Camargo 2009.
Methods | Trial design: randomised, split‐mouth trial Location: School of Dentistry, University of Belgrade, Belgrade, Republic of Serbia Number of centres: 1 Recruitment period: 15 May 1999 to 20 March 2000 Source of funding: not stated Ethical approval: yes, University Institutional Review Board Number of surgeons: 2 |
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Participants | Inclusion criteria: patients having 2 similar interproximal defects with PD > 6 mm after initial therapy. Radiographic evidence of intrabony defects had to exist. Upon surgical exposure, defects needed to have a minimum depth of 3 mm and present with 2 or 3 walled defects
Exclusion criteria: systemic illnesses, compromised immune system, pregnant and/or lactating women, and patients taking any drug known to cause gingival enlargement. Patients allergic or sensitive to any of the medications to be used, teeth non‐responsive to cold or endodontically treated
Age at baseline: 34 to 67 years (mean age = 47 ± 10 years) Gender: F 14/M 9 Smokers: 11 smokers/12 non‐smokers Teeth treated: maxillary and mandibular posteriors Number randomised (participants/teeth): 23/46 Number evaluated (participants/teeth): 23/46 |
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Interventions | Comparison: PRP/BPBM/GTR versus BPBM/GTR Test group: PRP/BPBM/GTR (n = 23) Control group: BPBM/GTR (n = 23) Surgical technique: intrabony defects treated with PRP/BPBM/GTR for test group and BPBM/GTR for control group Follow‐up duration: 6 months |
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Outcomes | Clinical: PD, CAL, defect fill (re‐entry surgery) Radiographic: none Other: alveolar crest resorption |
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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: "The study used a split‐mouth design, and 2 interproximal sites were randomly (toss of a coin) assigned to the control and experimental groups" Comment: correct method for random sequence generation |
Allocation concealment (selection bias) | Low risk | Quote: "The study used a split‐mouth design, and 2 interproximal sites were randomly (toss of a coin) assigned to the control and experimental groups" Comment: correct method for allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Impossible to blind the operator given the surgical nature of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "An examiner other than the surgeons performed all clinical measurements without knowledge of the treatment groups" Comment: blinding of outcome assessment done properly |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised patients completed the study |
Selective reporting (reporting bias) | Low risk | Data for outcomes of this review were reported appropriately |