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临床试验/CTRI/2024/07/071666
CTRI/2024/07/071666已完成不适用

Comparative evaluation of antimicrobial efficacy of chlorhexidine coated silk suture with uncoated silk suture in subjects with stage II and stage III grade B periodontitis in periodontal flap surgery - A randomized clinical study.

Pandurang Gulabrao Gavhale1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
To evaluate the antimicrobial efficacy of chlorhexidine coated silk suture with respect to Colony forming units.

研究概览

简要总结

The primary goal of periodontal therapy is to arrest the progression of periodontal disease, and regeneration of lost periodontal tissues and maintain the natural dentition in health and comfortable function.      This goal can be accomplished by non-surgical therapy in patients with mild to moderate periodontitis, whereas in advanced cases, open flap debridement in greater success.

Periodontal flaps provide access for root instrumentation, osseous reduction and periodontal regeneration. Optimal flap stabilization promotes the early formation and organization of a blood clot and consequently ensures that the delicate fibrin clot adheres to the hard, non-shedding wound-bed surface. Hence, stabilization and adaptation of the soft tissues covering the wound area with appropriate suturing appears to be a key prerequisite for achieving optimal surgical outcomes.The main problem, however, in the oral cavity is the prolonged immersion of suture in the saliva-containing microorganisms. Once suture material becomes contaminated, biologic agents, chemical agents, or other mechanisms of wound decontamination become ineffective owing to biofilm formation and the subsequent protection it affords to biofilm populations. Sutures can be a source of surgical wound contamination owing to bacterial adherence to them and the suture acting as a means of transmitting bacteria to oral tissues.Silk Sutures are multifilament sutures and requiring more knots and have more tendency than monofilament to absorb the oral liquids fluids and consequently microorganisms into the connective tissue. This results in continuous wicking of microorganisms along the suture at the surgical site which results in a prolonged inflammatory response and surgical site infections.

Development of an antibacterial suture has been under consideration for many years. Sutures impregnated or coated with antibacterial agents have been developed in an attempt to reduce bacterial adherence and colonization. Local drug delivery in the form of coated sutures can be an effective method to inhibit biofilm formation and decrease the bacterial load at the surgical site, thereby reducing the need to give any systemic antibiotics and eliminating the need of antimicrobial mouthwash post-surgery. Moreover, the reduced biofilm formation near the surgical site can also improve the clinical success of any surgery.

Chlorhexidine considered as the “gold standard” in oral antiseptics can be used as it is effective against a broad spectrum of pathogens. At low concentration it acts as a bacteriostatic and at higher concentration it acts as a bactericidal agent. A silk suture coated with the chlorhexidine gel can thus be used. Hence this study is designed to assess chlorhexidine coated silk sutures in periodontal flap surgery.

The aim of the present study is to evaluate and compare the wound healing and antimicrobial efficacy of chlorhexidine coated silk suture with uncoated silk suture in subjects with stage II and stage III grade B periodontitis undergoing periodontal flap surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects with at least 20 teeth present.
  • Systemically healthy subjects of either sex, not under any medication affecting the periodontal treatment outcome.
  • Subjects with probing pockets depth of ≥ 5mm with atleast 2 teeth and on both sides of the same arch after phase I therapy.
  • Subjects willing to be a part of the study without any objection.

排除标准

  • Subjects with history of antibiotic and/or anti-inflammatory drugs in the past 3 months.
  • Pregnant women, women on oral contraceptive medication and lactating mothers.
  • Subjects who are smokers and/or tobacco chewers.
  • Subjects who have undergone any periodontal therapy in past 6 months.
  • Noncompliant subjects.

结局指标

主要结局

To evaluate the antimicrobial efficacy of chlorhexidine coated silk suture with respect to Colony forming units.

时间窗: Assessed on day 7 after Periodontal flap surgery

次要结局

  • To evaluate the antimicrobial efficacy of chlorhexidine coated silk suture after periodontal flap surgery with respect to(wound healing index)

研究者

发起方
Pandurang Gulabrao Gavhale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pandurang Gulabrao Gavhale

Dr G D Pol Foundations YMT Dental College and Hospital, Kharghar, Navi Mumbai

研究点 (1)

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