Department of Periodontology, Faculty of Health, Witten/Herdecke University, 58445, Witten, Germany.
Implantat Competence Centrum München, 80333, Munich, Germany.
Clin Oral Investig. 2024 Sep 5;28(9):513. doi: 10.1007/s00784-024-05906-w.
This pilot randomized controlled clinical trial compares the clinical outcome obtained in persistent periodontal pockets during 9-month follow-up of supportive periodontal step 4 treatment performed by either combining subgingival instrumentation with adjunctively used sodium hypochlorite/amino acid gel and crosslinked hyaluronic acid (xHyA) or subgingival instrumentation alone.
Study protocol is registered under NCT06438354 at Clinicaltrials.gov. Patients seeking further therapy after completed step 2 non-surgical periodontal treatment underwent either repeated subgingival instrumentation with adjunctive application of sodium hypochlorite/amino acid gel and crosslinked hyaluronic acid (group A) or repeated subgingival instrumentation alone (group B). One calibrated investigator performed the treatment sequence in both groups accordingly. Subgingival instrumentation of the residual pockets was carried out under local anaesthesia using hand- and ultrasonic instruments, as well as air polishing in both groups. Patients were instructed to continue oral hygiene without any restriction. At 3-month re-evaluation treatment was repeated accordingly at sites with persistent 5 mm probing depth and BoP + . Clinical attachment level (CAL), pocket probing depth (PPD), gingival recession (GR), and bleeding on probing (BoP) were recorded at baseline (T1), 3- (T2) and 9-month (T3) post-op, with CAL as a primary outcome measure.
In total 52 patients (20 females and 32 males, mean age 58.4 ± 2.4 years) presenting with 1448 sites which required further periodontal treatment were enrolled. Both groups exhibited homogeneity in terms of age, gender, smoking habit, initial number of sites, and BOP. At 9-month evaluation, PD reduction and CAL gain showed significant differences between the test and control group, favouring the adjunctive treatment. GR tended to exhibit more recovery in the test group compared to the control group. Although BOP frequency effectively reduced in both groups, there was no statistically significant difference between the two groups.
Within the limits of the study, the present data indicates that, during subgingival instrumentation of persistent pockets, the adjunctive usage of sodium hypochlorite/amino acid gel and xHyA sufficiently improves the clinical outcomes. The continuous improvement of CAL in association with the GR scores observed in group A, indicates that sites subjected to adjunctive treatment may indicate a tendency for a regenerative response to treatment within the 9-month follow-up period.
本试点随机对照临床试验比较了在第 4 阶段牙周支持治疗中，对持续牙周袋进行治疗 9 个月的临床结果，该治疗方法是在龈下器械治疗的基础上，联合使用次氯酸钠/氨基酸凝胶和交联透明质酸（xHyA）或单独使用龈下器械。
研究方案在 Clinicaltrials.gov 上注册为 NCT06438354。完成第 2 阶段非手术牙周治疗后寻求进一步治疗的患者，要么接受重复龈下器械治疗，联合应用次氯酸钠/氨基酸凝胶和交联透明质酸（A 组），要么仅接受重复龈下器械治疗（B 组）。一名经过校准的研究人员在两组中都按照治疗顺序进行操作。两组均在局部麻醉下使用手工和超声器械以及空气抛光进行龈下器械治疗。两组患者均被要求继续进行口腔卫生，不受任何限制。在 3 个月的再评估时，对持续存在 5mm 探诊深度和 BoP+的部位，根据需要重复治疗。在基线（T1）、3 个月（T2）和 9 个月（T3）时记录临床附着水平（CAL）、探诊深度（PPD）、牙龈退缩（GR）和探诊出血（BoP），CAL 作为主要观察指标。
共有 52 名患者（20 名女性和 32 名男性，平均年龄 58.4±2.4 岁），共 1448 个部位需要进一步的牙周治疗，被纳入研究。两组在年龄、性别、吸烟习惯、初始部位数量和 BoP 方面均具有同质性。在 9 个月的评估中，试验组和对照组的 PD 减少和 CAL 增加均有显著差异，有利于辅助治疗。GR 倾向于在试验组中比对照组中恢复更多。虽然两组的 BoP 频率都有效降低，但两组之间没有统计学上的显著差异。
在研究范围内，目前的数据表明，在持续牙周袋的龈下器械治疗中，次氯酸钠/氨基酸凝胶和 xHyA 的联合使用可显著改善临床疗效。A 组中 CAL 的持续改善与 GR 评分的提高一致，表明接受辅助治疗的部位可能在 9 个月的随访期内显示出对治疗的再生反应趋势。
