Comparative evaluation of wound healing in periodontal flaps approximated with N-hexyl cyanoacrylate and Isoamyl 2-cyanoacrylate tissue adhesives – A clinico-histological study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Wound healing index (Landry, Turnbull, and Howley index)
研究概览
简要总结
Background: Periodontal surgical procedures are carried out for management of disease induced changes in periodontium and regeneration of lost periodontal tissues. Conventional methods used for flap approximation such as sutures, may cause trauma during needle penetration while passing through the tissues and provide a “wick down†through which bacteria can gain access to the underlying tissues. N-Hexyl Cyanoacrylate is a hybrid tissue sealant which is an innovative technology used in mesh fixation and haemostasis in digestive, visceral & uro-gynecological surgeries and showed fast-acting tissue adhesive properties hence widely used in medical surgical procedures now a days. Also, Isoamyl-2-cyanoacrylate has been the most popular and common tissue adhesive that offers advantages such as immediate haemostasis, bacteriostatic proprieties, and rapid adhesion to soft and hard tissues.
Objectives: To evaluate and compare the clinical and histological healing of surgical sites approximated with N-hexyl cyanoacrylate, Isoamyl-2-cyanoacrylate as tissue adhesives and silk suture.
Materials & methods: Total 30 patients will be selected and divided into three study groups randomly, 10 of each group. Signed informed consent will be obtained from the patients. N-hexyl-cyanoacrylate, Isoamyl-2-cyanoacrylate and Silk sutures will be used to approximate flap following periodontal flap surgery for the group 1, 2 & 3 respectively. The clinical parameters will be recorded after an interval of 7 days, 15 days and 1 month which will be evaluated using Wound healing index (Landry, Turnbull, and Howley index), Pain score (Visual Analogue Scale) and Plaque index (Quigley Hein Index (Modified), 1970). Standardized gingival punch biopsies will be taken and histological examination will be performed on 7th day.
Statistical analysis: Data will be analysed statistically using appropriate software.
Expected outcomes: There is a great possibility of significant difference in wound healing of periodontal surgical sites approximated with N-hexyl-Cyanoacrylate than Isoamyl-2-Cyanoacrylate and silk sutures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic periodontitis subjects indicated for periodontal flap surgery.
排除标准
- •Subjects with any pre-existing pathology.
- •Subjects with systemic diseases which delays the healing, cardiovascular diseases, poorly controlled diabetes, HIV, cancer, haemorrhagic disorders.
- •Subjects having history of drug allergy, food allergy or allergy to polymers in cyanoacrylate, glues, tissue adhesives.
- •Pregnant or lactating women.
- •Subjects using tobacco (In any form).
- •Chronic use of antimicrobial, ant-inflammatory drugs and other medications 6 months prior to the study.
结局指标
主要结局
1. Wound healing index (Landry, Turnbull, and Howley index)
时间窗: 7th day, 15th day, 1 month follow-up
2. Pain score (Visual Analogue Scale)
时间窗: 7th day, 15th day, 1 month follow-up
3. Plaque index
时间窗: 7th day, 15th day, 1 month follow-up
次要结局
- Histological examination(7th day)
研究者
Yogita Uttam Landge
YCMM and RDFs Dental Collage and Hospital Ahmednagar