跳至主要内容
临床试验/CTRI/2024/02/062384
CTRI/2024/02/062384已完成4 期

Comparison of two different sutures on postoperative complications following periapical surgeries: A prospective, randomised controlled trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
To compare the efficacy of 4-0 prolene (3/8 reverse cutting) versus 4-0 PTFE suture (3/8 reverse cutting) in periapical surgeries in terms of postoperative complications.

研究概览

简要总结

Wound closure is a key element for successfulhealing of surgical sites and aids in reducing postoperative complications likepain, swelling, infection, etc. Literature has advocated use of sutures,surgical clamps, and adhesive agents for securing and stabilizing detachedtissues for the subsequent satisfactory healing. Sutures are the most frequently used medical devicefor wound closure. They support tissue during the early phase of healing untilit regains enough tensile strength. Regardless of the suture material origin,its essential role is to support the tissue until continuity of surface andenough tensile strength is regained during the process of wound healing. Good sutures require specific physicalcharacteristics and properties, such as good resistance to traction,dimensional stability, lack of memory, good knot security, and sufficientflexibility to avoid damage to the oral mucosa. At the same time, theymust avoid or limit bacterial adhesion and proliferation to those parts exposedto oral fluids, thereby avoiding contamination inside the wound. A good suturematerial must show a brief exudative phase and must not interfere with cellularproliferation or connective tissue organization. There are many suturingmaterials now available in the market. These materials are classified asbraided multifilament and monofilament or bio absorbable and nonabsorbable. However, the selection of suture material forperiapical surgery is often based on surgeons’ choices rather than scientificdata and has not been extensively investigated. Hence, we propose a randomizedcontrolled trial to compare efficacy of 4-0 prolene (3/8 reverse cutting)versus 4-0  PTFE suture (3/8 reversecutting) in periapical surgeriesin terms of postoperative complications, along with patient as well assurgeon’s satisfaction.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • All adult patients (18-65 years) presenting with Periapical lesion that requires Apicectomy.

排除标准

  • Patients with uncontrolled systemic diseases, 2) Patients who are not willing to give consent for participation in the study, 3) Extensive lesion that requires intervention under general anesthesia, 4) Lesions of non endodontic origin.

结局指标

主要结局

To compare the efficacy of 4-0 prolene (3/8 reverse cutting) versus 4-0 PTFE suture (3/8 reverse cutting) in periapical surgeries in terms of postoperative complications.

时间窗: Five days Post-operatively

次要结局

  • To compare the 4-0 prolene (3/8 reverse cutting) versus 4-0 PTFE suture (3/8 reverse cutting) in periapical surgeries in terms of patients as well as surgeon’s satisfaction.(Five Days Post-operatively)

研究者

申办方类型
Government medical college

研究点 (1)

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