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

Mongardini 1999.

Study characteristics
Methods Study design: RCT with 2‐arm parallel design
Recruitment period: unclear
Setting: university dental hospital, Belgium
Number of centres: 1
Funding source: supported by university
Participants Inclusion criteria: diagnosis of chronic periodontitis with PD ≥ 7 mm and BOP (people with aggressive periodontitis also included). All participants in good general health
Exclusion criteria: antibiotics from 4 months before or during study, smokers
Age: 23–69 years (based on all 40)
Sex: 9 F (FMD: 7; control: 2), 15 M (FMD: 5; control 10)
Smokers: 8 (FMD: 3; control: 5) (smoking ≥ 10 cigarettes per day)
Number randomised: 24 (40 including aggressive periodontitis)
Number evaluated: 24 (12 per group)
Interventions Comparison: FMD vs control*
FMD group: 2 sessions within 24 hours, after instrumentation; tongue brushing: CHX 1%, 1 minute; rinse: CHX 0.2%, 1 minute; spray pharynx: CHX 0.2%; subgingival: CHX 1%, 3 times within 10 minutes, repeat subgingival after 8 days. Home: rinse CHX 0.2%, 1 minute, 2 × day, 2 months; spray: CHX 0.2%, 2 × day, 2 months
Control group: SRP 4 sessions 2‐weekly intervals
OHI before study start: no
Instruments used: hand instruments
Time per Q: unclear
Maintenance: after 1, 2 and 4 months
Retreatment: none
Duration of study: 8 months
Outcomes Primary outcome: PPD (4 sites per tooth)
Secondary outcomes: CAL, BOP (4 sites per tooth). Manual probe for all measurements
Teeth: only recording of first Q. Data split in single‐/multi‐rooted teeth and initial moderate (PPD 4.5–6.5 mm) and deep pockets (PPD ≥ 7 mm)
Pocket depth at baseline: moderate (PPD 4.5–6.5 mm) and deep pockets (PPD ≥ 7 mm)
Outcome time reported: 4 and 8 months used, 1, 2, 4 and 8 months measured
Other outcomes: SBI, plaque extent, pain and swelling on VAS, number of analgesics, occurrence of herpes labialis or oral ulcers
Notes Only data from participants with chronic periodontitis were included in the meta‐analysis.
*The follow‐up paper Quirynen 2000 involved a third group that was not randomised.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…the participants signed an informed consent form and were randomly distributed between test and control groups by coin toss…".
Allocation concealment (selection bias) Unclear risk Unclear.
Blinding of outcome assessment (detection bias)
All outcomes High risk The same person (CM) performed treatment and examination.
Quote: "The sessions of scaling and root planing (SRP) were performed under local anaesthesia by the same investigator (CM)…" "…clinical parameters…were recorded by the same periodontist (CM)".
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 and smoking. No apparent other biases.