Shukla 2016.
| Methods | Trial design: randomised, split‐mouth trial Location: outpatient service on a teaching dental institute in North India (no further details given) Number of centres: 1 Recruitment period: not specified Source of funding: not stated Ethical approval: Institutional Ethical Committee and Review Board of the Government Dental College and Research Institute, India Number of surgeons: 1 |
|
| Participants | Inclusion criteria: presence of intrabony defects > 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph (IOPA)) and an interproximal PD > 5 mm Exclusion criteria: known systemic illness; taking any medications known to affect the outcomes of periodontal therapy; pregnancy/lactation; use of any form of tobacco; allergy to calcium phosphosilicate putty Age at baseline: mean = 40 + 10.5 years Gender: F 7/M 13 Smokers: excluded Teeth treated: not stated Number randomised (participants/teeth): 20/40 Number evaluated (participants/teeth): 20/40 | |
| Interventions | Comparison: OFD + calcium phosphosilicate (CPS) + PRF versus OFD + CPS alone Test group: OFD + CPS + PRF (n = 20) Control group: OFD + CPS alone (n = 20) Surgical technique: full thickness mucoperiosteal flap with PRF and CPS in test site and full thickness mucoperiosteal flap with CPS alone in control site Follow‐up duration: 9 months |
|
| Outcomes | Clinical: PI, PD, CAL, GI Radiographic: radiographic bone filling Other: none |
|
| Notes | Sample size calculation: yes Comparability at baseline: yes, assessed Complications reported: no complications Dropouts: no dropouts |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomization was performed using a computer‐generated randomization list" Comment: correct method for random sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information provided on the 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: "All the evaluations were performed by an independent trained observer not involved in the study" Comment: blinding of outcome assessment properly done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed the study |
| Selective reporting (reporting bias) | Low risk | All results properly reported |