跳至主要内容
临床试验/CTRI/2024/11/076561
CTRI/2024/11/076561
尚未招募
1 期

A Single Blind, Single center, Pilot clinical study to evaluate the safety and Comparative Evaluation of Conventional Therapy With and Without Use of AURIBUR, a soft dental bur for periodontal pocket curettage in the Treatment of Periodontitis: A Randomised split mouth trial.

Aur Innovations Prrivate Limited2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年12月19日最近更新:

概览

阶段
1 期
状态
尚未招募
发起方
Aur Innovations Prrivate Limited
入组人数
36
试验地点
2
主要终点
- Reduced Gingival Inflammation And Swelling.

概览

简要总结

Periodontitis is the one among the most commonly reported oral disease in the human population. It is a polymicrobial disease, involving destruction of supporting tissues of the teeth which leads to pocket formation, loss of alveolar bone, mobility of teeth, thus eventually causing loss of dentition. This disease in turn affects the quality of life of the people. For decades, open flap debridement is considered the standard treatment protocol for management of chronic periodontitis. Despite its success rate, recurrence of the disease still exists. This is because of the nature of the anaerobic periodontal pathogens which are tissue invading and capable of releasing virulence factors that evades the host immune mechanism.

There is a requirement of cost effective quality based treatment for patients who are unwilling to do other Conventional therapy like periodontal flap surgery, etc., for periodontitis in conjunction with patient education, oral hygiene improvement, scaling and root planing, and frequent recall maintenance.

This research is required to Evaluate and compare the Conventional Therapy With and Without Use of AURIBUR, a soft dental bur for periodontal pocket curettage in the Treatment of  Periodontitis

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Male Or Female Above 18 Yrs of age Periodontal lesions with pocket probing depth, PPD more than 5mm Have at least Two natural teeth excluding third molars.
  • Provide Informed consent and willingness to cooperate with the study protocol.

排除标准

  • Treatment with blood thinner drugs Diseases such as HIV/AIDS, chronic renal failure, ,bleeding disorder and autoimmune diseases Patient who require antibiotic prophylaxis before examination or treatment Patient with some mental disability.
  • intraoral soft tissue or hard tissue pathosis.
  • Systemic condition contraindicating periodontal therapy Healthy gingiva and periodontium, Patient with psychiatric problems, Simultaneous participation in any other clinical study.

结局指标

主要结局

- Reduced Gingival Inflammation And Swelling.

时间窗: - At Baseline | - 2 Weeks | - 4 weeks

- Periodontal Pocket Depth reduction.

时间窗: - At Baseline | - 2 Weeks | - 4 weeks

- evaluation of the safety of newly advanced Flexible Plastic Bur ( AURIBUR ) for periodontal pocket curettage in the Treatment of Periodontitis

时间窗: - At Baseline | - 2 Weeks | - 4 weeks

- Evaluation and comparison of the Conventional Therapy With and Without Use of AURIBUR, a soft dental bur for periodontal pocket curettage in the Treatment of Periodontitis

时间窗: - At Baseline | - 2 Weeks | - 4 weeks

次要结局

  • evaluation and comparison of clinical parameters with combined efficacy of Auribur as an adjunct to scaling and root planing(Evaluation of combined efficacy of Auribur, a soft flexible Dental Bur for periodontal pocket curettage, as an adjunct to scaling and root planing on improving the Probing depth (PD), Clinical attachment level (CAL), Plaque Index (PI) and Gingival Index (GI).)

研究者

发起方
Aur Innovations Prrivate Limited
申办方类型
Other [Medical Device Company]
责任方
Principal Investigator
主要研究者

Dr Esha Jaiswal

Multispeciality Dental Clinic

研究点 (2)

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