跳至主要内容
临床试验/NCT06894667
NCT06894667进行中(未招募)4 期

The Effect of an Antioxidant Gel Compared to Chlorhexidine Gel During the Soft Tissue Healing Process Follow Scaling and Root Planing: A Randomized Controlled Clinical Trial

Kuwait University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Plaque Index

研究概览

简要总结

This study aims to evaluate the comparative impact of chlorhexidine and antioxidant gel on postoperative biomarkers following SRP. By examining biomarkers related to inflammation, oxidative stress, and tissue healing, this research seeks to determine which treatment modality more effectively supports recovery and reduces postoperative complications.

Understanding the differential effects of these interventions on postoperative biomarkers will contribute valuable insights into optimizing SRP outcomes. Correlations between biomarker levels and clinical outcomes, such as periodontal pocket depth and clinical attachment level changes will provide valuable information on the clinical relevance of the findings. This comparison will also guide clinicians in selecting the most appropriate postoperative care to enhance patient recovery and long-term periodontal health.

详细描述

Background

Periodontitis is characterised by inflammation that results in the loss of periodontal attachment. Scaling and root planing (SRP) is a fundamental non-surgical treatment for periodontitis, which aims to remove the primary causative agents - dental plaque and calculus, from the tooth surfaces. Postoperative care is critical to ensure optimal healing and to manage potential inflammation and microbial load. Traditionally, chlorhexidine, an antimicrobial agent, has been utilized as an adjunctive treatment to prevent infection and manage inflammation following SRP. Chlorhexidine's broad-spectrum antimicrobial properties have been well-documented, and its application has been associated with reduced clinical symptoms and enhanced periodontal healing.

However, recent research has suggested potential benefits of antioxidant gels in promoting tissue repair and reducing oxidative stress, which could be beneficial in the postoperative period. Antioxidant gels, containing compounds such as vitamin C, vitamin E, or polyphenols, are proposed to mitigate oxidative damage and inflammation, potentially offering a different mechanism of action compared to traditional antimicrobial approaches.

Given these advances, there is a need to evaluate and compare the efficacy of chlorhexidine and antioxidant gels in managing postoperative outcomes following SRP. Specifically, assessing their impact on postoperative biomarkers, such as inflammatory cytokines, oxidative stress markers, and periodontal tissue regeneration indicators, could provide valuable insights into their relative effectiveness. In an animal model, found that animals treated with antioxidant gels healed faster and also led to an upregulation of TNFalpha and the antioxidant enzyme superoxide dismutase. However, to the best of our knowledge there are no human clinical studies that have established this relationship. Therefore, this study aims to compare the efficacy adjunctive treatment with chlorhexidine and antioxidant gels along with SRP in the management of patients with periodontitis.

Objectives The objectives of this study are to evaluate and compare the effects of chlorhexidine and antioxidant gel on inflammatory biomarkers (e.g.: Tumor Necrosis Factor-alpha (TNF-alpha); and antioxidant related markers (e.g.: Myeloperoxidase (MPO), among patients undergoing scaling and root planing (SRP). Additionally, the study aims to determine the clinical efficacy of these postoperative treatments in modulating the tissue response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The participants would be blinded to the intervention and the outcome assessors would also not know the group to which the participant belonged.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Stage 3 or 4 periodontitis would be invited to participate in this study.
  • The following parameters will be used for the diagnosis of periodontitis: (a) presence of bleeding on gentle probing; (b)probing depth (PD) >6mm; and (c) marginal bone loss (MBL) of at least 3.

排除标准

  • Patients will be excluded from the study if they present with gingivitis alone, are currently using oral contraceptives, have systemic conditions such as diabetes or cancer, or are smokers (including those who quit within the past 6 months).
  • Recent antibiotic use within the last 3 months, NSAID or bisphosphonate use within the last 90 days, and any use of chlorhexidine in the past 6 months.

研究组 & 干预措施

Control Arm

Active Comparator

A local gel containing 0.5% chlorhexidene (Curaprox Perioplus Focus Gel,PERIOPLUS+ FORTE, Curaprox, Curaden) would be administered

干预措施: Antimicrobial gel (Drug)

Test Arm

Experimental

Commercially available antioxidant gel with Tea Tree oil (Tebodont®, Dr. Wild & Co. AG, Basel) would be administered

干预措施: Antioxidant gel (Drug)

结局指标

主要结局

Plaque Index

时间窗: at 1 month post-intervention

to assess plaque accumulation

Gingival index

时间窗: at 1 month post-intervention

for evaluating gingival inflammation

Probing pocket depth (PPD)

时间窗: at 1 month post-intervention

for measuring disease severity. PPD is measured in millimetres

Clinical attachment level

时间窗: at 1 month post-intervention

Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

Bleeding on probing (BoP)

时间窗: at 1 month post-intervention

to assess disease activity

次要结局

  • TNF-α salivary levels(1 month post intervention)
  • MPO salivary levels(1 month post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jagan K Baskaradoss

Associate Professor

Kuwait University

研究点 (1)

Loading locations...

相似试验