Quirynen 2006.
Study characteristics | ||
Methods |
Study design: RCT with 5‐arm parallel design (3 arms included) Recruitment period: unclear Setting: university dental hospital, Belgium Number of centres: 1 Funding source: supported by University |
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Participants |
Inclusion criteria: diagnosis of chronic periodontitis with PD ≥ 6 mm. All participants in good general health Exclusion criteria: SRP in past 12 months or antibiotics from 4 months before or during study, compromised medical condition, pregnancy Age: 31–75 years. All Caucasian (assumed to be white people) Sex: 19 F (FMS: 10; FMD: 4; control: 5) and 24 M (FMS: 4; FMD: 10; control: 10) Smokers: 11 (FMS: 3; FMD: 3; control: 5) Number randomised: 85 in 5 arms Number evaluated: 43 in 3 arms (FMS: 14; FMD: 14; control: 15) (71 in 5 arms) |
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Interventions |
Comparison: FMS vs control; FMD vs control; FMS vs FMD FMS group: (FRp): FMS 2 sessions over within 24 hours FMD group: (FM‐CHX): 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. Home: rinse CHX 0.2%, 1 minute, 2 × day, 2 months Control group: (NC): QRP 4 sessions scaling – 2‐week intervals, no antiseptics Groups not used in the review: 2 arms that were variations of the FMD intervention, i.e. amine fluoride/stannous fluoride for 2 months after full‐mouth scaling or chlorhexidine for the first 2 months followed by amine fluoride/stannous fluoride for another 6 months. OHI before study start: no Instruments used: hand instruments Time per Q: unclear Maintenance: 1, 2 and 4 months Retreatment: none Duration of study: 8 months |
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Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: CAL (as sum of PPD and GR), BOP (6 sites per tooth). Manual probe for all measurements Teeth: first Q recordings (baseline, 2, 4 and 8 months). Data split in single‐/multi‐rooted teeth and initial medium (PPD 4–5.5 mm) and deep pockets (PPD > 5 mm) Pocket depth at baseline: moderate (PPD 4.5–6.5 mm) and deep pockets (PPD ≥ 7 mm) Outcome time reported: 8 months used, 1, 2, 4* and 8 months measured Other outcomes: SBI, PI, GR (6 sites per tooth) |
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Notes | Dropouts: 85 enrolled, 71 completed the study. Time point for dropouts unclear. Only 3 arms of trial included. *Authors could not provide data for 4 months evaluation on request. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A clinician who was informed about the baseline clinical data (but not about the content of the treatment strategies) randomly allocated (via a random‐number table) the consecutive participants (if fulfilling criteria) to one of the following groups". |
Allocation concealment (selection bias) | Low risk | Quote: "A clinician who was informed about the baseline clinical data (but not about the content of the treatment strategies) randomly allocated (via a random‐number table) the consecutive participants (if fulfilling criteria) to one of the following groups". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Treatment and examination by 2 independent people. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts 14/85; unclear reasons or timing of dropouts. |
Selective reporting (reporting bias) | Low risk | Data reported on all primary and secondary outcomes. |
Other bias | Low risk | Baseline balance good for pocket depth and smoking. No apparent other biases. |