Sharma 2011.
| Methods | Trial design: randomised, parallel trial Location: Department of Periodontics, Government Dental College and Research Institute, Bangalore, India Number of centres: 1 Recruitment period: June 2009 to March 2010 Source of funding: nil Ethical approval: Institutional Ethical Committee and Review Board, Government Dental College and Research Institute, Bangalore, India Number of surgeons: 1 |
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| Participants | Inclusion criteria: presence of 3‐walled intrabony defects > 3 mm deep (the distance between the alveolar crest and base of the defect on an intraoral periapical radiograph (IOPA)) along with an interproximal PD > 5 mm after phase 1 therapy (scaling and root planing) in an asymptomatic tooth
Exclusion criteria: patients with aggressive periodontitis with known systemic illness and taking any medications known to affect the outcomes of periodontal therapy; an insufficient platelet count (< 200,000/mm3); pregnancy or lactation; use of any form of tobacco; patients who had unacceptable oral hygiene (PI > 1.5) after the re‐evaluation of phase 1 therapy; teeth with furcation defects, non‐vital teeth or teeth with mobility > grade II
Age at baseline: 30 to 50 years; mean = 35.34 + 6.45 years Gender: F 18/M 24 Smokers: excluded Teeth treated: 17 of the 56 sites were from upper and lower single‐rooted teeth, and the remaining 39 sites were from upper and lower multirooted teeth Number randomised (participants/teeth): 42/69 Number evaluated (participants/teeth): 35/56 |
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| Interventions | Comparison: PRF/OFD versus OFD alone Test group: PRF/OFD (n = 18/28) Control group: OFD alone (n = 17/28) Surgical technique: intrabony defects treated with OFD alone in control group and additionally PRF was added in test group Follow‐up duration: 9 months |
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| Outcomes | Clinical: site specific PI, modified sulcus bleeding index, PD, periodontal attachment level, gingival margin level Radiographic: radiographic intrabony defect depth Other: none |
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| Notes | Sample size calculation: reported Radiographs were taken with a bite block for ensuring reproducibility Comparability at baseline: yes, assessed Complications reported: yes Dropouts: reported, reasons given, 7 patients, 13 sites did not return for follow‐up examinations |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The selected sites were divided randomly (by using a coin‐toss method) into control and test groups" Comment: correct method for random sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided for allocation concealment method |
| 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: "One operator (AS) performed all surgeries whereas another operator (ARP) performed all clinical and radiographic measurements without knowledge of the groups" Comment: blinding of outcome assessment properly done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 patients out of 42 failed to complete the study |
| Selective reporting (reporting bias) | Low risk | All outcomes properly reported |