| CTRI Number |
CTRI/2025/03/082614 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Effect of Applying Coconut Oil and Chlorhexidine Mouth Wash in Improving Oral Hygiene of Patients Undergoing Orthodontic Treatment |
|
Scientific Title of Study
|
Comparative Evaluation of the Effectiveness of Coconut Oil Pulling and Chlorhexidine Mouth Rinse in Patients Undergoing Orthodontic Treatment-Randomized Control 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 Megha Dilip |
| Designation |
First year Postgraduate Student |
| Affiliation |
Kannur Dental College,Anjarakkandy |
| Address |
Department of Orthodontics and Dentofacial Orthopedics,
Room No : 8
Kannur Dental College Anjarakkandy Integrated Campus, Kannur, Kerala, India
Kannur
KERALA
670612
India |
| Phone |
9074891910 |
| Fax |
|
| Email |
meghadilip97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hashim Ali P |
| Designation |
Professor and Head |
| Affiliation |
Kannur Dental College, Anjarakkandy |
| Address |
Department of Orthodontics and Dentofacial Orthopedics,
Room No : 8
Kannur Dental College Anjarakkandy Integrated Campus, Kannur, Kerala, India
Kannur
KERALA
670612
India |
| Phone |
9447090616 |
| Fax |
|
| Email |
drhashimmds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Dilip |
| Designation |
First year Postgraduate student |
| Affiliation |
Kannur Dental College,Anjarakkandy |
| Address |
Department of Orthodontics and Dentofacial Orthopedics,
Room No : 8
Kannur Dental College Anjarakkandy integrated campus, Kannur state Kerala district India
Kannur
KERALA
670612
India |
| Phone |
9074891910 |
| Fax |
|
| Email |
meghadilip97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kannur Dental College, Anjarakandy Integrated Campus,Kannur,kerala,
India 670612 |
|
|
Primary Sponsor
|
| Name |
Dr Megha Dilip |
| Address |
Department of Orthodontics and Dentofacial Orthopedics,
Room No : 8
Kannur Dental College Anjarakkandy Integrated Campus, Kannur, Kerala, India,670612 |
| 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 Megha Dilip |
Kannur Dental College, Anjarakandy |
Department of Orthodontics and Dentofacial Orthopedics,
Room No : 8
Kannur Dental College Anjarakkandy Integrated Campus, Kannur, Kerala, India
Kannur
KERALA |
9074891910
meghadilip97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kannur Dental Colleg |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine Mouth Wash (0.2%) |
Swish and spit 5ml of Chlorhexidine mouth for 5 minutes once daily.
Follow up in every 2 week for 2months. |
| Intervention |
Coconut oil pulling |
Swish and spit 5ml of coconut oil for 5 minutes once daily.
Follow up in every 2 weeks for 2months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing fixed orthodontic treatment after one month of the starting of the
orthodontic treatment
Age between 20-30 years
Patients doing tooth brushing two times a day |
|
| ExclusionCriteria |
| Details |
Patients with presence of periodontal pathology, and having systemic diseases
Patient taking any antibiotics, anti-inflammatory drugs, mouth washes in past one
months
Pregnancy & Lactation
Patients intolerant to coconut oil |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque Index and Gingival Index Scores |
1 st day (Before intervention) ,15th ,29 th ,43 nd ,57 th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Minimum one unit change in the plaque index and gingival index score |
1 st day (Before intervention) ,15th ,29 th ,43 nd ,57 th days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a Randomized control trial to evaluate effectiveness of coconut oil pulling and chlorhexidine in patients in patients undergoing orthodontic treatment. This is a hospital-based study conducting in the Department of orthodontics and dentofacial Orthopedics, Kannur Dental college, Kerala. Patients in the age group of 20 to 30 years and patients undergoing fixed orthodontic treatment after one month of the starting of the orthodontic treatment includes inclusion criteria. Exclusion criteria include patients with presence of periodontal pathology, and having systemic diseases patient taking any antibiotics, anti-inflammatory drugs, mouth washes in past one months pregnancy and lactation, patients intolerant to coconut oil. All participants will be explained about the study and informed consent will be obtained. Group 1 with 50 participants will be give Chlorhexidine mouth wash (0.2%) and asked to swish and spit for 5 minutes once daily and group 2 with 50 participants will be given Coconut oil and asked to swish and spit for 5 minutes once daily for two months. Duration of study is 1 year. Sample were taken from patients at 1 st ,15 th ,29 th ,43 rd ,57th day and outcome is measured by taking Plaque Index and Gingival Index. |