METHODS: This 6-month randomized controlled clinical trial was carried out in 42 intrabony periodontal defects (average age 40 years). Intrabony defects ≥ 3 mm along with associated probing depth of ≥ 5 mm following phase 1 periodontal therapy were treated either with open flap debridement with bone graft (β-tricalcium phosphate + hydroxyapatite; control group) or open flap debridement with bone graft plus platelet-rich fibrin membrane (test group). Individual customized acrylic stents with grooves were used to ensure reproducible and repeatable measurements of clinical and radiographic parameters, including probing pocket depth (PPD), relative clinical attachment level (RCAL), gingival marginal level (GML), vertical bone defect fill (VHD), and area of intrabony defects (AOD) on intraoral periapical radiographs. Clinical attachment level (CAL) gain was considered as primary outcome and PPD reduction and radiographic bone fill as secondary outcomes.
RESULTS: The preoperative Plaque Index, RCAL, GML, PPD, VHD, and AOD in the control group were 1.06 ± 0.08, 11.57 ± 2.29 mm, 5.24 ± 1.89 mm, 6.29 ± 1.52 mm, 14.36 ± 2.65 mm, and 7.79 ± 4.39 mm2, respectively. After 6 months these were 1.08 ± 0.14, 9.34 ± 2.54 mm, 5.81 ± 2.20 mm, 3.52 ± 0.93 mm, 12.64 ± 2.34 mm, and 5.34 ± 3.2 mm2, respectively. The preoperative PI, RCAL, GML, PPD, VHD, and AOD in the experimental group were 1.14 ± 0.05, 12.19 ± 2.86 mm, 4.38 ± 1.63 mm, 7.81 ± 2.6 mm, 13.46 ± 3.42 mm, and 10.31 ± 8.71 mm2, respectively. After 6 months these were 1.09 ± 0.12, 8.62 ± 2.62 mm, 4.90 ± 1.79 mm, 3.71 ± 1.68 mm, 10.10 ± 2.07 mm, and 4.38 ± 2.67 mm2, respectively. After 6 months of evaluation both the groups showed a significant reduction in PPD (P < .001) and a significant gain in CAL (P < .001), as well as significant improvement in radiographic VHD fill and AOD changes. Again, the test group showed significant changes (P < .001) over the control group considering the same outcomes.
CONCLUSIONS: With the study limitations in mind, it can be concluded that for the treatment of intrabony defects with the bone graft material (β-tricalcium phosphate + hydroxyapatite; Biograft, IFGL Bio Ceramics) or the same bone graft with platelet-rich fibrin membrane results in statistically significant improvement in clinical (CAL and PPD) and radiographic (VHD and AOD) parameters, the latter having highly significant benefits. However, the bone graft material requires improvement.
方法:这是一项为期6个月的随机对照临床试验,在42例牙周炎IBDs中进行(平均年龄40岁)。
结论:考虑到研究的局限性,