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. 2022 Jun 28;2022(6):CD004622. doi: 10.1002/14651858.CD004622.pub4

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
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)
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
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)
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.
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.