| CTRI Number |
CTRI/2025/10/095567 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Amla and Melatonin Gum Paint on Gum Health in Gingivitis |
|
Scientific Title of Study
|
Evaluation of effectiveness of gum paint containing emlica officinalis and melatonin in patients with Gingivitis.- A 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 SUREKHA RATHOD |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY. RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR. |
| Address |
RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SUREKHA RATHOD |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR. |
| Address |
RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SUREKHA RATHOD |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR. |
| Address |
RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR.
Nagpur MAHARASHTRA 440019 India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Nagpur, India -440019 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Type of Sponsor |
Other [] |
|
|
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 SUREKHA RATHOD |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
Department of Periodontics and Implantology
Digdoh Hills Hingna
road Nagpur:440019
MAHARASHTRA, INDIA Nagpur MAHARASHTRA |
9011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with Gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NSPT |
Scaling and root planning |
| Intervention |
NSPT + Gum Paint |
Commercially available to be applied once daily |
| Intervention |
NSPT + Gum paint |
Gum paint conatining Emblica Officinalis and Melatonin to be applied once daily |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in the age range from 15 to 45 years
2. Those who have gingivitis having PPD greater than 4 mm |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone any periodontal therapy in the past 6 months
2. Patients with systemic diseases
3. History of any medication including antibiotic treatment within the previous 3
months or regular use of specific drugs known to affect periodontal tissues
4. Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and Compare Gum Paint Containing Emblica Officinalis and Melatonin in patients with Gingivitis |
At baseline and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="0" Months="6" 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
|
Gingivitis is a common and mild form of periodontal disease characterized by inflammation of the gingiva, the part of the gum that surrounds the base of the teeth. It is most often caused by poor oral hygiene, which leads to the accumulation of dental plaque, a sticky biofilm composed of bacteria on the tooth and gums. If not removed through regular brushing and flossing, this plaque hardens into tartar, further irritating the gums and triggering an inflammatory response. Clinically, gingivitis presents with symptoms such as redness, swelling, tenderness of the gums, and bleeding during brushing and flossing. Long-term studies have shown that persistent gingival inflammation significantly increases the risk of attachment loss and tooth loss. Preventive strategies such as routine oral hygiene, regular dental check-ups, and patient education are essential for its management and for preventing its progression to more serious periodontal diseases.
Amalaki, commonly known as amla or Indian gooseberry, is a highly valued herb in traditional Ayurvedic medicine and has been used for centuries for its wide range of therapeutic benefits. In oral health, amla has shown significant promise due to its astringent and antimicrobial properties. It helps tighten the gums, reduce bleeding, and combat infections, making it a valuable component in gum paint formulations.
Melatonin (N-acetyl-5-methoxytryptamine) has shown promising therapeutic potential in oral health. Its antioxidant properties allow it to neutralize reactive oxygen species (ROS), which are commonly elevated in inflammatory conditions like gingivitis and periodontitis. In dental applications, melatonin plays a role in enhancing osseointegration of dental implants, accelerating wound healing after extractions, and mitigating the cytotoxic effects of dental materials.
Gum paints available in the market and commonly used in gingivitis treatment for their antimicrobial properties are often synthetically prepared and may cause side effects such as skin irritation, dryness, and allergic reactions. These drawbacks highlight the need for safer alternatives.
In response, this study explores a novel gum paint formulation using melatonin and amla, natural agents known for their antioxidant, antiseptic, and antibacterial properties.
So the aim of the study is to evaluate the effectiveness of gum paint containing Emblica officinalis and melatonin in patients with gingivitis. |