| CTRI Number |
CTRI/2022/11/047230 [Registered on: 11/11/2022] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to compare the effects of cetyl pyridinium mouth wash, toothpaste and chlorhexidine mouth wash, toothpaste in patients with irregularly placed teeth. |
|
Scientific Title of Study
|
Comparative evaluation of antibacterial efficacy, Clinical effects and Patient perception on usage of Cetyl pyridinium chloride based products with regular mouthwash and dentifrice in Orthodontic patients- A Randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhogi Akhil Kumar |
| Designation |
Post Graduation Student |
| Affiliation |
Vishnu Dental College |
| Address |
Room Number 6,
Department of Orthodontics And Dentofacial Orthopaedics,
Vishnu Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9666555456 |
| Fax |
08816-250894 |
| Email |
akhilkumar.bhogi@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C V Padma Priya |
| Designation |
Professor And Head |
| Affiliation |
Vishnu Dental College |
| Address |
Room Number 6,
Department of Orthodontics And Dentofacial Orthopaedics,
Vishnu Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9440712238 |
| Fax |
08816-250894 |
| Email |
padmapriyacv@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Bhupathi |
| Designation |
Assistant Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room Number 6,
Department of Orthodontics And Dentofacial Orthopaedics,
Vishnu Dental College,
Vishnupur,
Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9885923485 |
| Fax |
08816-250894 |
| Email |
arunbhupathi.p@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram-534202, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Bhogi Akhil Kumar |
| Address |
Room Number 6,
Department Of Orthodontics And Dentofacial Orthopaedics,
Vishnu Dental College,
Vishnupur,
Bhimavaram-534202,
West Godavari,
Andhra Pradesh. |
| 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 |
| Bhogi Akhil Kumar |
Vishnu Dental College |
Room Number 6,
Department Of Orthodontics And Dentofacial Orthopaedics,
Vishnu Dental College,
Vishnupur,
Bhimavaram-534202,
West Godavari,
Andhra Pradesh.
West Godavari
ANDHRA PRADESH |
9666555456
08816-250894
akhilkumar.bhogi@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K006||Disturbances in tooth eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
colgate periogard mouthwash |
This mouthwash contains Chlorhexidine as active ingredient is given to the patient to rinse 15ml twice daily for 15-30sec for 1 month |
| Intervention |
Colgate Total mouthwash |
This mouthwash contains Cetyl pyridinium chloride as active ingredient is given to the patient to rinse 15ml twice daily for 15-30sec for 1month |
| Comparator Agent |
elgydinium tooth paste |
This tooth paste contains Chlorhexidine as a active ingredient is given to the patient to brush twice daily at quantity of size of pea for 2-3 minutes for 1month. |
| Intervention |
Halita tooth paste |
This tooth paste contains Cetyl pyridinium chloride as a active ingredient is given to the patient to brush twice daily at quantity of size of pea for about 2-3 minutes for 1 month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Age range of 18-25 years.
2.Willingness to participate in the study
3.Mild gingivitis
4.Patients with Pre adjusted edgewise stainless steel brackets |
|
| ExclusionCriteria |
| Details |
. Antibiotic therapy in last month
. Medical problems
. Pregnancy and lactation
. Smoking
. Moderate or severe gingivitis/ periodontitis
. History of hypersensitivity to mouth rinses
. Using any mouth rinse in last month |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. anti bacterial efficacy of mouthwash and dentifrice,
2. Periodontal index
3. Gingival index |
1. anti bacterial efficacy of mouthwash and dentifrice T0-15thday, T1-30th day, T2- 45thday
2. Periodontal index T0-15thday, T1-30th day, T2- 45thday
3. Gingival index T0-15thday, T1-30th day, T2- 45thday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patients perception by a questionnaire |
T1-30th day, T2-45th day |
|
|
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)
|
16/11/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the academic research study is to compare and assess anti-bacterial efficacy, clinical effects and patient perception using CPC based products with regular mouth wash and dentifrice. 48 Patients who meets inclusion criteria will be included in the study. After the oral prophylaxis, brackets placement followed by arch wire in the baseline will be done. Proper brushing technique is explained to the patients. Based on lottery method patients will be randomly divided into experimental and control groups. Patient will be recalled after 15days. Patients will be prescribed with specific mouthwash/dentifrice and are advised to use them for 1month. Frequency, duration, techniques for use are explained. Clinical parameters such as gingival index and plaque index will be noted for clinical evaluation, Plaque sample will be collected for bacterial evaluation. Patient will be recalled on 30thday and 45th day where gingival index, plaque index will be recorded, plaque sample will be taken for bacterial count, a questionnaire form will be given to the patient to evaluate his perception on usage of these products. |