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CTRI Number  CTRI/2024/04/065946 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of oil pulling as an adjuct therapy on plaque induced gingivitis 
Scientific Title of Study   Efficacy of Irimedadi oil and Virgin Coconut oil pulling on plaque induced gingivitis: a randomized 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  INAMDAR ISHA ABHAY 
Designation  Postgraduate student 
Affiliation  Dr. DY Patil Dental College and Hospital, Pimpri 
Address  Dr. DY Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  7588331185  
Fax    
Email  ishaainamdar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ANMOL MATHUR 
Designation  Professor Head of the Department 
Affiliation  Dr. DY Patil Dental College and Hospital, Pimpri 
Address  Dr. D.Y. Patil Dental College & Hospital, Sant Tukaramnagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9899963523  
Fax    
Email  dranmolmathur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ANMOL MATHUR 
Designation  Professor Head of the Department 
Affiliation  Dr. DY Patil Dental College and Hospital, Pimpri 
Address  Dr. D.Y. Patil Dental College & Hospital, Sant Tukaramnagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9899963523  
Fax    
Email  dranmolmathur@gmail.com  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, Dr D.Y. Patil Dental College & Hospital 
 
Primary Sponsor  
Name  Dr DY PATIL DENTAL COLLEGE AND HOSPITAL PUNE 
Address  Dr D.Y. Patil Dental College & Hospital Sant Tukaram Nagar, Pimpri, Pune 411018 
Type of Sponsor  Research institution and hospital 
 
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 Isha Inamdar  Department number 5, Public Health DentistryDr D.Y. Patil Dental College & Hospital  Dr D.Y. Patil Dental College & Hospital, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA 
7588331185

ishaainamdar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee. Dr. D.Y. Patil Vidyapeeth, Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Irimedadi Oil  Group A (test) will be given 100ml Irimedadi oil. They will be asked to perform oil pulling once daily after tooth brushing using modified BASS technique for 28 days. 
Comparator Agent  Virgin Coconut Oil  Group B (control) will be given 100ml virgin coconut oil. They will be asked to perform oil pulling once daily after tooth brushing using modified BASS technique for 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with minimum 20 teeth present.
2. Patients who have not received any periodontal therapy in past 6 months.
3. Patients with GI score ≥ 1
4. Patients with presence of bleeding on probing & probing depth ≤ 3mm
5. Patients who brush at least once daily.
6. Patients willing to participate.
 
 
ExclusionCriteria 
Details  1. Patients practicing oil pulling with other oils.
2. Patients on any antibiotic therapy.
3. Pregnant or lactating mothers.
4. Patients with tobacco habits.
5. Patients with periodontal pockets ≥ 4mm.
6. Patients with known history of allergy towards herbal products.
7. Patients who are mouth breathers.
8. Patients undergoing any orthodontic therapy
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The patients’ PI, GI and gingival bleeding scores will be recorded.
2.Plaque samples will be collected & CFUs will be calculated.
3.Scaling and polishing will be done, to bring the plaque score down to 0
 
Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Follow up will be done after 28 days, PI, GI and gingival bleeding scores will be recorded.
2.Plaque samples will be collected & CFUs will be calculated. 
Post intervention after 28 days. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/05/2024 
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)   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  

NEED FOR STUDY:
Optimal oral hygiene is achieved by maintenance of a healthy periodontium along with caries free teeth. Presence of periodontal diseases such as gingivitis and periodontitis can be attributed to numerous factors, out of which the most common is plaque accumulation. This optimal oral health can be achieved by two methods, A) mechanical methods such as scaling, root planning, tooth brushing, flossing and tongue cleaning, and B) chemical methods such as use of mouthwashes and therapeutic dentifrices. [2,4] Along with these established dental aids, more research is done to incorporate other products, for example, a study on rats was conducted by Shern et al in which 0.1% stannous fluoride rinses for decreased plaque accumulation was demonstrated. These new improvements along with the currently used mouthwash considered as gold standard i.e., 2% Chlorhexidine have certain unpleasant side effects such as unpleasant taste, and their chemical nature could cause tooth staining. [5]
Ayurveda, the ancient medical system developed in India is a reservoir of natural, palnt based remedies for all diseases and ailments of the human body. Herbal products prove to be useful as they work without alcohol incorporation, and thus produce less side effects. [5] Ayurveda provides good alternatives for dental and oral health management, which include procedures such as kavala, gandusha, dantadhavana, and jivha lekhana. [2] Out of these methods, kavala and gandusha styles are used under oil pulling, a method of swishing oil in the mouth, which is in use for 5000 years to maintaining good oral hygiene. [1]
Oil pulling claims to be useful in decreasing the levels of toxins and bacterial load from the mucous membrane and the blood stream. However more scientific evidence which supports this claim is lacking. [6] Recent studies have reported decrease in the levels of Streptococcus mutans in plaque after oil pulling done with virgin coconut oil. [1] According to a systematic review conducted by Woolley et al more properly designed randomized controlled trials among different strata of the population are needed to assess the impact of coconut oil pulling on oral health. [6]
 Irimedadi oil is made of Yashti, Trijatha, Manjishta, Gayatri, Lodhra, Katphala, Kshirivrikshatwak, Irimeda twak, Musta, Agaru, Shvetachandana, Rakta chandana, Karpoora, Jati, Takkola, Mamsi, Dhataki, Gairika, Mrinala, Mishi, Vaidedi, Padmakesara, Kumkuma, Laksha, Samanga, Manjishta, Brihati, Bilvapatra, Suradruma, Shaileya, Sarala, Sprikka, Palasha, Rajani, Daruharidra, Priyangu, Tejani, Pradhakaleya, Pushkara, Jaya, Vyaghri, Madana, Tila taila. [2] In Ayurveda, dental indications for the use of this oil are stomatitis, glossitis, apthous ulcers, dental caries, pyorrhea, gingivitis, stains removal and hyperemia of gums. But the effect of Irimedadi taila on plaque reduction and plaque induced gingivitis has not been explored. [2]
Thus, a comparison between these two oils used for oil pulling, with the purpose of determining their efficacy on the improvement of the oral health and decreasing the oral plaque inducing bacterial load as an alternative oral hygiene aid is the purpose of this study.
 
AIM: To assess the efficacy of Irimedadi oil & virgin coconut oil pulling as an adjunct therapy on plaque induced gingivitis.
 
OBJECTIVES:
1.     To evaluate & compare the baseline and post intervention microbiological effect along with PI, GI and gingival bleeding scores among patients assigned Irimedadi oil.
2.     To evaluate & compare the baseline and post intervention microbiological effect along with PI, GI and gingival bleeding scores among patients assigned Virgin Coconut oil.
3.     To compare the microbiological effect along with PI, GI and gingival bleeding scores among the two interventions.
 
METHODS:
Invitation
Patients from regular OPD will be invited to join the study.
ENROLLMENT
Patients selected as per inclusion criteria.
BASELINE DATA COLLECTION
1.     The patients’ PI, GI and gingival bleeding scores will be recorded.
2.     Plaque samples will be collected.
3.     Scaling and polishing will be done, to bring the plaque score down to 0.
RANDOMISATION
Block randomization sampling technique is used to form the test & control group.
INTERVENTION
Group A (test) will be given 100ml Irimedadi oil and Group B (control) will be given 100ml virgin coconut oil. They will be asked to perform oil pulling once daily after tooth brushing using modified BASS technique for 28 days
 
FOLLOW UP
Participants will be called in after every 10 days to assess the use of oil, and to provide them with more.
2nd DATA COLLECTION
1.     Follow up will be done after 28 days, PI, GI and gingival bleeding scores will be recorded.
2.     Plaque samples will be collected.
MICROBIOLOGICAL TESTING
1.     Collected plaque samples will be forwarded for microbiological lab testing for CFU as & when collected during pre & post intervention.
 


 
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