CTRI

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CTRI Number

CTRI/2025/07/090084 [Registered on: 02/07/2025] Trial Registered Prospectively

Last Modified On:

10/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Silver Nanoparticle vs Chlorhexidine Gel for treatment of Gum Disease

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vishakha Chauhan
Designation	MDS Part 1
Affiliation	Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Pune- 411043
Address	Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Dhankawadi Katraj Pune MAHARASHTRA 411043 India
Phone	9521560254
Fax
Email	chauhanvishakha23@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Pooja Pharne
Designation	Associate Professor
Affiliation	Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Pune- 411043
Address	Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Dhankawadi Katraj Pune MAHARASHTRA 411043 India
Phone	8459405533
Fax
Email	pooja.pharne@bharatividyapeeth.edu

Details of Contact Person
Public Query

Name	Dr Vishakha Chauhan
Designation	MDS Part 1
Affiliation	Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Pune- 411043
Address	Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Dhankawadi Katraj Pune MAHARASHTRA 411043 India
Phone	9521560254
Fax
Email	chauhanvishakha23@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr. Vishakha Chauhan
Address	Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Dhankawadi Katraj Pune 411043
Type of Sponsor	Other [Primary Investigator]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vishakha Chauhan	Bharati Vidyapeeth Deemed to be University Dental College	Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Dhankawadi Katraj Pune 411043 Pune MAHARASHTRA	9521560254 chauhanvishakha23@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee of Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital Pune	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Generalised Chronic Periodontitis

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Chlorhexidine gel	15 sites will be treated with scaling and root planing followed by placement of Chlorhexidine gel that is Hexigel in the periodontal pocket
Intervention	Silver nanoparticle gel	15 sites will be treated with scaling and root planing followed by placement of Silver nanoparticle gel that is Megaheal gel in the periodontal pocket

Inclusion Criteria

Age From	25.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	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

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Following clinical parameters will be assessed- Gingival Index Loe and Silness 1963 Plaque Index Turesky-Gilmore-Glickman modification of the Quigley–Hein Plaque index 1970 Pocket Probing Depth reduction Microbiological analysis will be done for anaerobic organisms at Baseline and 90 days for Porphyromonas gingivalis and Prevotella intermedia	Clinical parameters will be assessed at Baseline, 45 days and 90 days Microbiological parameters will be assessed at Baseline and 90 days

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 4

Date of First Enrollment (India)

30/07/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

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

1) Gingival Index Loe and Silness 1963

2) Plaque Index Turesky Gilmore Glickman modification of the Quigley Hein Plaque index 1970

3) Pocket Probing Depth

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

1) Porphyromonas gingivalis aka P. gingivalis

2) Prevotella intermedia aka P. Intermedia

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

Group A or Control group 15 sites will be treated with scaling and root planing followed by placement of Chlorhexidine gel in the periodontal pocket

Group B or Test group 15 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