Roman‐Torres 2018.
| Study characteristics | ||
| Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: 2010–2014 Setting: university dental hospital, Brazil Number of centres: 1 Funding source: unknown |
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| Participants |
Inclusion criteria: diagnosis of chronic periodontitis. All participants in good general health Exclusion criteria: SRP in past 12 months or antibiotics 6 months before or during study, pregnancy, smokers, orthodontic therapy Age: 41–60 years Sex: 138 F (FMD: 63; control: 75) and 92 M (FMD 52; control: 40) Smokers: none Number randomised: 230 Number evaluated: 230 (115 per group) |
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| Interventions |
Comparison: FMD vs control FMD group: FMS 2 sessions scaling within 24 hours. Home: rinse CHX 0.12%, 1 minute, 1 × day, 1 week Control group: SRP 4 sessions 1‐week interval OHI before study start: yes Instruments used: hand instruments Time per Q: unknown Maintenance: FMD: OHI in both sessions, QRP: OHI in 1st and last session. OHI in both groups at 3 months examination Retreatment: none Duration of study: 3 months |
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| Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: CAL (6 sites per tooth). Manual probe for all measurements Teeth: whole‐mouth recordings Pocket depth at baseline: data not split for pocket depth categories Outcome time reported: 3‐month data Other outcomes: GI, PI (4 sites per tooth), microbiological changes in deep pockets (depth unknown) (Prevotella intermedia, Porphyromonas gingivalis) by cultivation |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation unclear. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information for judgement. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information for judgement. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All included participants completed study. |
| Selective reporting (reporting bias) | Low risk | All data reported. |
| Other bias | Unclear risk | Insufficient information for judgement. |