Wennström 2005.
Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: during 2002 Setting: University Dental Hospital (Sweden), private dental office (Italy) Number of centres: Two Funding Source: Industry funding |
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Participants |
Inclusion criteria: Diagnosis: Chronic periodontitis‐ with PD of > 5 mm and BOP. All patients were in good general health Exclusion criteria: SRP over last 12 months, antibiotics from 3 months before or during study, pregnant Age: 25 to 75 Gender: 19 F (8/11) and 22 M (12/10) Smokers: 20 (9/11) Number randomised: 42 Number evaluated: 41 (20/21) |
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Interventions |
Comparison: FMS vs control Test group: (FM‐UD‐test): FMS 1‐h session ultrasonic scaling with water, re‐instrumentation after 3 months in PPD > 4 mm. Control group: (Q‐SRP‐control): QRP 4 sessions hand instrumentation ‐ 1‐week intervals (time recorded, no time restriction), re‐instrumentation after 3 months in PPD > 4 mm OHI before study start: yes Instruments used: Hand and US instruments Time per Q: 1 hour Maintenance: 1 month following completion of instrumentation (both groups) Retreatment: at 3 months Duration of study: 6 months |
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Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: CAL, BOP (6 sites per tooth). Manual probe for all measurements Teeth: Whole‐mouth recordings (baseline, 3 and 6 months). Data split in initial moderate (PPD 5 to 6 mm) and deep pockets (PPD > 6 mm) Pocket depth at baseline: moderate (PPD 5‐6 mm) and deep pockets (PPD > 7 mm) Outcome time reported: 3 months used. 3 and 6 months measured. Other outcomes: PI, Average pain VAS score (100 mm scale) |
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Notes | For BOP: Data supplemented by authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Within each of these subgroups, a random assignment to the two treatment protocols (Fig. 1) was subsequently performed by the use of computer‐generated tables". |
Allocation concealment (selection bias) | Low risk | "Allocation concealment was secured by (i) having a person not otherwise involved in the study performing the randomisation and (ii) providing the centres (the dental hygienists) with sealed envelopes containing only the assignment for the individual subject" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 42 enrolled, 41 randomised, and 41 present at 6 months. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "One examiner (a periodontist), who was masked with respect to the treatment assignments, performed all examinations". |
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. |