EVALUATION OF THE EFFECTIVENESS OF CHITOSAN-BASED DRESSING ON WOUND HEALING BY SECONDARY INTENTION: AN IN VIVO STUDY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1. Assessment of Pain on 1st, 3rd and 7th day respectively
研究概览
简要总结
This in vivo randomized controlled trial evaluates the effectiveness of chitosan-based dressing (AXIOSTAT) on gingival wound healing by secondary intention following gingivectomy. A total of 26 systemically healthy patients requiring excisional gingival procedures will be selected and randomly allocated into two groups. Group A (control) will receive Coe-Pak periodontal dressing alone, while Group B (test) will receive chitosan dressing with Coe-Pak. Pain will be assessed using the Visual Analogue Scale (VAS) on days 1, 3, and 7. Healing will be evaluated using the Landry Healing Index on days 7, 15, and 30. The study will follow a single-blinded design to reduce bias.
Chitosan is a natural biopolymer derived from chitin with excellent biocompatibility, antimicrobial properties, and hemostatic potential. Its sponge form promotes clot stabilization, enhances tissue regeneration, and offers improved healing in open wounds. This study aims to compare its efficacy with conventional periodontal dressings in terms of pain reduction and accelerated healing. Ethical clearance and CTRI registration will be obtained. The findings of this study may help establish chitosan as a superior biomaterial for post-surgical wound management in periodontology, improving patient comfort and clinical outcomes during healing by secondary intention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 22.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects requiring excisional gingival procedures undergoing healing by secondary intention.
- •Subjects with gingival enlargement Grade greater or equal to 2 involving at least 3 teeth on each side of the midline in an arch.
- •Subjects who gave written informed consent.
排除标准
- •Subjects taking any medication which can influence the gingival response during healing
- •Subjects with any systemic disease affecting the periodontium
- •Pregnant women, lactating mothers, postmenopausal women
- •Subjects with any blood dyscrasia or bleeding disorder
- •Smokers and tobacco chewers
- •Subjects who were unable to perform routine oral hygiene procedures or not complying with oral hygiene instructions.
结局指标
主要结局
1. Assessment of Pain on 1st, 3rd and 7th day respectively
时间窗: 1. Assessment of Pain on 1st, 3rd and 7th day respectively | 2. Assessment of Healing on 7th, 15th and 30th day respectively
2. Assessment of Healing on 7th, 15th and 30th day respectively
时间窗: 1. Assessment of Pain on 1st, 3rd and 7th day respectively | 2. Assessment of Healing on 7th, 15th and 30th day respectively
次要结局
- To compare the results in both the groups that is control group coepak alone & test group chitosan based dressing with coepak after 2 years(To compare the results in both the groups that is control group coepak alone & test group chitosan based dressing with coepak after 2 years)
研究者
Dr Shivi Mittal
Department of Periodontology
