Comparison of tooth Extraction socket healing in patients with type 2 diabetes under oral hypoglycemic drugs versus non diabetic a prospective comparative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate and quality of extraction socket healing using Landry et al wound healing index on 7th post operative day
研究概览
简要总结
Title Comparison of Tooth Extraction Socket Healing in Patients with Type 2 Diabetes under Oral Hypoglycemic Drugs versus Non-Diabetic Patients A Prospective Comparative Study
Background
Diabetes mellitus, particularly Type 2, impairs wound healing due to microvascular changes such as basement membrane thickening, reduced leukocyte migration, impaired perfusion, and tissue hypoxia. These factors may adversely affect post-surgical recovery. Since the oral cavity has unique features like high vascularity, bone turnover, and microbial presence, extraction socket healing in diabetic patients requires specific evaluation.
Aim:
To compare extraction socket wound healing between Type 2 diabetic patients on oral hypoglycemic drugs and non-diabetic patients.
Hypotheses:
Null Hypothesis: Diabetic patients have delayed wound healing compared to non-diabetic patients.
Alternate Hypothesis: No significant difference exists in healing between diabetic and non-diabetic patients.
Objectives:
Assess the association between diabetic status and extraction socket healing.
Record the number of patients reporting delayed healing within 7 days.
Methodology:
Design: Prospective comparative study.
Setting: Dept. of Oral & Maxillofacial Surgery, Rajas Dental College & Hospital.
Sample: 50 patients divided into 2 groups n is equal to 25 each
Group 1: Type 2 diabetics on oral hypoglycemics.
Group 2: Non-diabetic controls.
Inclusion: Adults (>18 yrs), HbA1c <8%, RBS <350 mg/dl, patients requiring intra-alveolar extractions.
Exclusion: Type 1 diabetes, systemic conditions affecting healing (HIV, chemotherapy, steroids, bisphosphonates, etc.).
Procedure:
Extractions under local anesthesia with 3-0 silk sutures.
Post-op meds: Amoxicillin 500 mg TID + Aceclofenac/Paracetamol.
Follow-up at 7 days to assess healing.
Assessment Tool: Landry Wound Healing Index (1988).
Statistics:
Descriptive statistics.
Intra-group comparison: Wilcoxon test.
Inter-group comparison: Mann-Whitney U test.
Significance: p<0.05.
Expected Outcome:
To determine whether controlled Type 2 diabetics under medication show delayed or comparable wound healing relative to non-diabetics after tooth extraction.
References:
Rosenberg (1990), Lioupis (2005), Aronovich et al. (2010), Landry et al. (1988).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who consent to be part of study.
- •Patient with type 2 diabetes and treatment under oral hypoglycemics.
- •Patients indicated for intra alveolar extraction.
- •Range of RBS level less than 350mg slash dL, HbA1C less than 8 percentage.
排除标准
- •Patients unable to give consent due to physical or mental disability.
- •Dental infections with local and systemic involvement.
- •Type 1 diabetes and insulin dependent.
- •Type 2 diabetes plus HIV slash AIDS; chemotherapy; systemic steroids; irradiation to the head and neck; bisphosphonates; anticoagulant and anti platelet treatment; and major benign or malignant pathology within the jaws.
结局指标
主要结局
Rate and quality of extraction socket healing using Landry et al wound healing index on 7th post operative day
时间窗: Rate and quality of extraction socket healing using Landry et al wound healing index on 7th post operative day | Baseline of the study 7th day
次要结局
- Number of patients with delayed wound healing(7 days)
研究者
Dr S Sindhujadevi
Rajas Dental College and Hospital