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

Graziani 2015.

Study characteristics
Methods Study design: RCT with 2‐arm parallel design
Recruitment period: July 2012–July 2013
Setting: university dental hospital, Pisa, Italy
Number of centres: 1
Funding source: Unit of Dentistry and Oral Surgery of the University of Pisa and by the Italian Ministry Health and the Tuscan Region (Grant # GR‐2009‐1592229). FD holds a Clinical Senior Lectureship Award supported by the UK Clinical Research Collaboration. MO holds a UCL Impact Award partially supported with a fellowship grant by Johnson and Johnson Consumer Services EAME Limited. FD and MO work at UCL, which received a proportion of funding from the Department of Health's National Institute of Health Research (NIHR) Biomedical Research Centres funding scheme.
Participants Inclusion criteria: diagnosis of chronic periodontitis*
Exclusion criteria: medical disorders, SRP in past 6 months or on antibiotics from 3 months before or during study, smokers, pregnancy
Age: FMS: 46 (SD 12) years; control: 48 (SD 9) years
Sex: 19 F (FMS: 9; control: 10) and 19 M (FMS: 10; control: 9)
Smokers: FMS: 7; control: 6
Number randomised: 38 (19 per group), all 'Caucasian'
Number evaluated: 38 (19 per group)
Interventions Comparison: FMS vs control
FMS group: 2 session within 24 hours
Control group: (SRP) 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: CRP increase
Secondary outcomes: changes in a broad array of inflammatory and endothelial injury markers
Teeth: whole‐mouth recordings with UNC‐15 manual probe
Pocket depth at baseline: PPD > 4 mm
Outcome time reported: 3 months used
Other outcomes: PPD, CAL, BOP, PI (6 sites per tooth), body temperature
Notes *Diagnosis provided by corresponding author on request.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated table.
Allocation concealment (selection bias) Low risk Quote: "Allocation to treatment was concealed to the clinical examiner and statistician with opaque envelopes which were opened by the clinician on the day of treatment".
Blinding of outcome assessment (detection bias)
All outcomes Low risk Examination by a blinded calibrated examiner, treatment by a single periodontist.
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.