CTRI

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CTRI Number

CTRI/2025/06/088014 [Registered on: 02/06/2025] Trial Registered Prospectively

Last Modified On:

07/05/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Antimicrobial Irrigation ]

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Flushing of the gum pockets with anti-microbial and anti-septic solutions to reduce the amount of micro-organisms growth.

Scientific Title of Study

Evaluating the efficacy of 0.25% Sodium Hypochlorite and 0.2% Chlorhexidine Digluconate as pocket irrigants and adjuncts to scaling and root planing in retarding the recolonization rates of Aggregatibacter Actinomycetemcomitans and Porohyromonas Gingivalis in stage II Grade B Periodontitis patients-A Randomized 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	Ankitha S
Designation	Post Graduate
Affiliation	Sharavathi Dental College
Address	Sharavathi Dental College and Hospital Department of periodontology Room No-7 Sharavathi Dental College and Hospital. Department of periodontology Room No -7 Shimoga KARNATAKA 577205 India
Phone	07204765405
Fax
Email	ankitharaj21@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Soumya
Designation	Professor
Affiliation	Sharavathi Dental College and Hospital
Address	Department of Periodontology Sharavathi Dental College And Hospital Sharavathi Dental College and Hospital. Shimoga KARNATAKA 577205 India
Phone	9886120257
Fax
Email	drbgsoumya@gmail.com

Details of Contact Person
Public Query

Name	Dr Soumya
Designation	Professor
Affiliation	Sharavathi Dental College and Hospital
Address	Department of Periodontology Sharavathi Dental College And Hospital Sharavathi Dental College and Hospital. Shimoga KARNATAKA 577205 India
Phone	9886120257
Fax
Email	drbgsoumya@gmail.com

Source of Monetary or Material Support

Sharavathi Dental College and Hospital

Primary Sponsor

Name	Sharavathi Dental College and Hospital
Address	Sharavathi Dental College and Hospital NH 205 TH Road Alkola Shivamogga 577205
Type of Sponsor	Research institution and hospital

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
Ankitha S	Sharavathi Dental College and Hospital	Sharavathi Dental College and Hospital. Department of periodontology Room No -7 Shimoga KARNATAKA	07204765405 ankitharaj21@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sharavathi Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: B998\|\|Other infectious disease,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Chlorhexidine 0.2%	Chlorhexidine 0.2% in 5ml syringes to be used for irrigation of periodontal pockets
Intervention	Distilled water	Distilled water in 5ml syringes to be used for irrigation of periodontal pockets.
Intervention	Sodium Hypochlorite 0.25%	Sodium Hypochlorite 0.25% in 5 ml syringes to be used for irrigation of periodontal pockets.
Intervention	Subgingival irrigation	Sodium Hypochloride 0.25%, Chlorhexidine 0.2% and distilled water shall be loaded into 5ml syringes. this quantity shall be irrigated into the periodontal pocket of each tooth. % ml utilised for each tooth.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	79.00 Year(s)
Gender	Both
Details	Signs of gingival inflammation. Bleeding on probing.

ExclusionCriteria

Details

Antibiotics within 3 months prior to sample collection.
Pregnant and lactating women.
Tobacco users.
Presence of diabetes or other systemic illnesses.

Method of Generating Random Sequence

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

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
reduced numbers of micro-organisms checked at baseline, i.e. aggregatibacter actenomycetemcomitans and Porphyromonas gingivalis.	The sample to evaluate the above will be collected at baseline and 60th day.

Secondary Outcome

Outcome	TimePoints
Plaque Index (PI) , Gingival Index (GI), Gingival Bleeding Index, Pocket probing depth (PPD)	Baseline and 60th Day

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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

N/A

Date of First Enrollment (India)

01/07/2025

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)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

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

Patients suffering from stage II grade B periodontitis will be selected from the outpatient department of Periodontics of the Institution.

Clinical parameters recorded will include:

Plaque Index (PI) by Sillness and Loe,

Gingival Index (GI) by Loe and Sillness,

Gingival Bleeding Index by Ainamo & Bay,

Pocket probing depth (PPD) recorded with an UNC 15 probe.

All the clinical parameters will be measured at baseline and 60^th day.

Subgingival samples are collected at baseline and on the 60th day for all the patients. All patients undergo scaling and root planing. Patients will be randomly allocated to the two experimental and control groups.