| 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" |
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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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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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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