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. 2018 Nov 26;2018(11):CD011423. doi: 10.1002/14651858.CD011423.pub2

Pradeep 2015.

Methods Trial design: randomised, longitudinal, triple‐masked, parallel trial
Location: Department of Periodontics, Government Dental College and Research Institute, Bangalore, India
Number of centres: 1
Recruitment period: November 2013 to July 2014
Source of funding: not stated
Ethical approval: Institutional Ethical Committee and Review Board of the Government Dental College and Research Institute, Bangalore, India
Number of surgeons: 1
Participants Inclusion criteria: presence of intrabony defect ≥ 3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph (IOPA)) along with an interproximal PD ≥ 5 mm after phase I therapy (scaling and root planing) in asymptomatic maxillary/mandibular molar teeth
 Exclusion criteria: aggressive periodontitis patients; patients with systemic conditions known to affect the periodontal status; medications known to affect the outcomes of periodontal therapy; haematological disorders and insufficient platelet count (< 200,000/mm3); pregnancy/lactation; smoking and tobacco use in any form; and immunocompromised individuals. Those having unacceptable oral hygiene (PI > 1.5) after re‐evaluation of phase I therapy were also excluded. In addition, teeth with furcation defects, non‐vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded
 Age at baseline: mean = 41 years
 Gender: F 68/M 68 (for all 4 groups)
 Smokers: excluded
 Teeth treated: maxillary and mandibular molar
 Number randomised (participants/teeth): 64/64 (126/126 for all 4 groups; 136 eligible but 10 excluded at time of surgery)
 Number evaluated (participants/teeth): 60/60 (120/120 for all 4 groups)
Interventions Comparison: OFD alone versus OFD + PRF
Group 1: OFD alone (n = 30)
Group 2: OFD + PRF (n = 30)
Surgical technique: in group 1, only OFD was done, without addition of any regenerative material into the bone defect; in group 2, PRF of the required size was filled into the intrabony defect after OFD
Follow‐up duration: 9 months
Outcomes Clinical: site specific PI, modified sulcus bleeding index, relative attachment level, gingival marginal level
Radiographic: radiographic intrabony defect depth
Other: none
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, 4 dropouts (6 for all 4 groups)
3rd and 4th group data (OFD + 1% metformin and OFD + PRF + 1% metformin) not included in this review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "These patients were divided randomly (computer generated tables) into 4 groups"
Comment: random sequence generation properly done
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 given the surgical nature of the treatment. For the same reason, blinding of the patient, even though it was done, does not influence the outcome of the treatment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quotes: "This was a randomized, single‐centre, longitudinal, triple‐masked (investigators, individuals and statistician), parallel arm design study" and "One operator (KN) performed all the surgeries, whereas another operator (ARP) performed all the 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 4 dropouts (6 for all 4 groups)
Selective reporting (reporting bias) Low risk All outcomes properly reported