Intraoral clinical evaluation of wound healing and microbial dynamics of an herbal gel coated suture - a randomised control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Wound healing will be assessed using the Early Wound Healing Index (EHS) on the 3rd and 7th postoperative days. Higher scores will indicate better healing outcomes.
研究概览
简要总结
This study aims to evaluate wound healing following intraoral implant or minor dental surgical procedures. The patients will be divided into two groups: Group 1 (control) will receive black braided silk sutures, while Group 2 (study group) will receive Abelmoschus esculentus gel-coated sutures for flap approximation. Informed consent will be obtained from all participants, and both groups will receive the same dosage of antibiotics as indicated. Post-operative management and oral hygiene instructions will be provided to all patients.
Wound healing will be assessed using the Early Wound Healing Index (EHS) on the 3rd and 7th postoperative days, with clinical parameters such as re-epithelialization, hemostasis, and inflammation scored to determine healing progress. On the 7th day, sutures will be removed under sterile conditions, and a 1 cm segment of the suture will be analyzed for microbial contamination, specifically for Staphylococcus aureus and Porphyromonas gingivalis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Patients scheduled for dental implants or dental surgical procedures with the incision site flap wide enough to hold the suture Periodontally sound patients Patients with good oral hygiene Patients willing to participate in the study.
排除标准
- •Patients with any evidence of systemic diseases such as diabetes mellitus, peripheral vascular disease, blood clotting disorders, or collagen vascular disease, history of keloid formation or a tendency to form hypertrophic scars.
- •Any local pathology of soft tissue or bone of acute nature Any person who after blood investigations, are found to be HBsAg positive or HIV positive History of allergy to any medication or material Uncooperative patients; mentally retarded patients Poorly compliant patients, who are likely not to maintain their oral hygiene or cleanliness of the surgical site Pregnant and lactating women.
结局指标
主要结局
Wound healing will be assessed using the Early Wound Healing Index (EHS) on the 3rd and 7th postoperative days. Higher scores will indicate better healing outcomes.
时间窗: 3rd and 7th postoperative days.
次要结局
- Microbial analysis of Staphylococcus aureus and Porphyromonas gingivalis will be conducted on the sutures removed on the 7th postoperative day to evaluate the bacterial load and compare microbial colonization between conventional and Abelmoschus esculentus gel-coated sutures.(7th day)
研究者
Dr Manasa Bhide
A.J Institute of Dental Sciences