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

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
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")
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
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
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.