Zijnge 2010.
Study characteristics | ||
Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: September 2007–December 2008 Setting: private clinic, Groningen, The Netherlands Number of centres: 1 Funding source: university funding |
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Participants |
Inclusion criteria: diagnosis of chronic periodontitis with PD ≥ 6 mm at > 10% sites. All participants in good general health Exclusion criteria: SRP over last 5 years, antibiotics from 3 months before or during study, pregnant, smokers, removable denture Age: 25–75 years Gender: 16 F (8 per group) and 22 M (FMS: 10; control: 12) Smokers: 0 Number randomised: 39 (FMS: 19; control: 20) Number evaluated: 38 (FMS 18; control: 20) |
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Interventions |
Comparison: FMS vs control FMS group: (FM‐SRP) 1 × 3‐hour session Control group: (MS‐SRP): 3 sessions Q‐wise, 1‐hour duration per session, 10‐week interval starting first Q, hand instruments OHI before study start: no Instruments used: hand instruments Time per Q: 1 hour Maintenance: 1 and 2 weeks Retreatment: none Duration of study: 3 months |
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Outcomes |
Primary outcome: PPD (6 sites per tooth) Secondary outcomes: BOP (6 sites per tooth). Manual probe for all measurements Teeth: whole‐mouth recordings as well as test‐Q (1st Q). Data split in moderate (4–6 mm) and deep (≥ 7 mm) pockets Pocket depth at baseline: moderate (PPD 4–6 mm) and deep pockets (PPD ≥ 7 mm) Outcome time reported: 3 months Other outcomes: PI, microbiology |
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Notes | PI at baseline unclear Pockets < 3 mm were not recorded. No data for CAL on request. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a second independent person informed them whether they had to continue the treatment in the other quadrants (FM‐SRP) or continue treatment in another session (MS‐SRP), based on a computer‐generated randomisation table". |
Allocation concealment (selection bias) | Low risk | Quote: "All study personnel was blinded to treatment assignment for the duration of the study". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "After 3 months the patients were examined by a periodontist. All study personnel was blinded to treatment assignment for the duration of the study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 44 attended baseline examination but unclear if they were randomised. 1 participant dropped out of FMS group. Probably low risk of bias. |
Selective reporting (reporting bias) | Low risk | Data reported on all outcomes. |
Other bias | Low risk | Baseline balance good for pocket depth. No apparent other biases. |
API: Approximal Plaque Index; AZ: azithromycin; BOP: bleeding on probing; CAL: clinical attachment level; CHX: chlorhexidine gluconate; DAS: Dental Anxiety Scale; DFS: Dental Fear Scale; F: female; FC: FMD with CHX; FM‐CHX: FMD with CHX; FM‐RP: see FMS; FM‐UD: FMS with ultrasonic instrumentation; FMD: full‐mouth disinfection (full‐mouth subgingival scaling and root planing with use of antiseptics); FM‐SRP: full‐mouth scaling and root planing; FMRP: FMS; FMS: full‐mouth scaling (full‐mouth subgingival scaling and root planing); FNC: FMD without CHX; FRp: FMS; GBI: Gingival Bleeding Index; GCF: gingival crevicular fluid; GI: Gingival Index (Löe 1963); GR: gingival recession; IL: interleukin; M: male; MGI: modified Gingival Index; MS‐SRP: multiple session scaling and root planing; NC: see QRP; OHI: oral hygiene instruction; PAL: probing attachment level; PBI: Papilla Bleeding Index; PD: probing depth; PD‐PIG: see FMD; PDG: see FMS; PI: Plaque Index (O'Leary 1972); PLI: Plaque Index (Silness 1964); PPD: probing pocket depth; PTQ‐TS: see QRP; PTSS: full‐mouth periodontal therapy; Q: quadrant; Q‐SRP: see QRP; QRP: quadrant‐wise subgingival scaling and root planing, clockwise in 4 sessions; RAL: relative attachment level; RCT: randomised controlled trial; SBI: Sulcus Bleeding Index; SD: standard deviation; SI: Staining Index; SRP: scaling and root planing; SRP‐Q: see QRP; SUP: suppuration; UNC: University of North Carolina; US: ultrasonic; VAS: visual analogue scale; VPI: Visible Plaque Index; VSC: volatile sulphuric compound; WTCI: Winkel Tongue Coating Index.