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临床试验/CTRI/2025/02/081311
CTRI/2025/02/081311尚未招募4 期

A COMPARATIVE EVALUATION OF OXYGEN RELEASING ORAL GEL AND 0.8 PERCENTAGE HYALURONIC ACID GEL IN THE TREATMENT OF CLASS II FURCATION DEFECTS A CLINICO – RADIOGRAPHIC STUDY

Dr PAVITRA JAYAKUMAR1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年10月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
1. Plaque Index (PI)

研究概览

简要总结

· Periodontitis is a complex multifactorial disease, characterized by clinical attachment loss (CAL) and formation of osseous deformities, including furcation and intra bony defects.

· The furcation can be defined as the anatomic area of a multirooted tooth in which the roots diverge. Furcation invasion or involvement is the result of pathologic resorption of the supporting alveolar bone within a furcation, typically derived from the progression of chronic or aggressive periodontitis.

· Molar furcation involvement is one of the most common dento-alveolar sequelae of periodontal disease. The application of a specific treatment method for furcation involvement requires a thorough understanding of tooth anatomy, etiologic factors, and the biologic basis for treatment modalities.

· Oxygen releasing oral gel has the particularity to release oxygen at a therapeutic concentration in the affected tissues. The therapeutic effects of blue m gel are neovascularization, removal of toxins, stimulation and formation of new blood cells, increasing the production of stem cells, which leads to more rapid healing, antibacterial effect, antihistamine effect, antimycotic effect.

· Hyaluronic acid (HA) maintains cell viability, and increases proliferation and early osteogenic differentiation.

· HA accelerates cell differentiation and migration during tissue formation and repair process has been utilized in non-surgical periodontal therapy, peri-implantitis management, root coverage procedures, management of furcation involvement, and socket preservation.

Thus, this the kind of first study to assess the efficacy of oxygen releasing oral gel and hyaluronic acid gel in the treatment of Class II Furcation Defect.

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 and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects with Chronic Periodontitis with Grade II furcation defects with horizontal defect of atleast 3 mm in mandibular molars.
  • Individuals with good general health and with no systemic diseases like diabetes, bleeding disorders, hypertension, allergic reaction, cardio-vascular diseases were recruited to participate in this study.
  • Patients of both sexes between the age group of 30 – 50 years .
  • Teeth with functional antagonist were included.

排除标准

  • 未提供

结局指标

主要结局

1. Plaque Index (PI)

时间窗: BASELINE AND 6 MONTHS

2. Gingival Index (GI)

时间窗: BASELINE AND 6 MONTHS

3. Probing pocket depth (PPD).

时间窗: BASELINE AND 6 MONTHS

4. Relative vertical clinical attachment level (RV-CAL)

时间窗: BASELINE AND 6 MONTHS

5. Relative horizontal clinical attachment level (RH-CAL)

时间窗: BASELINE AND 6 MONTHS

次要结局

  • 1. Plaque Index (PI)(2. Gingival Index (GI))

研究者

发起方
Dr PAVITRA JAYAKUMAR
申办方类型
Other [SELF ]

研究点 (1)

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