Jervøe‐Storm 2006.
| Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: Setting: University Dental Hospital, Bonn, Germany Number of centres: One Funding source: Unclear |
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| Participants |
Inclusion criteria: Diagnosis: Chronic periodontitis ‐ with PD of > 5 mm and BOP positive. All patients were in good general health Exclusion criteria: SRP in past 6 months or on antibiotics from 6 months before or during study, pregnancy Age: 53.1 +/‐ 10.2 Gender: 11 F (5/6) and 9 M (5/4) Smokers: 2 (1 in each group) (smoking at least 10 cigarettes per day) Number randomised: 20 Number evaluated: 20 (10/10) all Caucasian |
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| Interventions |
Comparison: FMS vs control Test group: (FM‐RP): FMS 2 sessions within 24 hours on 2 consecutive days Control group: (QRP): QRP 4 sessions ‐ 1‐week intervals OHI before study start: yes Instruments used: Hand and US instruments Time per Q: 1 hour Maintenance: Every month after 3 months Retreatment: None Duration of study: 6 months |
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| Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: RAL, BOP (only for PPD > 4 mm) (6 sites per tooth) Teeth: Whole‐mouth recordings with computer‐assisted probe with stent for all measurements, moderate and severe PD at baseline Pocket depth at baseline: Moderate (> 5 ‐ < 7 mm), deep (> 7 mm) Outcome time reported: 3 months used, 6 months also reported Other outcomes: Data from first quadrant |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomised into two groups according to a computer generated list provided by an external agent" |
| Allocation concealment (selection bias) | Low risk | Not mentioned in report of trial but author states "treatment was concealed for all participants until first intervention. The randomisation was first made, when the patient was sitting in the office and treatment began. An independent person gave the treatment‐mode to the therapist" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All measurements were performed by one blinded examiner" |
| Selective reporting (reporting bias) | Low risk | Data reported on all primary and secondary outcomes |
| Other bias | Low risk | Baseline balance good for pocket depth. No apparent other biases |