Agarwal 2014.
Methods | Trial design: randomised, split‐mouth trial Location: Aligarh, India Number of centres: 1: Department of Periodontics, Dental College, Aligarh, India Recruitment period: not stated Source of funding: not stated Ethical approval: yes, ethical committee of Aligarh Muslim University Number of surgeons: 1 |
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Participants | Inclusion criteria: absence of any systemic disease, not taking any medication, no pregnancy or lactation, non‐smokers, no previous treatment for periodontal reasons, no furcation involved, matched pairs of intrabony defects with PD ≥ 6 mm following initial therapy Exclusion criteria: failure to satisfy inclusion criteria Age at baseline: mean not specified, range 30 to 65 years Gender: F 10/M 14 Smokers: excluded Teeth treated: maxillary/mandibular premolars and first/second molars Number randomised (participants/teeth): 24/48 Number evaluated (participants/teeth): 24/48 | |
Interventions | Comparison: PRP + DFDBA versus DFDBA + saline solution Test group: PRP + DFDBA (n = 24 defects) Control group : DFDBA + saline (n = 24 defects) Surgical technique: OFD with the adjunct of a graft with DFDBA + PRP in test and saline in control Follow‐up duration: 12 months |
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Outcomes | Clinical: PD, CAL Radiographic: CEJ‐AC, AC‐BD, CEJ‐BD, defect width |
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Notes | Sample size calculation not reported Radiographs were taken with a bite block for ensuring reproducibility Comparability at baseline: yes, but not specified if it was assessed Complications reported: yes (no complications) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "defects were randomly divided into 2 groups by the flip of a coin" Comment: correct method for random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote: "defects were randomly divided into 2 groups by the flip of a coin" Comment: not sufficient information provided for allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Impossible to blind the clinician given the surgical nature of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Clinical parameters were recorded preoperatively and at 12 months postoperatively by one trained examiner who was blind to the treatment assignments. Radiographs were assessed on a light box by a single experienced clinician who was blind to the treatment used" Comment: blinding likely to have been done properly |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the analyses |
Selective reporting (reporting bias) | Low risk | Data for outcomes of this review were reported appropriately |