Del Peloso 2008.
| Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: July 2005 ‐ June 2006 Setting: University Dental Hospital, Brazil Number of centres: One Funding source: Unclear |
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| Participants |
Inclusion criteria: Diagnosis: Severe chronic periodontitis ‐ with PD of > 5mm and BOP positive Exclusion criteria: Medical disorders, SRP in past 6 months or on antibiotics from 6 months before or during study, smokers, pregnancy Age: 30 to 66 Gender: 18 F (9/9) and 7 M (4/3) Smokers: 0 Number randomised: 25 (?/?) Number evaluated: 25 (13/12) |
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| Interventions |
Comparison: FMS vs control Test group: (FMS) One session within 45 minutes Control group: (SRP): QRP 4 sessions at 1‐week intervals OHI before study start: Yes Instruments used: Hand and US instruments Time per Q: 45 minutes for test group Maintenance: Every month Retreatment: After 3 months (PPD ≥ 5 mm) Duration of study: 6 months |
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| Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: RAL, BOP (6 sites per tooth) Teeth: Whole‐mouth recordings with manual probe, moderate and severe PD at baseline Pocket depth at baseline: Moderate (5 and 6 mm), deep (> 7 mm) (authors' information). Manual probe with stent Outcome time reported: 3 months used, 6 months also reported. Other outcomes: Plaque score, Gingival Bleeding Index, recession (6 sites per tooth), body temperature, VAS scales for patient, visual plaque index after initial prophylaxis, 30% in test and 40% in control group |
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| Notes | Starting quadrant of SRP unclear On request only BOP for sites > 4 mm; not for subgroups |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised into two groups according to a computer‐generated list" |
| Allocation concealment (selection bias) | Low risk | Quote: "The allocation concealment was secured by having a person not involved in the study performing the randomisation. This person was different from the one responsible for the treatment (S. B.) and different from the examiner (E. D. P. R.). The randomisation code was not broken until all data had been collected. Thus, the treatment group was not revealed to the clinical examiner or to the statistician" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Treatment and examination by two independent persons |
| 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 |