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临床试验/CTRI/2024/05/067602
CTRI/2024/05/067602尚未招募3 期

TO COMPARE AND ASSESS THE CLINICAL PARAMETER AND ANTIMICROBIAL EFFICACY OF SCALING & ROOT PLANING ALONE AND CHLORHEXIDINE GEL AND GREEN COFFEE BEAN EXTRACT GEL AS ADJUNCT TO SCALING & ROOT PLANING AGAINST P.GINIGIVALIS IN STAGE 2 PERIODONTITIS PATIENTS A CLINICO BIOCHEMICAL STUDY

Dr. ANISHA KORIKANI1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年6月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
13
试验地点
1
主要终点
Assessment of Antimicrobial efficacy of green coffee bean extract gel and chlorhexidine gel as an adjunct to scaling & root planing against P.gingivalis in stage 2 periodontitis patients

研究概览

简要总结

This study is designed to be a split mouth study where 13 patients of both the gender with stage 2 periodontitis, satisfying all the inclusion criteria will be enrolled for the study . The total sample size calculated is 13 patients , further randomly divided in 3 groups/Quadrants with 39 sites in total. `The quadrant will be allocated using computerized randomization method and is treated by scaling & root planing alone, scaling & root planing with commercial available chlorhexidine gel  and  green coffee bean extract gel as an adjunct to scaling & root planing.

The assessment will be carried out as:

Group A- Scaling and root planning alone.

Group B- Scaling and root planing with chlorhexidine gel  as an adjunct.

Group C- Scaling and root planning with green coffee bean extract gel as an adjunct.

Subgingival plaque sample collection will be done at baseline and 3 months after the therapy.

The demographic characteristics of the patients (age & sex),Clinical parameters such as Probing pocket depth (PPD), clinical attachment level (CAL), Plaque index (PI), Gingival Index (GI), Bleeding on probing (BOP) will also be recorded at base line and at 3 months after periodontal therapy

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • Subjects who are diagnosed with clinical stage 2 periodontitis, with probing depth greater than or equal to 5mm in at least 3 quadrants and willing for treatment.
  • Patients with age range of 25-55 years are included in the study and comprises of both sexes.
  • Minimum of 15 teeth should be remaining.

排除标准

  • Patients with systemic diseases such as diabetes mellitus, cardiovascular disorder, immunologic disorders, hepatitis and human immunodeficiency virus infections.
  • Pregnant and lactating women and those taking oral contraceptive drugs.
  • Subjects who had received antibiotics or treatment for periodontal disease in the 6 months.
  • Steroid or inflammatory drugs for 7 days in 3 months.
  • Known allergy to the above mentioned drugs/substance.
  • Smokers and alcoholic.

结局指标

主要结局

Assessment of Antimicrobial efficacy of green coffee bean extract gel and chlorhexidine gel as an adjunct to scaling & root planing against P.gingivalis in stage 2 periodontitis patients

时间窗: All clinical parameters will be measured and | Subgingival plaque sample collection will be done at baseline and 3 months after the therapy. | Gel application will be done at baseline

次要结局

  • To compare clinical parameter and Antimicrobial efficacy between scaling & root planing group ,chlorhexidine gel and green coffee bean extract gel as an adjunct to scaling and root planing against P. gingivalis in stage 2 periodontitis patients(All clinical parameters will be measured and)

研究者

发起方
Dr. ANISHA KORIKANI
申办方类型
Other [Other (Self)]
责任方
Principal Investigator
主要研究者

Anisha Korikani

Coorg institute of dental sciences

研究点 (1)

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