| CTRI Number |
CTRI/2021/01/030264 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
16/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISION BETWEEN THREE DIFFERENT MOUTHRINSES TO REDUCE GINGIVAL INFLAMMATION IN ORTHODONTIC PATIENTS |
|
Scientific Title of Study
|
EVALUATION OF GINGIVAL STATUS DURING DECROWDING IN ORTHODONTIC PATIENTS BY THREE DIFFERENT MOUTHRINSES - ANTI-OXIDANT, ESSENTIAL OIL AND CHLORHEXIDINE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHARGHAV RAYALA |
| Designation |
Post-Graduate |
| Affiliation |
Narayana Dental College |
| Address |
Department of Orthodontics, Narayana Dental College, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9885673456 |
| Fax |
|
| Email |
rayalabharghav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandava Prasad |
| Designation |
Professor & Head |
| Affiliation |
Narayana Dental College |
| Address |
Department of Orthodontics, Room No: 6, Narayana Dental College, Chinthareddypalem, nellore
Department of Orthodontics, Room No: 6, Narayana Dental College, Chinthareddypalem, nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440976666 |
| Fax |
|
| Email |
mandavabruno9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Gowri Sankar |
| Designation |
Professor |
| Affiliation |
Narayana Dental College |
| Address |
Department of Orthodontics, Room No: 6, Narayana Dental College, Chinthareddypalem, nellore
Department of Orthodontics, Room No: 6, Narayana Dental College, Chinthareddypalem, nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440012443 |
| Fax |
|
| Email |
drgowrisankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College, Nellore |
|
|
Primary Sponsor
|
| Name |
Bharghav Rayala |
| Address |
Department of Orthodontics, Narayana Dental College, Chinthareddypalem, Nellore |
| 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 |
| Bharghav Rayala |
Department of Orthodontics |
Department of Orthodontics, Narayana Dental College, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH |
9885673456
rayalabharghav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Narayana Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti Oxidant Mouthrinse |
Phloretin and Ferulic acid containing mouthrinse is given in order to reduce gingival inflammation |
| Comparator Agent |
Chlorhexidine Mouthrinse |
Chlorhexidine containing mouthrinse is given in order to reduce gingival inflammation |
| Intervention |
Essential Oil Mouthrinse |
Thymol and Eucalyptol containing mouthrinse is given in order to reduce gingival inflammation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with good physical and mental health.
2.Patients with fixed orthodontic therapy, have bonded brackets in the mandibular arch from the first premolar to first premolar or from the second premolar to the second premolar if first premolars had been extracted.
3.Patients with minimum crowding of Little’s index of less than 4-5mm.
4.Patients exhibiting a minimum of 30% bleeding on probing at qualifying sites at the initial appointment
|
|
| ExclusionCriteria |
| Details |
1.Syndromes or systemic diseases that could have contributed to the inflammatory processes of gingival (such as lichen planus, systemic lupus erythematosus, and benign mucous membrane pemphigoid diseases.
2.Patients on drug therapy that may affect gingiva.
3.Pregnancy.
4.Active caries.
5.Periodontally compromised teeth.
|
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival Index by Loe and Silness |
3 time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Orthodontic Plaque Index |
0 days, 28 days, 56 days, 84 days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2021 |
| Date of Study Completion (India) |
01/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
- |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is done to evaluate the differences among the efficacy of three different mouthrinses in reducing the gingivitis that is caused by initation of orthodontic treatment |