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临床试验/NCT03556163
NCT03556163已完成不适用

Use of Modified Vertical Internal Mattress Suture Versus Simple Loop Interrupted Suture in Modified Widman Flap Surgery- A Randomized Clinical Study.

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Clinical Attachment Level

研究概览

简要总结

Aim of study was clinical comparative evaluation of using modified vertical internal mattress suturing technique and simple loop interrupted suturing technique in the outcome of modified Widman flap surgery for the management of chronic periodontitis.

详细描述

Periodontitis is inflammation of the periodontal tissues resulting in clinical attachment loss, alveolar bone loss, and periodontal pocketing.The destruction of tooth supporting tissues is caused by interaction of bacteria present in the dental plaque and the host .The elimination of bacterial plaque, calculus ,toxic material adhering to tooth surface and other plaque retentive factors can be achieved by nonsurgical and surgical periodontal therapies .The primary objective of periodontal therapy is arresting infection, restoring the lost structure and to maintain healthy periodontium .

The requirement of access for scaling and root planning, pocket depth reduction, correction of gross gingival aberrations ,and establishment of morphology of the dento-gingival area conducive to infection control led to the development of the various surgical procedures. The initial surgical procedures used in periodontal therapy involved excision of the diseased gingival tissue . The main disadvantages of these procedures are unwanted root exposure, poor aesthetics, decrease in width of attached gingiva, excision of frenum attachment and creation of shallow vestibular depth.

Proper management of supracrestal soft tissue flap during suturing appears to be of critical importance in ultimate outcome of surgical periodontal pocket management .A number of studies advocate the proper management of supra-alveolar component of flap in management of infrabony defects employing regenerative techniques with grafts / barrier membrane to minimize postoperative exposure, contamination and/or exfoliation of the grafted material and / or barrier membrane. However review of the available literature does not reveal studies conducted to evaluate the effectiveness of close approximation of flaps by different suturing techniques. Sites with suprabony periodontal pocket depth of 4mm have approximately 6 mm height of unsupported supracrestal soft tissue flap which increases with further increase in pocket depth. Moreover, with advancing probing depth, base of the unsupported soft tissue wall of periodontal pocket comes closer to the musculature in the vestibule, thereby eliciting requirement of a more efficient suturing technique to resist muscle pull for prevention of any disturbance to healing granulation tissue.

The interrupted suturing encompasses two suturing technique; the simple loop and figure of eight. Modified vertical internal mattress suture is a variation of the vertical mattress suture which is especially useful in maximizing wound eversion, reducing dead space, and minimizing tension across the wound. Wound eversion maximize flap approximation. The recommended time for removal of this suture is 5-7 days to reduce the risk of scarring (cross hatching).

Thus the most suitable suturing technique to achieve healing by primary intention and connective tissue reattachment/ periodontal regeneration need to be explored. The present study is intended to determine the influence of the simple interrupted and modified vertical internal mattress suturing technique on the outcome of modified Widman flap surgery .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 52 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Systemically healthy individual possessing ≥20 natural teeth.
  • •Chronic periodontitis criteria as defined by division of Oral health at the centre for Disease Control and Prevention (CDC) in collaboration with American Academy of Periodontology (AAP) 42 (Page and Eke 2012) i.e.at least two or more interproximal sites with clinical attachment loss(CAL)≥4 mm (not on the same tooth),or ≥2 interproximal sites with probing pocket depth (PD)≥5 mm (not on the same
  • •Residual pocket depth ≥4 mm after phase 1 therapy for surgical intervention.

排除标准

  • •Patients with vertical bone loss.
  • •Current or former smokers or use of tobacco in any form.
  • •Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing such as statins, glucocorticoids, phenytoin, calcium channel blockers, immunosuppressants, bisphosphonates or any other host modulatory drug within six months of commencement of study.
  • •Pregnant women, lactating mothers and women taking oral contraceptives.
  • •Patient who had undergone periodontal treatment within 6 months prior to the study.
  • •Patient with average plaque index ≥1.5 after phase 1 therapy.
  • •Miller Grade II /III tooth mobility after phase 1 treatment.
  • •Periapical infection in any tooth of the surgical treatment segment.

研究组 & 干预措施

Test Group

Experimental

Modified vertical internal mattress sutures + MWF surgery.

干预措施: Modified vertical internal mattress sutures + MWF surgery. (Procedure)

Control Group

Active Comparator

Simple loop interrupted sutures + MWF surgery.

干预措施: Simple loop interrupted sutures + MWF surgery. (Procedure)

结局指标

主要结局

Clinical Attachment Level

时间窗: 6 months

CAL was recorded from cementoenamel junction to base of pocket.

次要结局

  • Bleeding on probing(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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