0.8%透明质酸作为辅助手段联合开放式清创术治疗牙周内骨缺损的临床和影像学评价：随机对照临床试验。
Clinical and radiographic evaluation of 0.8% hyaluronic acid as an adjunct to open flap debridement in the treatment of periodontal intrabony defects: randomized controlled clinical trial.
机构信息
Department of Periodontology and Oral Implantology, Karmaveer Bhausaheb Hiray Dental College and Hospital, Nashik, Maharashtra, India.
Department of Public Health Dentistry, Government Dental College and Hospital, Mumbai, India.
出版信息
Clin Oral Investig. 2021 Sep;25(9):5257-5271. doi: 10.1007/s00784-021-03834-7. Epub 2021 Feb 17.
OBJECTIVES
Present study aimed to evaluate and compare the clinical and radiographic efficacy of 0.8% hyaluronic acid (HA) gel as an adjunct to open flap debridement (OFD) versus open flap debridement (OFD) alone in the treatment of periodontal intrabony defects.
MATERIALS AND METHODS
This randomized, controlled, split-mouth, clinical trial included 20 chronic periodontitis (stage II or III (grades A to B)) patients, having at least two contralateral intrabony defects. Forty bilateral intrabony defects (20 in each group) were randomly divided into test (0.8% HA gel + OFD) and control (OFD + placebo) groups. Clinical parameters evaluated at baseline, 6-months, and 12-months were plaque index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR). Using cone beam computed tomography (CBCT), radiographic parameters were evaluated at baseline and 12 months. This included bone defect fill (DF), alveolar crest changes (ACC), and defect resolution (DR). CAL served as the primary outcome variable.
RESULTS
After 12 months, the test group showed significantly greater CAL gain (5.1 ± 1.2 versus 4.05 ± 1.19 mm) and bone defect fill (DF) (5.67 ± 2.01 versus 4.49 ± 1.78 mm) compared to the control group. Mean PD reduction in the test group (5.3 ± 1.2 versus 4.35 ± 0.81 mm) was statistically significant compared to the control group at 12-month period. The control group showed statistically significant increase in GR (1.2 ± 0.76 versus 0.7 ± 0.73 mm) compared to the test group after 12 months.
CONCLUSION
Application of hyaluronic acid gel in conjunction with open flap debridement resulted in enhanced clinical and radiographic outcomes compared to open flap debridement alone.
CLINICAL RELEVANCE
Adjunctive application of HA gel in open flap debridement may improve clinical and radiographic outcomes.
CLINICAL TRIAL REGISTERED NUMBER
CTRI/2018/03/012334.
目的
本研究旨在评估和比较 0.8%透明质酸（HA）凝胶作为辅助开放式清创术（OFD）与单独开放式清创术（OFD）治疗牙周骨内缺损的临床和放射学疗效。
材料和方法
这项随机、对照、分侧、临床试验纳入了 20 名慢性牙周炎（Ⅱ或Ⅲ期（A 至 B 级））患者，他们至少有两个对侧骨内缺损。40 个双侧骨内缺损（每组 20 个）被随机分为试验组（0.8%HA 凝胶+OFD）和对照组（OFD+安慰剂）。在基线、6 个月和 12 个月时评估临床参数，包括菌斑指数（PI）、牙龈指数（GI）、探诊深度（PD）、临床附着水平（CAL）和牙龈退缩（GR）。使用锥形束 CT（CBCT）在基线和 12 个月时评估放射学参数，包括骨缺损填充（DF）、牙槽嵴变化（ACC）和缺损愈合（DR）。CAL 为主要观察指标。
结果
在 12 个月时，与对照组相比，试验组的 CAL 增加（5.1±1.2 比 4.05±1.19mm）和骨缺损填充（DF）（5.67±2.01 比 4.49±1.78mm）更显著。与对照组相比，试验组在 12 个月时 PD 降低（5.3±1.2 比 4.35±0.81mm）也具有统计学意义。与试验组相比，对照组在 12 个月时 GR 增加（1.2±0.76 比 0.7±0.73mm）具有统计学意义。
结论
与单独开放式清创术相比，透明质酸凝胶联合开放式清创术可提高临床和放射学效果。
临床相关性
开放式清创术联合 HA 凝胶的应用可能改善临床和放射学效果。
临床试验注册号
CTRI/2018/03/012334。
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