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. |
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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) |
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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 |
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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 |
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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. |