| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
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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.
|