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CTRI Number  CTRI/2026/01/101396 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   "Comparative Clinical Trial of 2% Curcumin Gel, 99% Aloe Vera Gel, and 1% Chlorhexidine Gel in Treating Stage II Grade B Periodontitis" 
Scientific Title of Study   Comparative evaluation of clinical efficacy of 2 percent curcumin gel 99 percent aloevera extract gel and 1 percent chlorhexidine gel as local drug delivery in Stage II Grade B periodontitis patients A Single blind 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 Namrata Diliprao Adhau 
Designation  PG Student  
Affiliation  MGVs KBH Dental College and Hospital ,Nashik 
Address  301 Second floor Dept of Periodontology MGVs KBH Dental College and Hospital Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8766701585  
Fax    
Email  namratadiliprao15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Triveni Kale 
Designation  Professor PG Guide  
Affiliation  MGVs KBH Dental College and Hospital ,Nashik 
Address  301 Second floor Dept of periodontology panchavati nashik

Nashik
MAHARASHTRA
422003
India 
Phone  8552011711  
Fax    
Email  triv19792018@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrNamrata Diliprao Adhau 
Designation  1st MDS 
Affiliation  MGVs KBH Dental College and Hospital ,Nashik 
Address  At.Post.Taroda , Tq.Morshi , Dist. Amravati Pin Code 444905
At.Post.Taroda , Tq.Morshi , Dist. Amravati Pin Code 444905
Amravati
MAHARASHTRA
444905
India 
Phone  8380812536  
Fax    
Email  namratadiliprao15@gmail.com  
 
Source of Monetary or Material Support  
Dr.Namrata Adhau MGVs KBH Dental College and Hospital,panchavati,Nashik,Maharashtra,India.422003 
 
Primary Sponsor  
Name  Dr Namrata Diliprao Adhau 
Address  MGVs KBH Dental College and Hospital,panchavati,Nashik,Maharashtra,India.422003 
Type of Sponsor  Other [Self] 
 
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 
Dr Namrata Adhau  MGVs KBH Dental College and Hospital Nashik  303,Department of Periodontology and Oral Implantology
Nashik
MAHARASHTRA 
8380812536

namratadiliprao15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KBH DENTAL COLLEGE - INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1.0% Chlorhexidine gel  Gold standard ingredient used to treat stage II grade B periodontitis 
Intervention  2% curcumin gel, 99% aloevera extract gel   Natural ingredients used to treat stage II grade B periodontitis 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Patients within age group of 18- 45 years with Stage II Grade B periodontitis.
2. Patients with residual probing pocket depth of 3-4 mm after 4 weeks of scaling and root planing will be selected for the study.
3. Patients who have not undergone any periodontal therapy 6 months before the initial examination.
 
 
ExclusionCriteria 
Details  1. Smokers and tobacco chewer.
2. Patients on antibiotics one month prior to treatment.
3. Patients using orthodontic or prosthodontic appliances either fixed or removable.
4. Patients who have used oral gels or mouthwash containing chemical agents in previous two months.
5. Patients allergic or sensitive to any medication present in the administered gel.
6. Patients with chronic diseases such as Diabetes mellitus, arthritis, thyroid disorder, etc.
7. Female patients who are pregnant or lactating.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare scores of plaque index(GI), gingival index(GI), Probing pocket depth (PPD) , Clinical attachment level (CAL), Modified sulcus bleeding index(mSBI) after administration of 2% curcumin gel, 99% aloevera gel and 1.0% chlorhexidine gel at 4 weeks and 8 weeks in Stage II grade B Periodontitis Patients.  Baseline,4 weeks,8weeks 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   27/01/2026 
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="15" 
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  

       I.   Background: Periodontitis is a prevalent chronic inflammatory disease primarily caused by pathogenic bacteria residing in the subgingival area. Mechanical debridement, such as scaling and root planing (SRP), is the standard treatment; however, it may not be sufficient for sites with deep periodontal pockets. To enhance therapeutic outcomes, adjunctive local drug delivery (LDD) systems have been explored. Traditional antimicrobial agents like chlorhexidine have limitations, including potential side effects and bacterial resistance. Consequently, there is growing interest in alternative agents such as curcumin and aloe vera, which are natural, cost-effective, and have demonstrated anti-inflammatory and antimicrobial properties.

PURPOSE : The primary objective of this single-blind, randomized controlled clinical trial is to compare the clinical efficacy of three LDD agents—2% curcumin gel, 99% aloe vera extract gel, and 1.0% chlorhexidine gel—as adjuncts to SRP in patients with Stage II Grade B periodontitis. The study aims to assess improvements in clinical parameters such as probing pocket depth, clinical attachment level, plaque index, gingival index, and modified sulcus bleeding index. By evaluating these agents, the trial seeks to identify effective, safer, and more accessible alternatives to traditional antimicrobial therapies in periodontal treatment.





 
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