Laura Benyei, Anton Friedmann, Thomas Ostermann, Daniel Diehl
{"title":"使用次氯酸钠/氨基酸凝胶和交联透明质酸对残留牙周袋进行非手术治疗--一项为期 9 个月的试验性随机对照临床试验。","authors":"Laura Benyei, Anton Friedmann, Thomas Ostermann, Daniel Diehl","doi":"10.1007/s00784-024-05906-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10461,"journal":{"name":"Clinical Oral Investigations","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11377593/pdf/","citationCount":"0","resultStr":"{\"title\":\"Non-surgical treatment of residual periodontal pockets using sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid-a 9-month pilot randomized controlled clinical trial.\",\"authors\":\"Laura Benyei, Anton Friedmann, Thomas Ostermann, Daniel Diehl\",\"doi\":\"10.1007/s00784-024-05906-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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. 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引用次数: 0
摘要
试验目的这项试验性随机对照临床试验比较了通过龈下器械治疗结合辅助使用次氯酸钠/氨基酸凝胶和交联透明质酸(xHyA)或单独使用龈下器械治疗,在为期9个月的随访期间对顽固性牙周袋取得的临床疗效:研究方案已在 Clinicaltrials.gov 网站的 NCT06438354 下注册。完成第二步非手术牙周治疗后寻求进一步治疗的患者接受重复龈下器械治疗,同时辅助应用次氯酸钠/氨基酸凝胶和交联透明质酸(A组),或仅接受重复龈下器械治疗(B组)。两组均由一名经过校准的研究人员执行相应的治疗顺序。两组患者均在局部麻醉下使用手动和超声波器械对残留牙周袋进行龈下器械治疗,并进行空气抛光。指导患者继续保持口腔卫生,不受任何限制。3 个月再次评估时,在探诊深度持续为 5 毫米和 BoP + 的部位重复进行相应的治疗。在基线(T1)、术后 3 个月(T2)和术后 9 个月(T3)分别记录了临床附着水平(CAL)、牙槽探查深度(PPD)、牙龈退缩(GR)和探查出血(BoP),并将临床附着水平(CAL)作为主要结果指标:共有 52 名患者(20 名女性和 32 名男性,平均年龄为 58.4 ± 2.4 岁)参加了此次研究,他们有 1448 个部位需要进一步的牙周治疗。两组患者在年龄、性别、吸烟习惯、初始治疗部位数量和 BOP 方面均具有同质性。在为期 9 个月的评估中,试验组和对照组的 PD 减少量和 CAL 增加量有显著差异,有利于辅助治疗。与对照组相比,试验组的 GR 有更大的恢复趋势。虽然试验组和对照组的 BOP 频率都有效降低,但两组之间没有统计学意义上的显著差异:在研究范围内,目前的数据表明,在对持久性牙周袋进行龈下器械治疗时,辅助使用次氯酸钠/氨基酸凝胶和 xHyA 可以充分改善临床效果。在 A 组中观察到的 CAL 持续改善和 GR 评分表明,接受辅助治疗的部位在 9 个月的随访期内可能会对治疗产生再生反应。
Non-surgical treatment of residual periodontal pockets using sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid-a 9-month pilot randomized controlled clinical trial.
Objectives: 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.
Materials and methods: 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.
Results: 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.
Conclusion: 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.
期刊介绍:
The journal Clinical Oral Investigations is a multidisciplinary, international forum for publication of research from all fields of oral medicine. The journal publishes original scientific articles and invited reviews which provide up-to-date results of basic and clinical studies in oral and maxillofacial science and medicine. The aim is to clarify the relevance of new results to modern practice, for an international readership. Coverage includes maxillofacial and oral surgery, prosthetics and restorative dentistry, operative dentistry, endodontics, periodontology, orthodontics, dental materials science, clinical trials, epidemiology, pedodontics, oral implant, preventive dentistiry, oral pathology, oral basic sciences and more.