| CTRI Number |
CTRI/2025/01/079386 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Which Toothpaste Works Better for Gum Inflammation: One Made with Chitosan vs One Made with Turmeric |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Chitosan based Toothpaste (Conybio Plus™) versus Curcumin based Toothpaste (Purexa™) in Gingivitis Patients -A Randomized 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 Aiswarya Raveendran K |
| Designation |
Second year Postgraduate MDS, Department of Periodontics |
| Affiliation |
Nair Hospital Dental College, Mumbai |
| Address |
Room no.201,Department of Periodontics Nair Hospital Dental
College,Mumbai Maharashtra, 400008 India Mumbai
Mumbai
MAHARASHTRA
400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9497470846 |
| Fax |
|
| Email |
aiswaryaraveendran020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair Hospital Dental College, Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental
College,Mumbai,Maharashtra, 400008 India Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair Hospital Dental College, Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental
College,Mumbai,Maharashtra, 400008 India Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400008
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Aiswarya Raveendran K, Room no. 201, Nair Hospital Dental College, Mumbai, 400008,
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Aiswarya Raveendran K |
| Address |
Room no. 201, Nair Hospital Dental College, Mumbai, 400008,
Maharashtra, India |
| 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 Aiswarya Raveendran K |
Nair Hospital Dental College,Mumbai |
Room 201, department
of Periodontics, second
floor, Nair Hospital
Dental College, Mumbai
Central 400008,
Maharashtra
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9497470846
aiswaryaraveendran020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan based Toothpaste (Conybio Plus™) |
Chitosan based Toothpaste (Conybio Plus™).Total duration of study is 6 months. |
| Comparator Agent |
Curcumin based Toothpaste (Purexa™) |
Curcumin based Toothpaste (Purexa™) .Total duration of study is 6 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group between 20-60 yrs.
2.Patients diagnosed with Gingivitis.
3.Patients who are nonsmokers or do not consume tobacco in any other form. 4.Patients with good systemic health.
|
|
| ExclusionCriteria |
| Details |
1.Individuals wearing fixed or removable orthodontic appliances or prosthesis
2. Pregnant and lactating females.
3. Individuals taking medications since prolonged duration
4. Smokers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (P.I.) (Silness and Loe, 1964)
2. Gingival Index (G.I.) (Loe and Silness, 1963)
|
at baseline (post scaling),
1-month post-scaling. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (P.I.) (Silness and Loe, 1964)
2. Gingival Index (G.I.) (Loe and Silness, 1963)
|
at baseline (post scaling),
1-month post-scaling.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| Date of Study Completion (India) |
05/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
| Introduction Gingival and periodontal diseases are some of the most prevalent chronic oral conditions affecting large populations worldwide. Gingivitis, caused by the buildup of dental plaque, typically occurs before periodontitis, which can eventually result in tooth loss. A direct correlation has been shown between plaque levels and the severity of gingivitis. The etiology of periodontal diseases is dental plaque. Dental plaque is composed of microbial biofilms that adhere to the tooth surface.The susceptibility of an individual to develop periodontal diseases depends on the immune and inflammatory responses to the periodontopathogenic bacteria present in the dental plaque and is modified by environmental factors. | Periodontal disease initially begins as gingivitis, which is the most common reversible gum disease characterized by inflammation of marginal and attached gingiva in response to the dental plaque. When dental plaque is left to accumulate, gingivitis may progress to periodontitis, which is the irreversible destruction of the underlying connective tissue and alveolar bone. | Curcumin reduces inflammation in the gums and exhibits antimicrobial effects against harmful bacteria, helping to alleviate symptoms and lower bacterial load in periodontitis. It inhibits osteoclast activity, potentially preserving the alveolar bone structure often affected by chronic periodontitis. It promotes tissue repair and regeneration while neutralizing free radicals, protecting gum tissues from oxidative stress and supporting recovery after periodontal treatments. | The main objective of the study is to compare the and evaluate the efficacy of Chitosan based Toothpaste (Conybio PlusTM) with Curcumin based Toothpaste (PurexaTM) in Gingivitis Patients.Aims and Objectives
To clinically compare and evaluate the efficacy of Chitosan based Toothpaste (Conybio PlusTM) with Curcumin based Toothpaste (PurexaTM) in Gingivitis Patients.
Materials and methods
A total of 60 patients for this study will be selected from outpatient department of PeriodonticsThe patients selected as per the inclusion and exclusion criteria, will be randomly allotted by a computerized automated randomization method into 2 groups, Group A and Group B, and treated as follows Group A: Scaling and root planing followed by Chitosan based toothpaste Conybio PlusTM. | GroupB: Scaling and root planing followed by Curcumin based toothpaste PurexaTM |