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 |
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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) |
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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 |
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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 |
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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. |
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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. |