Hanna 2004.
Methods | Trial design: randomised, split‐mouth, double‐blinded trial Location: The University of Texas Health Science Center at Houston, Texas, USA Number of centres: 1 Recruitment period: not reported Source of funding: not stated Ethical approval: yes, Committee for the Protection of Human Subjects at the University of Texas Health Science Center at Houston, Texas, USA Number of surgeons: 1 |
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Participants | Inclusion criteria: patients between 35 to 75 years of age; exhibited plaque score of 20% or less prior to the surgical phase; teeth with mobility less than Miller's Class III or mobile teeth requiring splinting; and teeth responding normally to vitality testing or with stable endodontic therapy Exclusion criteria: known systemic diseases and/or drug therapy known to interfere with wound healing; known drug allergies to any of the medications used in the study; using systemic antibiotics or having received antibiotic therapy in the last 3 months; abnormal platelet counts disclosed by a complete blood count (CBC) test performed within 1 month prior to surgery; and participation in other dental clinical trials Age at baseline: 37 to 74 years Gender: F 8/M 5 Smokers: yes, 1 heavy smoker (> 20 cigarettes/day) Number randomised (participants/teeth): 13/26 Number evaluated (participants/teeth): 13/26 | |
Interventions | Comparison: BDX + PRP versus BDX alone Test group: BDX + PRP (n = 13 defects) Control group: BDX alone (n = 13 defects) Surgical technique: OFD + intrabony defects treated with BDX alone in control group and additionally PRP was applied in test group Follow‐up duration: 6 months |
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Outcomes | Clinical: GI, PI, PD, CAL, recession as the position of the gingival margin from the CEJ, and BOP Radiographic: none reported Other: none |
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Notes | Sample size calculation: not reported Comparability at baseline: yes, assessed Complications reported: yes Dropouts: reported, no dropouts |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed immediately following defect debridement by the flip of a coin" Comment: correct method for random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was performed immediately following defect debridement by the flip of a coin" Comment: not sufficient information provided regarding the method of allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Impossible to blind the operator due to the surgical nature of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "13 patients were enrolled in a randomized, split‐mouth, double‐masked clinical trial" Comment: blinding of outcomes likely to have been done properly |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised patients completed the study |
Selective reporting (reporting bias) | Low risk | All outcomes properly reported |