Skip to main content
. 2022 Jun 28;2022(6):CD004622. doi: 10.1002/14651858.CD004622.pub4

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
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)
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
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
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.