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临床试验/NCT03882138
NCT03882138已完成不适用

Clinical Evaluation of Influence of Gingival Biotype on the Outcome of Open Flap Debridement in Patients With Chronic Periodontitis- An Interventional Study

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017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
40
试验地点
2
主要终点
clinical attachment level

研究概览

简要总结

The influence of periodontal thickness has been documented in outcome of various periodontal interventions like non surgical periodontal therapy, mucogingival therapy, guided tissue regeneration (GTR), crown lengthening and implant dentistry. There is lack of study showing the influence of gingival biotype on outcome of surgical procedure. The present study is therefore undertaken to evaluate the influence of gingival biotype on the outcome of open flap debridement for treatment 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. Chronic periodontal disease can be successfully treated by non-surgical or surgical mechanical therapy provided adequate plaque control is maintained during the supportive phase of treatment. Elimination of these pockets by the therapist is necessary to allow the patient better access for plaque control. The goal of periodontal therapy, therefore, should include the creation of an oral environment in which the patient can cleanse every surface of every tooth. Ideally, this would be best accomplished by complete regeneration of the lost attachment apparatus and reestablishment of a minimal depth of sulcus.

It is seen that in pockets with shallow probing depths(1-3mm), there is reduction of pocket depth and loss of attachment by all the treatment modalities and more following surgical treatment. Lindhe et al. (1982) defined a critical probing depth below which the nonsurgical therapy is most likely to lead to loss of probing attachment In sites with moderate probing depth (4-6mm), there is more pocket reduction following MWF than subgingival curettage and SRP. Attachment gain is seen following all techniques and more following modified widman flap (MWF).

Deep pockets(>7mm) have shown reduction in probing depth following all the treatment modalities but more reduction is seen following MWF. More gain in attachment is seen following MWF than subgingival curettage.

Ramfjord observed an increase in pocket depth following periodontal treatment in shallow pockets. He also found loss of attachment with surgical therapy in moderate probing depth.

Histological findings in humans have revealed that there is loss of crestal bone as a consequence of periodontal surgical treatment. The resorption pattern varied with thickness of connective tissue covering the bone and was modified by injury to bone due to contact or near contact during instrumentation. Measurement indicated resorption occurs if retained tissue is 0.45 mm or less.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patients with moderate to severe chronic periodontitis
  • Age 25-55 years
  • Clinical attachment loss(CAL) ≥3 mm
  • Probing pocket depth (PPD) ≥5 mm
  • Possessing ≥20 natural teeth.

排除标准

  • Patients with vertical bone loss
  • Current or former smokers or use of tobacco in any form
  • Pregnant women, lactating mothers and women taking oral contraceptives
  • Patient who had undergone periodontal treatment within 6 months prior to the study
  • 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
  • Patient with average plaque index ≥1.5 after phase 1 therapy
  • Miller Grade II /Grade III tooth mobility after SRP
  • Periapical infection in any tooth of the surgical treatment segment.

研究组 & 干预措施

thin biotype

Active Comparator

Modified Widman flap surgery followed by meticulous debridement, root planning and thorough irrigation with normal sterile saline solution

干预措施: open flap debridement (Procedure)

thick biotype

Active Comparator

Modified Widman flap surgery followed by meticulous debridement, root planning and thorough irrigation with normal sterile saline solution

干预措施: open flap debridement (Procedure)

结局指标

主要结局

clinical attachment level

时间窗: 6 months

clinical attachment level is measured from cementoenamel junction to base of pocket

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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