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临床试验/NCT03914339
NCT03914339Unknown不适用

"EFFECT OF ORTHODONTIC TREATMENT ON PERIODONTAL HEALTH OF PERIODONTALLY COMPROMISED DENTITION- A Prospective Randomized Controlled Clinical Trial"

Postgraduate Institute of Dental Sciences Rohtak4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018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
入组人数
36
试验地点
4
主要终点
• Alveolar crest bone level

研究概览

简要总结

The main aim of this prospective, randomized controlled clinical study is to:

• To evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.

详细描述

All the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. This will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. After an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.Changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam Computed tomography will be taken at the baseline T0 and study end point T2 for assessment of changes in the bone level around maxillary and mandibular teeth

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Systemic illness known to affect the periodontium or outcome of periodontal and orthodontic therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Pregnant or lactating women.
  • Smokers(≥5 cigarettes∕ day).
  • Noncompliance to oral hygiene measures after Phase I therapy.
  • Presence of trauma from occlusion (TFO).
  • Patients with aggressive periodontitis

研究组 & 干预措施

Test group

Experimental

Eighteen periodontally compromised patients who will be given both orthodontic and periodontal treatment .

干预措施: Periodontal and orthodontic treatment (Procedure)

control group

Active Comparator

Eighteen periodontally compromised patients will receive periodontal treatment alone .

干预措施: periodontal treatment (Procedure)

结局指标

主要结局

• Alveolar crest bone level

时间窗: 12 months

measured from Cemento- enamel junction to bone crest.

Clinical attachment level (CAL).

时间窗: 12 months

• pocket to cemento- enamel junction .

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 (4)

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