Elgendy 2015.
Methods | Trial design: randomised, split‐mouth trial Location: Department of Periodontology, Faculty of Dentistry, October 6 University and Tanta University, Egypt Number of centres: 2 Recruitment period: February to December 2013 Source of funding: not stated Ethical approval: Research Ethical Committee of Tanta University, Egypt Number of surgeons: not stated |
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Participants | Inclusion criteria: presence of 2 almost identical interproximal intrabony defects, 1 on either side of the arch based on radiographic observations with clinical probing depth ≥ 6 mm in teeth Exclusion criteria: any systemic disease that affect the periodontium and contraindicate for periodontal surgery; patients having insufficient platelet count for PRF preparation; patients with coagulation defect or anticoagulation treatment; pregnant or lactating mothers; postmenopausal women; people who take anti‐inflammatory drugs, antibiotics or vitamins within the previous 3 months; people who use mouthwashes regularly; heavy smoking (> 10 cigarettes/day); history of alcohol abuse; unacceptable oral hygiene after the re‑evaluation of phase I therapy Age at baseline: group I 44.25 ± 8.45 years, group II 39.70 ± 6.36 years Gender: not stated Smokers: heavy smokers (> 10 cigarettes/day) were excluded Teeth treated: not reported Number randomised (participants/teeth): 20/40 Number evaluated (participants/teeth): 20/40 | |
Interventions | Comparison: PRF + NcHA bone graft versus NcHA bone graft alone Test group: PRF + NcHA bone graft (n =20) Control group: NcHA bone graft alone (n = 20) Surgical technique: OFD + intrabony defects were treated with NcHA bone graft alone in control group and PRF was additionally applied in test group Follow‐up duration: 6 months |
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Outcomes | Clinical: PI, GI, PPD, CAL Radiographic: bone density Other: none |
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Notes | Sample size calculation: reported Comparability at baseline: yes, assessed Complications reported: no Dropouts: not reported, reasons not given |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Selected sites were randomly divided into 2 groups" Comment: insufficient information regarding the random sequence generation method |
Allocation concealment (selection bias) | Unclear risk | Quote: "Selected sites were randomly divided into 2 groups" Comment: insufficient information regarding 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 | Unclear risk | No information is provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is unclear wether or not all patients completed the study |
Selective reporting (reporting bias) | Low risk | All outcomes properly reported |