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臭氧凝胶应用与否对控制 2 型糖尿病伴牙周炎患者的非手术治疗的临床和影像学评估:一项随机对照临床试验。

Clinical and radiographic evaluation of non-surgical therapy with and without ozone gel application in controlled type 2 diabetic patients with periodontitis: a randomized controlled clinical trial.

机构信息

Oral Medicine & Periodontology Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Oral and Maxillofacial Radiology Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

出版信息

BMC Oral Health. 2024 Nov 25;24(1):1435. doi: 10.1186/s12903-024-05212-7.

Abstract

BACKGROUND

The current study aimed to assess the clinical and radiographic outcomes of the effect of subgingival application of ozonated gel as an adjunct to scaling and root planing (SRP) in diabetic patients with stage III periodontitis.

METHODS

Twenty-four patients with type II diabetes mellitus (DM) were randomized into two groups, with 12 patients in each group. Group I served as the intervention group, receiving both SRP and ozone gel application (SRP + Ozone), while Group II served as the control group, undergoing SRP alone. Clinical attachment level was evaluated as primary outcome, with secondary outcomes including probing pocket depth, full mouth plaque score, full mouth bleeding score, dentinal hypersensitivity, radiographic linear defect depth, radiographic defect angle, and periodontal ligament widening space assessed at 3 and 6 months.

RESULTS

The results revealed statistically significant intragroup differences between the two groups (p < 0.05). In contrast, intergroup differences revealed no statistically significant difference across the various time intervals (p > 0.05). The reduction in PD in the SRP + Ozone group at three months was statistically significant (p = 0.04). The SRP + Ozone group showed a significant radiographic improvement compared to the SRP group. The Visual Analogue Scale (VAS) also demonstrated statistically significant differences between the two groups. Glycated hemoglobin (HbA1c) significantly decreased after 6 months, with no significant signifcant differences between groups (p > 0.05).

CONCLUSIONS

Ozone gel is suggested to be a promising potential natural adjunctive therapy for diabetic patients to enhance periodontal health, with no reported adverse effects.

TRIAL REGISTRATION

ID: NCT05538078, Date of Registration: 09/09/2022. ( https://register.

CLINICALTRIALS

gov/prs/app/action/DownloadReceipt?uid=U0006D54&ts=3&sid=S000CGX4&cx=g1wreh ).

摘要

背景

本研究旨在评估向有牙周炎 III 期的糖尿病患者的龈下应用臭氧凝胶作为牙周刮治和根面平整(SRP)辅助治疗的临床和放射学效果。

方法

将 24 例 2 型糖尿病(DM)患者随机分为两组,每组 12 例。第 I 组为干预组,接受 SRP 和臭氧凝胶应用(SRP+臭氧),第 II 组为对照组,仅接受 SRP。临床附着水平为主要结局,次要结局包括探查袋深度、全口菌斑评分、全口出血评分、牙本质敏感、放射线性缺损深度、放射缺损角度和牙周韧带增宽空间,分别在 3 个月和 6 个月评估。

结果

结果显示两组组内差异具有统计学意义(p<0.05)。相比之下,各时间点组间差异无统计学意义(p>0.05)。SRP+臭氧组在三个月时 PD 的减少具有统计学意义(p=0.04)。SRP+臭氧组与 SRP 组相比,放射学改善显著。视觉模拟量表(VAS)也显示两组之间有统计学差异。6 个月后糖化血红蛋白(HbA1c)显著降低,两组之间无显著差异(p>0.05)。

结论

臭氧凝胶被认为是一种有前途的、潜在的天然辅助治疗方法,可增强糖尿病患者的牙周健康,且无不良反应报告。

试验注册

ID:NCT05538078,注册日期:2022 年 9 月 9 日(https://register.clinicaltrials.gov/prs/app/action/DownloadReceipt?uid=U0006D54&ts=3&sid=S000CGX4&cx=g1wreh)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/55f7/11590345/c6a57b2b770c/12903_2024_5212_Fig1_HTML.jpg

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