Fonseca 2015.
Study characteristics | ||
Methods |
Study design: RCT with 6‐arm parallel design (3 arms included) Recruitment period: 2011–2012 Setting: University Dental Hospital, Brazil Number of centres: 1 Funding source: Productivity Research fellows (PQ) and the National Program of Academic Cooperation (PROCAD) grant 552264/2011‐3 from National Council of Scientific and Technological Development (CNPq), Brasilia, Brazil (to FOC) |
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Participants |
Inclusion criteria: diagnosis of chronic periodontitis Exclusion criteria: systemic disease or on antibiotics from 3 months before or during study Age: 35–60 years Sex: 52 F (grouping unknown), 33 M (grouping unknown) Smokers: 72 non‐smokers, 13 smokers, grouping unknown Number randomised: 90 (15 in each of 6 groups) Number evaluated: 85 (groups included in review – FMD: 15; FMS: 15; control: 13) |
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Interventions |
Comparison: FMD vs control; FMS vs control; FMD vs FMS FMD group: (FC) hand instrumentation in 2 sessions within 24 hours, 60 minutes per session, for 2 consecutive days, after instrumentation: subgingival CHX 1%; tongue brushing: CHX 1%, 1 minute; rinse: CHX 0.12%, 30 seconds, last 10 seconds involving gargling, 2 × per session. Home: rinse: CHX 0.12%, 2 × day, 2 weeks FMS group: (FNC): hand instrumentation within 24 hours in 2 sessions, 60 minutes each session, for 2 consecutive days Control group: (QSNC) QRP 4 sessions, 1‐weekly intervals, hand instruments, 30 minutes for each Q Groups not used in the review: FMD using AZ; SRP plus AZ; SRP plus CHX OHI before study start: unknown Instruments used: hand instruments Time per Q: 30 minutes Maintenance: none reported Retreatment: none Duration of study: 6 months |
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Outcomes |
Primary outcome: PPD (6 sites per tooth). PPD used for whole mouth as well as for pocket categories Secondary outcomes: CAL (6 sites per tooth), changes total bacterial counts. CAL used for whole‐mouth recordings* Teeth: whole‐mouth recordings with manual probe Pocket depth at baseline: 4 mm and 5 mm, ≥ 6 mm Outcome time reported: 3‐ and 6‐month data used. Baseline, 3 and 6 months measured Other outcomes: *changes in baseline CAL 3–4 mm and ≥ 5 mm (not used, does not correspond the PPD sites) |
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Notes | Quote: "The groups were homogeneous in regard to sex, age, and smoking status (P >0.05)". | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised into groups according to opaque envelopes. |
Allocation concealment (selection bias) | Low risk | Quote: "Ninety opaque envelopes containing the groups' therapy identifications were sealed, mixed, and numbered sequentially". Envelopes "were opened by a masked researcher (LOMC)". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Examiners (FOC and JRC) were masked to the intervention group", "Treatment procedures were performed by four experienced periodontists (DCF, SCC, LCMC, and MVMC) masked to the adjuvant groups." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropout of 2 participants in the control group before 3‐month examination for unclear reasons. |
Selective reporting (reporting bias) | Low risk | Data reported on all primary and secondary outcomes. |
Other bias | Unclear risk | Baseline balance good for pocket depth, however smoking unclear. No apparent other biases. |