跳至主要内容
临床试验/CTRI/2025/03/083026
CTRI/2025/03/083026已完成Phase 3 4

Comparative evaluation of two treatment modalities of minimally invasive non-surgical therapy (minst) with conventional non surgical therapy (cnst) in the treatment of periodontitis

Dr Neha Shukla1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Minimally invasive treatment procedures may prove to be superior in term of healing and patient comfort. Use of Laser together with minimally invasive treatment procedure will have an added advantage in resolution of inflammation and pocket sterilization.

研究概览

简要总结

Periodontitis is considered as a most prevalent condition and it is attributed by loss of attachment, formation of the periodontal pocket and the loss of bony structure. This is one of the major reasons for tooth loss. Factor like dental plaque can cause connective tissue loss with the loss of surrounding bone. Periodontitis has been categorized into various stages, on the basis of severity and also divided into various grades, based on progression of the disease. Reducing the bacterial load of periodontal pocket can be helpful in the treatment of periodontitis and it is attained by periodontal therapy and maintaining the periodontal health. Advanced disease may need surgical intervention or if the prognosis is hopeless, extraction of the involved tooth is advisable. The periodontal therapy can be non-surgical or surgical with the aim to improve clinical attachment, eliminate inflammation and reduce periodontal pocket depth (PD), resulting in decreased risk of progression of disease. Traditional non-surgical periodontal treatment includes, use of power-driven or manual instrumentation to clean the root surfaces. Although there are studies which states that some amount of calculus could be found after traditional therapy and that recession is unavoidable and more in severe cases of periodontitis so recently, minimally invasive non-surgical therapy(MINST) has been proposed to decrease trauma to the tissue and enhance overall outcome by the additional use of magnification and specifically made fine instruments. Magnification can be achieved with the use of loupes, microscopes, videoscopes. Loupes can be of different types based on the magnification range and can be simple or compound and prism in design. Minimally invasive therapy protocol involves the use of 3.5x loupes for magnification. MINST might prove as a good alternate to overcome the limitations of conventional periodontal therapy as, not only magnification but by the use of finer instruments this procedure becomes more effective and less traumatic than conventional treatment.Although, there are only some studies done to assess the efficacy of MINST comparing with the conventional non-surgical therapy in periodontal defects.

Among the newer modalities, lasers in periodontal therapy are becoming common and the outcomes have been reported with overall positive results. Laser assisted minimally invasive non-surgical therapy aims at removal of granulation tissue and debridement without reflection of flap. This is an efficacious approach as a non-surgical treatment. In this study comparative evaluation and assessment between the MINST and Laser assisted MINST would be done among themselves and also with conventional nonsurgical therapy in order to observe superiority of one group over the another.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Systemically healthy patients. 2.Patients with age between 25-55 years 3.Patients diagnosed with generalised periodontitis having Probing depth -5mm and CAL.
  • 3mm and indicated for non surgical periodontal treatment.

排除标准

  • 1.The women who are pregnant/lactating.
  • 2.Patients who required antibiotic treatment.
  • 3.Patients who have taken antibiotic treatment in the last 3 months.
  • 4.Patients who underwent with periodontal therapy in the last 6 months.
  • 5.Patients who have the habit of smoking.

结局指标

主要结局

Minimally invasive treatment procedures may prove to be superior in term of healing and patient comfort. Use of Laser together with minimally invasive treatment procedure will have an added advantage in resolution of inflammation and pocket sterilization.

时间窗: Baseline, 1 month , 3 month , 6 month

次要结局

未报告次要终点

研究者

发起方
Dr Neha Shukla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Neha Shukla

Sardar Patel Post Graduate Institute of Dental and Medical Sciences,

研究点 (1)

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