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CTRI Number  CTRI/2023/10/059242 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare tablet and paste form of turmeric to treat gum infection. 
Scientific Title of Study   Comparative evaluation of different formulations of nano-curcumin for the treatment of gingivitis: A 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 Ananya Prabhu 
Designation  Postgraduate 
Affiliation  Manipal Academy of Higher Education  
Address  Room no. 8, Department of Public Health Dentistry Manipal College of Dental Sciences Manipal Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9606679160  
Fax    
Email  ananyaprabhu97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Singhal 
Designation  Associate Professor  
Affiliation  Manipal Academy of Higher Education 
Address  Room no. 8, Department of Public Health Dentistry Manipal College of Dental Sciences Manipal Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9379060983  
Fax    
Email  dk.singhal@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Singhal 
Designation  Associate Professor  
Affiliation  Manipal Academy of Higher Education 
Address  Room no. 8, Department of Public Health Dentistry Manipal College of Dental Sciences Manipal Karnataka 576104


KARNATAKA
576104
India 
Phone  9379060983  
Fax    
Email  dk.singhal@manipal.edu  
 
Source of Monetary or Material Support  
T M A Pai Hospital, old court road, Udupi  
 
Primary Sponsor  
Name  Dr Ananya Prabhu 
Address  Room no 8, Department of Public Health Dentistry Manipal College of Dental Sciences Manipal Karnataka 576104 
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 Deepak Singhal   T.M.A Pai Hospital   Room no. 8, Dental Department, T.M.A Pai Hospital, Udupi
Udupi
KARNATAKA 		 09379060983

dk.singhal@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nanocurcumin 30 mg capsule- SNEC30  Oral Nano-curcumin 30 mg capsule which is available in the market is used in this trial. (SNEC 30) Patients recruited will consume the capsule once per day after breakfast; for 14 days, Oral Nano-curcumin 30 mg OD for 14 days.  
Intervention  Nanocurcumin gel purchased SNEC-G oral gel   Nanocurcumin gel- SNEC-G oral gel. A pea size gel needs to massage on the gums once a day at night for 14 days.  
Comparator Agent  Oral Prophylaxis   Ultrasonic scaling at baseline by a dentist.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with signs of generalized plaque-induced gingivitis.
2. Patient having at least 20 teeth
 
 
ExclusionCriteria 
Details  1. Patients with some systemic disease;
2. Patients undergoing treatment for periodontal disease;
3. Individuals who have used broad-spectrum antibiotics within the last 3 months.;
4. Individuals who have used an antimicrobial mouth rinse within the last two weeks.;
5. Pregnant women;
6. Patients who are allergic to turmeric;
7. Patients with a history of gallstone and/or biliary obstruction
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque index (PI), modified gingival index (MGI),   Baseline, Day 7 and Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
papillary bleeding index (PBI)  Baseline, Day 7 and Day 14 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   02/11/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   The study is conducted among people who have chronic gingivitis( gum infection) due to plaque formation. This is a randomized multi-arm clinical trial that has three groups. Group 1: Gold standard/standard procedure- Ultrasonic scaling, Group 2: 30mg Nanocurcumin Capsule and Group 3: Nanocurcumin gel. Nanocurcumin are used in the treatment of gingivitis. This study is to compare the effectiveness of nano curcumin capsule versus the gel.  
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