Swierkot 2009.
Methods |
Study design: RCT with 3‐arm parallel design Recruitment period: Unclear Setting: University Dental Department, Marburg, Germany Number of centres: One Funding Source: Supported by University |
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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: antibiotics from 6 months before or during study, history of systemic disease, orthodontic patients, pregnancy Age: 28 to 63 years Gender: 20 F (FMS/FMD/control 7/7/6) and 5 M (2/2/1) Smokers: 5 (3/1/1) (smoking at least 10 cigarettes per day) Number randomised: 25 (9/9/7) Number evaluated: 25 (9/9/7) |
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Interventions |
Comparison: FMS vs control: FMD vs control: FMS vs FMD Test group 1: (FM‐SRP): 2 sessions within 24 hours Test group 2: (FMD): 2 sessions scaling within 24 hours; after instrumentation: tongue brushing: CHX = 1%, 1 min; rinse: CHX = 0.2%, twice for 1 min; spray pharynx: CHX = 0.2% 4 x each, subgingival: CHX = 1%. Home: rinse CHX = 0.2%, 1 min, 2 x day, 14 days; spray tonsils: CHX = 0.2%, 1 x day, 14 days Control group: (Q‐SRP): 4 sessions quadrant wise, 1 week interval starting first quadrant, hand and US instruments OHI before study start: Yes Instruments used: Hand and US instruments Time per Q: Unclear Maintenance: 1, 2, 4 and 8 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: Whole‐mouth recordings (baseline, 1, 2, 4, and 8 months). Data split in single‐ and multi‐rooted teeth for moderate (4 ‐ 6 mm) pockets and whole‐mouth recordings for deep ( ≥ 7 mm) pockets Pocket depth at baseline: moderate (PPD 4 ‐ 6 mm) and deep pockets (PPD > 7 mm) Outcome time reported: 4 months used. 1, 2, 4, 8 months measured. Other outcomes: PLI, API, microbiology |
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Notes | Blinding unclear. Exclusion of third molars, as well as teeth with furcation degree II and III | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomisation was performed with a combination of coin toss and drawing of lots by a second person not involved in the study to assign the patients into the following groups: full mouth disinfection (FMD), FM‐SRP and Q‐SRP". |
Allocation concealment (selection bias) | Low risk | "The sequence was concealed until interventions were assigned". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "One patient in every group was excluded from the study due to prescribed antibiotics because of sinusitis maxillaris. The patient of the FM‐SRP group dropped out 2 months after treatment and the two patients of the other two groups dropped out 4 months after treatment. Their data were not included into the statistical analysis". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "The treatment and reassessment were performed by one periodontist who had been trained and tested previously for his reproducibility". |
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. |