Comparative evaluation of efficacy of Silver nanoparticle gel versus Chlorhexidine gel as local drug delivery agent in management of Chronic Periodontitis- A split-mouth randomised controlled trial

Dr. Vishakha Chauhan1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2025年7月30日最近更新: 2026年3月10日

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 15
试验地点: 1
主要终点: Following clinical parameters will be assessed-

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

15 Participants visiting the Out patient Department of Periodontology at Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Pune and willing to participate in the study will be selected

After explaining the study design a written informed consent will be obtained from the participants A case history proforma will be designed for this study to ensure the systematic and methodical recording of all information and observations

A detailed case history will be documented

Clinical examination will be conducted on a dental chair under standard lighting conditions using a mouth mirror, explorer, UNC 15 probe and tweezers

Clinical parameters will be assessed accordingly

This is a split mouth technique in which right and left maxillary/mandibular posterior teeth will be allotted to Test or Control group based on simple randomization by coin flipping

This is a triple blinded study in which the patient, investigator and examiner will not be aware of which Local drug delivery agent is used on each side.

Following clinical parameters will be assessed at Baseline, 45 days and 90 days

Gingival Index Loe and Silness 1963
Plaque Index Turesky Gilmore Glickman modification of the Quigley Hein Plaque index 1970
Pocket Probing Depth

Microbiological analysis will be done for anaerobic organisms at Baseline and 90 days

1) Porphyromonas gingivalisaka P. gingivalis

2)Prevotella intermediaaka P. Intermedia

Selected sites will be randomly divided into group A and group B:

Group A or****Control group15 sites will be treated with scaling and root planing followed by placement of Chlorhexidine gel in the periodontal pocket

Group B or****Test group15 sites will be treated with scaling and root planing followed by placement of Silver nanoparticle gel in the periodontal pocket

Sample collection

The area will be isolated using sterile cotton rolls. Subgingival plaque will be scraped using a Gracey curette from the root surface of all teeth included in this study

The collected plaque sample will be transferred into reduced transport fluid and transported immediately for microbiological analysis at Maratha Mandal Dental College Belgaum Karnataka

All standard operating procedures and aseptic protocols will be followed during the collection and transportation of samples

Upon receiving the plaque samples, they will be vortexed properly and cultured on blood agar and PgA agar followed by anaerobic incubation in an anaerobic jar for 48 to 72 hours.

After incubation, the total colony count will be recorded Porphyromonas gingivalis and Prevotella intermedia will be identified based on their colony morphology and their counts will be noted separately

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围: 25.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Subjects willing to participate in the study with written informed consent.
•Systemically healthy subjects Subjects with age between 25 to 60 years Subjects with Chronic Periodontitis having periodontal pockets with probing depth 4 to 6 mm in at least 30 percent sites with bleeding on probing present in mouth.

排除标准

•Subjects who are medically compromised Subjects with any history of allergy to the material used in study Subjects who have undergone any type of periodontal treatment in last 6 months Pregnant and lactating women Subjects on long term administration of inflammatory and immunosuppressive therapy.