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

Hanna 2004.

Methods Trial design: randomised, split‐mouth, double‐blinded trial
Location: The University of Texas Health Science Center at Houston, Texas, USA
Number of centres: 1
Recruitment period: not reported
Source of funding: not stated
Ethical approval: yes, Committee for the Protection of Human Subjects at the University of Texas Health Science Center at Houston, Texas, USA
Number of surgeons: 1
Participants Inclusion criteria: patients between 35 to 75 years of age; exhibited plaque score of 20% or less prior to the surgical phase; teeth with mobility less than
 Miller's Class III or mobile teeth requiring splinting; and teeth responding normally to vitality testing or with stable endodontic therapy
 Exclusion criteria: known systemic diseases and/or drug therapy known to interfere with wound healing; known drug allergies to any of the medications
 used in the study; using systemic antibiotics or having received antibiotic therapy in the last 3 months; abnormal platelet counts disclosed by a complete
 blood count (CBC) test performed within 1 month prior to surgery; and participation in other dental clinical trials
 Age at baseline: 37 to 74 years
 Gender: F 8/M 5
 Smokers: yes, 1 heavy smoker (> 20 cigarettes/day)
 Number randomised (participants/teeth): 13/26
 Number evaluated (participants/teeth): 13/26
Interventions Comparison: BDX + PRP versus BDX alone
Test group: BDX + PRP (n = 13 defects)
Control group: BDX alone (n = 13 defects)
Surgical technique: OFD + intrabony defects treated with BDX alone in control group and additionally PRP was applied in test group
Follow‐up duration: 6 months
Outcomes Clinical: GI, PI, PD, CAL, recession as the position of the gingival margin from the CEJ, and BOP
Radiographic: none reported
Other: none
Notes Sample size calculation: not reported
Comparability at baseline: yes, assessed
Complications reported: yes
Dropouts: reported, no dropouts
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed immediately following defect debridement by the flip of a coin"
Comment: correct method for random sequence generation
Allocation concealment (selection bias) Unclear risk Quote: "Randomization was performed immediately following defect debridement by the flip of a coin"
Comment: not sufficient information provided regarding the method of allocation concealment
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: "13 patients were enrolled in a randomized, split‐mouth, double‐masked clinical trial"
Comment: blinding of outcomes likely to have been done properly
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised patients completed the study
Selective reporting (reporting bias) Low risk All outcomes properly reported