Babaloo 2018.
Study characteristics | ||
Methods |
Study design: RCT with 2‐arm parallel design Recruitment period: unclear Setting: University Dental Hospital, Iran Number of centres: 1 Funding source: none |
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Participants |
Inclusion criteria: diagnosis: chronic periodontitis with ≥ 12 teeth Exclusion criteria: systemic disease or on antibiotics from 2 months before or during study Age: 25–70 years (mean: FMD: 43 (SD 12.47) years; control: 47.7 (SD 9.4))* Sex: 19 F (FMD: 11; control: 8) and 21 M (FMD: 9; control 12)* Smokers: unknown Number randomised: 40 (20 per group)* Number evaluated: 40 (20 per group)* (implied but not explicitly stated) |
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Interventions |
Comparison: FMD vs control FMD group: US instrumentation in 2 sessions within 24 hours, subgingival: CHX 0.2%; tongue brushing: CHX 0.2%; rinse: CHX 0.2% Control group: (Q‐SRP) QRP 4 sessions – 2‐weekly intervals, type of instruments unknown OHI before study start: unknown Instruments used: US instruments, unknown if hand instruments were used Time per Q: unknown Maintenance: at week 2, 4, 8, 12 and 16 after treatment (both groups), PI recorded, OHI given Retreatment: none Duration of study: 4 months |
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Outcomes |
Primary outcome: unknown Secondary outcomes: PPD, CAL, BOP (4 sites per tooth), serum IL‐27 (see Shirmohammadi 2013 under Babaloo 2018; also serum IL‐17 And IL‐1β were evaluated) Teeth: whole‐mouth recordings with manual probe Pocket depth at baseline: data not split for pocket depth categories Outcome time reported: 4‐month data used. Baseline, 2 and 4 months reported Other outcomes: PI, MGI* |
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Notes | *additional information found in Shirmohammadi 2013 under Babaloo 2018. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to two groups using toss of a coin". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information for judgement. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All the measurements were performed by one calibrated periodontist who was blind to the treatment groups" (additional information from Shirmohammadi 2013 under Babaloo 2018). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information for judgement. It is implied that all participants completed the study but not explicitly stated. |
Selective reporting (reporting bias) | Low risk | Data reported on secondary outcomes; primary outcome not defined. |
Other bias | Unclear risk | Baseline balance good for pocket depth; however smoking unclear. No apparent other biases. |