Skip to main content
. 2022 Jun 28;2022(6):CD004622. doi: 10.1002/14651858.CD004622.pub4

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)
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)
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
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)
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.