| CTRI Number |
CTRI/2026/02/105012 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare a new chlorophyllin based gel with chlorhexidine gel as an additional treatment for patients suffering with gum disease |
|
Scientific Title of Study
|
Clinical evaluation of a novel sodium copper chlorophyllin loaded cubosomal in situ gel compared to chlorhexidine gel as an adjunct to scaling and root planing in the treatment of stage 2 grade A periodontitis: a randomized controlled clinical 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 Prisha Sumedha Reddy Sarella |
| Designation |
post graduate student |
| Affiliation |
KLE VK Institute of dental sciences |
| Address |
Department of periodontics
KLE VK Institute of dental sciences
Nehru nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7799213283 |
| Fax |
|
| Email |
prishasumedha1912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelamma A Shetti |
| Designation |
Reader |
| Affiliation |
KLE VK Institute of dental sciences |
| Address |
Department of periodontics
KLE VK Institute of dental sciences
Nehru nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7799213283 |
| Fax |
|
| Email |
neelushetti1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prisha Sumedha Reddy Sarella |
| Designation |
post graduate student |
| Affiliation |
KLE VK Institute of dental sciences |
| Address |
Department of periodontics
KLE VK Institute of dental sciences
Nehru nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7799213283 |
| Fax |
|
| Email |
prishasumedha1912@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prisha Sumedha Reddy Sarella |
| Address |
Department of Periodontics, KLE VK Institute of Dental Sciences, Belagavi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prisha Sumedha Reddy Sarella |
KLE VK Institute of dental sciences |
Department of Periodontics
Belgaum
KARNATAKA |
7799213283
prishasumedha1912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethical Committee KLE VKIDS NECRBHR, DHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with stage 2 grade A periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gel |
participants in the control group will receive full mouth ultrasonic scaling and root planing followed by subgingival delivery of chlorhexidine gel into periodotal pockets as a single local application using a syringe |
| Intervention |
Sodium copper chlorophyllin loaded cubosomal in situ gel |
Participants in the test group will receive full mouth ultrasonic scaling and root planing followed by subgingival delivery of 0.25 percent sodium copper chlorophyllin loaded cubosomal in situ gel into periodontal pockets. The gel will be administered as a single local application using a syringe for targeted delivery |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
untreaded stage 2 grade A periodontitis
probing depth less than 5mm with bleeding on probing
minimum 20 natural teeth present
systemically healthy individuals
willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
pregnant or lactating women
medically compromised patients
periodontal therapy within the last 6 months
smokers and former smokers
known allergy to study materials
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in pocket probing depth from baseline to 14 days |
Baseline
7 days
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in gingival index Loe and Silness from baseline to 14 days |
baseline
7 days
4 days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This randomized double blinded controlled clinical trial aims to evaluate the clinical efficacy of sodium copper chlorophyllin loaded cubosomal in situ gel compared to chlorhexidine gel as an adjunct to scaling and root planing in patients diagnosed with stage 2 grade A periodontitis. 48 systemically healthy patients will be randomly allocated into two groups. Clinical parameters including pocket probing depth and gingival index will be assessed at baseline 7 days and 14 days. The study aims to determine whether sodium copper chlorophyllin gel provides clinical improvement compared to chlorhexidine gel. |