| CTRI Number |
CTRI/2022/07/044234 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate which mouthwash is more efficacious in reducing bacteria after gum surgery |
|
Scientific Title of Study
|
Comparative evaluation of antibacterial efficacy of Cetylpyridinium chloride and Chlorhexidine gluconate mouthwashes after periodontal surgery- A randomized clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mugdha Mangaonkar |
| Designation |
PG student |
| Affiliation |
MGM dental college and hospital Kamothe |
| Address |
Department of Periodontics 7th floorroom no 9 sectore 18 MGM dental college and hospital Navi mumbai Raigarh Maharashtra
Mumbai
MAHARASHTRA
400024
India |
| Phone |
9769606945 |
| Fax |
|
| Email |
mugdhamangaonkar95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashvini Padhye |
| Designation |
Guide and head of department |
| Affiliation |
MGM dental college and hospital Kamothe |
| Address |
Department of Periodontics 7th floor room no 9 sector 18 kamothe navi mumbai raigarh
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9820138480 |
| Fax |
|
| Email |
drashvini16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mugdha Mangaonkar |
| Designation |
PG student |
| Affiliation |
MGM dental college and hospital Kamothe |
| Address |
Department of Periodontics 7th floor room no 9 sector 18 MGM dental college navi mumbai raigarh
Mumbai
MAHARASHTRA
400024
India |
| Phone |
9769606945 |
| Fax |
|
| Email |
mugdhamangaonkar95@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM dental college and hospital, 7th floor room no. 9, kamothe - self funded |
|
|
Primary Sponsor
|
| Name |
Dr Mugdha Mangaonkar |
| Address |
10 prayatna shivsrushti kurla east mumabai 400024 |
| Type of Sponsor |
Other [self-funded] |
|
|
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 Mugdha Mangaonkar |
MGM dental college |
departmetn of periodontics, 7th floor, MGM dental college, kamothe, navi mumbai
Mumbai
MAHARASHTRA |
9769606945
mugdhamangaonkar95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM dental college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.2% Chlorhexidine gluconate mouthwash |
0.2% chlorhexidine gluconate mouthwash Patient will be advised to use it twice daily 10 ml by oral route for 1 minute to rinse and then spit. Half hour after brushing. |
| Comparator Agent |
0.2% Chlorhexidine gluconate mouthwashe |
0.2% chlorhexidine gluconate mouthwash as it is gold standard. Patient will be advised to use it twice daily 10 ml by oral route for 1 minute to rinse and then spit. Half hour after brushing. |
| Intervention |
Cetylpyridinium chloride mouthwash |
Cetylpyridinium chloride mouthwash. Patient will be advised to use it twice daily 10 ml by oral route for 1 minute to rinse and then spit. Half hour after brushing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing periodontal surgery.
patients willing to participate |
|
| ExclusionCriteria |
| Details |
A) Patients with any systemic diseases.
B) Pregnant and lactating women.
C) Smokers or any other deleterious habits
D) Immune and mental disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the antibacterial efficacy of the cetylpyridinium chloride mouthwash and chlorhexidine gluconate mouthwash after the periodontal surgery after checking colony forming units |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses better mouthwash for patient usage after periodontal surgery by checking colony forming units |
One day |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2022 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Following periodontal surgery patients will be rabdomized in 2 groups to comparatively evaluate the antibacterial efficacy of cetylpyridinium chloride and chlorhexidine gluconate mouthwashes on basis of colony forming units after collecting the sutures from the patient. The rationale of this study will be to determine which mouthwash is more efficacious in reducing bacterial growth after periodontal surgery |