| CTRI Number |
CTRI/2024/11/076976 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on Gum Health and Safety in Braces Patients Using Chlorine Dioxide Mouthwash |
|
Scientific Title of Study
|
Assessment of periodontal status and biocompatibility in orthodontic patients with and without adjunct chlorine dioxide mouthwash– 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 |
S Lochini |
| Designation |
PG Student |
| Affiliation |
SRM Kattankulathur dental college and Hospital |
| Address |
Room No 106
Department of Periodontology
SRM Kattankulathur dental college and Hospital
SRM Nagar Potheri
Chengalpet
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7339319355 |
| Fax |
|
| Email |
ls7751@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P L Ravishankar |
| Designation |
Head of department |
| Affiliation |
SRM Kattankulathur dental college and Hospital |
| Address |
Room No 106
Department of Periodontology
SRM Kattankulathur dental college and Hospital
SRM Nagar Potheri
Chengalpet
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
9848113248 |
| Fax |
|
| Email |
ravishak@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P L Ravishankar |
| Designation |
Head of department |
| Affiliation |
SRM Kattankulathur dental college and Hospital |
| Address |
Room No 106
Department of Periodontology
SRM Kattankulathur dental college and Hospital
SRM Nagar Potheri
Chengalpet
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
9848113248 |
| Fax |
|
| Email |
ravishak@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr S Lochini
Department of periodontology
SRM Kattankulathur dental college and hospital
SRM nagar potheri
Chengalpet 603 203
Tamilnadu
|
| SRM kattankulathur dental college and hospital |
|
|
Primary Sponsor
|
| Name |
S LOCHINI |
| Address |
Room No 106
Department of Periodontology
SRM Kattankulathur dental college and Hospital
SRM Nagar Potheri
Chengalpet |
| 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 S LOCHINI |
SRM Kattankulathur dental college and Hospital |
4th floor
Room No 106
Department of Periodontology
SRM Kattankulathur dental college and Hospital
SRM Nagar Potheri
Chengalpet
Kancheepuram
TAMIL NADU |
7339319355
ls7751@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college hospital and research center |
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 |
| Intervention |
CHLORINE DIOXIDE |
Subjects with fixed orthodontic therapy will be given customized interdental brushes for brushing and chlorine dioxide mouthwash will be given 2 times daily for a period of 2 weeks from start of orthodontic treatment. |
| Comparator Agent |
Interdental brushes |
Subjects with fixed orthodontic therapy will be given customized interdental brushes . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Clinically healthy with no systemic illness
Subjects with no previous history of orthodontic treatment
|
|
| ExclusionCriteria |
| Details |
Subjects with syndromes and debilitating diseases
Oral mucosal lesions
Smokers and tobacco chewers
Subjects with prosthesis or restorations
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PLAQUE INDEX
GINGIVAL BLEEDING INDEX
PROBING POCKET DEPTH
CLINICAL ATTACHMENT LEVEL |
BASELINE
1 MONTH
3RD MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MICRONUCLEUS TEST |
BASELINE
1 MONTH
3RD MONTH |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/11/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Oral prophylaxis will be performed in the department of periodontics before starting the orthodontic treatment Full mouth periodontal status will be recorded and swab will be collected in the buccal mucosa with soft bristles and placed inside a buffer solution container which act a transport medium for micronucleus examination. CONTROL GROUP patients will be instructed to use interdental brushes TEST GROUP Patients will be instructed to use interdental brushes and adjunct chlorine dioxide mouthwash for 2 weeks twice a day for 1minute · Periodontal examination and buccal swab will be collected from both groups at baseline 1 month and 3rd month for micronucleus test |