray tonsils: CHX 0.2%, 2 × day, 2 weeks FMS group: (FMUD) US instrumentation in 2 sessions within 24 hours Control group: (QRP) 4 sessions – 1‐weekly intervals, start 1 Q, hand instruments OHI before study start: no Instruments used: hand and US instruments Time per Q: unknown Maintenance: at 1, 3 and 6 months from last instrumentation Retreatment: none Duration of study: 6 months |
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Outcomes |
Primary outcome: change in GCF biomarker levels Secondary outcomes: PPD, CAL (6 sites per tooth), changes of percentage of pockets with initial PD ≥ 5 mm, changes periodontal pathogen levels Teeth: whole‐mouth recordings with manual probe Pocket depth at baseline: sampling sites (GCF) ≥ 6 mm for selected sites Outcome time reported: 3‐ and 6‐month data used. Baseline, 1, 3 and 6 months measured Other outcomes: PI, PBI, number of single‐rooted teeth, tooth loss, any harm after treatment |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Study co‐ordinator randomly allocated participants into 3 groups using a computer‐generated randomisation list. |
Allocation concealment (selection bias) | Unclear risk | Unknown; operator and examiner was the same person. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Clinical measurements, GCF, plaque sampling and all treatments were performed by the same trained investigator in a standardised way. Comment: the same person undertook the interventions and the outcome assessments. |
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. |