| CTRI Number |
CTRI/2024/02/062508 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Testing efficacy of mouthwash containing antioxidant and essential oil in preventing gum problems in people with braces. |
|
Scientific Title of Study
|
Evaluating the effects of antioxidant and essential oil containing mouthwash on prevention of gingival diseases in patients during fixed orthodontic treatment - A double-blinded 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 Yatishkumar Joshi |
| Designation |
Vice-principle and professor |
| Affiliation |
Maharashtra Institute of Dental Science and Research Centre Latur |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, MIDSR Dental College, Latur.
Maharashtra
Latur
MAHARASHTRA
413512
India |
| Phone |
9860636690 |
| Fax |
|
| Email |
orthoyatishjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathilekshmi Nair |
| Designation |
Post graduate |
| Affiliation |
Maharashtra Institute of Dental Science and Research Centre Latur |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, MIDSR Dental College, Latur.
Maharashtra
Latur
MAHARASHTRA
413512
India |
| Phone |
9503260886 |
| Fax |
|
| Email |
nairswathi886@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathilekshmi Nair |
| Designation |
Post graduate |
| Affiliation |
Maharashtra Institute of Dental Science and Research Centre Latur |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, MIDSR Dental College, Latur.
Maharashtra
Latur
MAHARASHTRA
413512
India |
| Phone |
9503260886 |
| Fax |
|
| Email |
nairswathi886@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-supported by (Dr. Swathilekshmi Nair and Dr. Yatishkumar Joshi). Monetary support from Maharashtra Institute of Dental Sciences and Research Dental College Latur. |
|
|
Primary Sponsor
|
| Name |
MIDSR Dental College Latur |
| Address |
Mharashtra Institute of Dental Sciences and Research Dental College, Ambajogai Road, Latur |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 |
| Swathilekshmi Nair |
MIDSR Dental College Latur |
Department of Orthodontics and Dentofacial Orthopaedics, MIDSR Dental College, Latur
Latur
MAHARASHTRA |
9503260886
nairswathi886@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MIDSR Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To check gingival and plaque index in patients undergoing fixed orthodontic treatment |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo mouthwash |
Placeo mouthwash contains 1 litre of distilled water and 0.3ml of methylene blue in a concentration of 0.0003mg/ml |
| Intervention |
Purexa mouthwash |
Purexa Mouthwash contains:
Antioxidant - Coenzyme Q10
and Hyaluronic acid
Essential oils- tea tree oil,aloe vera and myrrh
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 12 to 28 years.
2.Patient with erupted permanent teeth (incisors, canines, premolars and at least first molar).
3.Patient with good general health.
4.Patient undergoing fixed orthodontic treatment with brackets on their teeth.
5.Patients voluntarily involving in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient with syndromes or systemic diseases
2.Patients in pregnancy.
3.Patients with active caries.
4.Patients with multiple prosthesis.
5.Patients with Periodontally compromised teeth.
6.Patients with allergy to any ingredients in the mouthrinse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure gingival index and plaque index on patients using the antioxidant and essential oil mouthwash during fixed orthodontic treatment for 90 days. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the primary outcomes of gingival index and plaque index on using the antioxidant and essential oil mouthwash with the placebo-control group during fixed orthodontic treatment. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/02/2024 |
| Date of Study Completion (India) |
09/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Many studies have shown that fixed orthodontic appliances
create new locations for plaque retention, thereby increase the risk of
gingival inflammation.Gingivitis is among the most common pathologies
affecting the population, with a reported prevalence of over 50%. Mechanical methods of oral hygiene, brushing and
flossing are considered by clinicians as the gold standard methods of plaque
control. However, despite this emphasis on mechanical methods of plaque
control, the prevalence of gingival inflammation is high. For this reason other oral hygiene agents such as
dentifrices, gels, and mouthwashes with anti-plaque and anti-gingivitis
properties can add to the effects of mechanical plaque control may have
clinical value.Chlorhexidine containing mouth rinses are accepted as the gold standard.
However, these rinses have side effects like extrinsic staining which limits
their usage.Due to these inadvertent effects, mouthrinses
with essential oils and antioxidants have gained importance. This present study
aims to evaluate effects of antioxidant and essential oil containing mouth wash
on prevention of gingival diseases in patients undergoing orthodontic
treatment.
|