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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  
Name  Address 
None  None 
 
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  
Status 
Not Applicable 
 
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.

 
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