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CTRI Number  CTRI/2022/10/046385 [Registered on: 12/10/2022] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical and laboratory examination of dental plaque in hospitalised children treated topically with olive oil, olive oil with white turmeric, and olive oil with neem 
Scientific Title of Study   Clinical and Microbiological Evaluation of Dental Plaque on topical application of Olive oil, Olive oil with 35% Curcuma zedoaria and Olive oil with 30% Azadirachta indica in hospitalized children: A Randomised Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Simron Baishya 
Designation  Post graduate student 
Affiliation  K M Shah Dental College 
Address  Dept 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Dept 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT
391760
India 
Phone  9707724987  
Fax    
Email  simranb46@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anshula Deshpande 
Designation  Professor 
Affiliation  K M Shah Dental College 
Address  Dept 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Dept 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT
391760
India 
Phone  7600916400  
Fax    
Email  dranshula@gmail.com  
 
Details of Contact Person
Public Query  
Name  Simron Baishya 
Designation  Post graduate student 
Affiliation  K M Shah Dental College 
Address  Dept 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Dept 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT
391760
India 
Phone  9707724987  
Fax    
Email  simranb46@gmail.com  
 
Source of Monetary or Material Support  
KMSDCH, Sumandeep Vidyapeeth University 
 
Primary Sponsor  
Name  Simron Baishya 
Address  KMSDCH, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Anshula Deshpande  KMSDCH, Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Simron Baishya  Dhiraj hospital, Smt. B K Shah Medical Institute & Research Centre  Sumandeep Vidyapeeth University, Waghodia Road, Piparia, Taluk Waghodia, Vadodara, Gujarat 391760
Vadodara
GUJARAT 		 9707724987

simranb46@gmail.com 
Simron Baishya  Sumandeep Hospital  Kothi Rd, opp. Govt. Press, Anandpura, Vadodara, Gujarat 390001
Vadodara
GUJARAT 		 9707724987

simranb46@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Azadirachta indica with olive oil  Azadirachta indica with olive oil (30:70 v/v) 2ml twice daily for 3 days 
Intervention  Curcuma zedoaria with olive oil  Curcuma zedoaria with olive oil (35:65 v/v) 2ml twice daily for 3 days 
Intervention  Extra virgin olive oil  Extra virgin olive oil(100) 2ml twice daily for 3 days 
Comparator Agent  Normal saline  Sodium chloride (0.9%) 2ml twice daily for 3 days 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children from 3-14 years of age.
2. Children hospitalized for a minimum period of 4days
3. Non ambulatory hospitalized children who cannot brush/expectorate
 
 
ExclusionCriteria 
Details  1. Children who did not give assent
2. Children whose Parents did not give consent
3. Children using oxygen mask
4. Children in ventilator
5. Children in ICU - high risk
6. Children having allergy to Azadirachta or Curcuma
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The synergistic impact of two herbal oils can reduce plaque, bacterial and fungal growth.
The microbial load (Streptococcus mutans, Lactobacillus and Candida albicans) and accumulation of dental plaque would be reduced. 		 Clinical and microbiological response after 24, 48 and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
The palatibilty of the product by the patient by Likert scale  Baseline, after 24, 48 and 72hours 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/10/2022 
Date of Study Completion (India) 30/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a triple-blinded, randomized clinical study, clinically and microbiologically evaluating dental plaque on topical application of olive oil, olive oil with 35% Curcuma zedoaria and olive oil with 30% Azadirachta indica in hospitalized children. The study would include clinical evaluation of dental plaque in hospitalized children by Silness and Loe plaque index and microbiological evaluation of Streptococcus mutans, Lactobacillus and Candida albicans by CFU count after 24hours, 48hours and 72hours of application of oil/saline.

Need of the study: There have been historical benefits of use of fats and studies on oil pulling in prevention of caries. The local application for vulnerable people needs to be studied. Vulnerable people like hospitalized children & children with special healthcare needs, are often unable to maintain good dental hygiene. They could face a challenge to brush & floss. Under such circumstances, direct application of herbal oil as anti-plaque agent on tooth surface can be beneficial in removing the biofilm and thereby controlling plaque formation and fungal infections. Identifying the potential of medicinal plants as phytochemical compounds can lead to cost effective herbal formulations in the field of dentistry.

Null hypothesis: There is no difference in plaque control after the application of the three products: extra virgin olive oil, extra virgin olive oil with 35% Curcuma zedoaria and extra virgin olive oil with 30% Azadirachta indica when compared with normal saline (control group).

 
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