Devina Anggun Alfreda, Halim Felita Clarissa, Meivi Meivi, Masulili Sri Lelyati C, Tadjoedin Ette Soraya Shahnaz, Lessang Robert, Widaryono Adityo, Bachtiar Boy M, Sulijaya Benso, Tadjoedin Fatimah Maria, Haerani Natalina, Harsas Nadhia Anindhita, Bakker Astrid Diana
Periodontology Specialist Program, Department of Periodontology, Faculty of Dentistry, Universitas Indonesia, Jakarta, Indonesia.
Department of Periodontology, Faculty of Dentistry, Universitas Indonesia, Jakarta, Indonesia.
Eur J Dent. 2024 Oct;18(4):1090-1100. doi: 10.1055/s-0044-1782188. Epub 2024 Jul 29.
This double-blind randomized clinical trial assessed the effectiveness of 0.2% hyaluronic acid (HA) gel as an adjunct to scaling and root planning (SRP) in patients with periodontitis and type 2 diabetes mellitus (DM), focusing on changes in clinical periodontal parameters, the expression of inflammatory mediators, and oral pathogens.
The randomized clinical trial involved 36 participants, 18 DM patients, and 18 healthy patients. The participants in each group were randomly assigned to receive placebo or HA gel after SRP. Gingival crevicular fluid and subgingival plaque samples were taken before treatment and at 4-week follow-up. Clinical parameters, interleukin-1β (IL-1β) and IL-10 levels, and proportions of and were evaluated at baseline and follow-up.
Paired -test (parametric data) or Wilcoxon signed-rank test (nonparametric data) was used for intragroup comparison between baseline and follow-up, and comparisons between groups one-way analysis of variance test (parametric data) or Kruskal-Wallis test (nonparametric data).
At 4 weeks, most of the groups showed statistically significant decreases ( ≤ 0.05) in various clinical and biomolecular parameters. However, there were exceptions: the pocket probing depth (PPD) and clinical attachment loss (CAL) parameter did not significantly decrease for the placebo ( > 0.05) non-DM group, and the IL-10 parameter in the DM HA gel group ( = 0.108). Regarding bacterial proportions, the non-DM and DM placebo group exhibited significant test results for after 4 weeks ( ≤ 0.05). In the case of bacteria proportions, they decreased in all groups, but these results were not statistically significant ( 0.05). An intergroup analysis revealed no significant differences ( ≤ 0.05) for bleeding on probing (BOP), PPD, and both proinflammatory and anti-inflammatory cytokines. Only clinical attachment loss (CAL) exhibited a statistically significant intergroup difference 0.042.
The use of 0.2% HA gel into periodontal pockets alongside SRP, for both diabetic and healthy individuals, showed no statistically significant variances in clinical, biomolecular, and microbiological measures.
这项双盲随机临床试验评估了0.2%透明质酸（HA）凝胶作为牙周炎和2型糖尿病（DM）患者龈下刮治和根面平整（SRP）辅助治疗手段的有效性，重点关注临床牙周参数、炎症介质表达及口腔病原体的变化。
该随机临床试验纳入36名参与者，其中18名DM患者和18名健康患者。每组参与者在SRP后随机分配接受安慰剂或HA凝胶。在治疗前及4周随访时采集龈沟液和龈下菌斑样本。在基线和随访时评估临床参数、白细胞介素-1β（IL-1β）和IL-10水平以及牙龈卟啉单胞菌和伴放线聚集杆菌的比例。
组内基线与随访间比较采用配对t检验（参数数据）或Wilcoxon符号秩检验（非参数数据），组间比较采用单向方差分析检验（参数数据）或Kruskal-Wallis检验（非参数数据）。
4周时，大多数组在各种临床和生物分子参数方面显示出有统计学意义的下降（P≤0.05）。然而，也有例外情况：安慰剂组（P>0.05）非DM组的牙周袋探诊深度（PPD）和临床附着丧失（CAL）参数未显著下降，DM HA凝胶组的IL-10参数（P = 0.108）。关于细菌比例，非DM组和DM安慰剂组在4周后牙龈卟啉单胞菌检测结果有显著差异（P≤0.05）。对于伴放线聚集杆菌比例，所有组均下降，但这些结果无统计学意义（P>0.05）。组间分析显示，探诊出血（BOP）、PPD以及促炎和抗炎细胞因子方面无显著差异（P≤0.05）。仅临床附着丧失（CAL）显示出有统计学意义的组间差异（P = 0.042）。
对于糖尿病患者和健康个体，在SRP的同时将0.2%HA凝胶注入牙周袋，在临床、生物分子和微生物学指标方面未显示出有统计学意义的差异。
