| CTRI Number |
CTRI/2024/02/062491 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Denture Adhesive cream |
|
Scientific Title of Study
|
A Clinical trial to study efficacy of Denture Adhesive Cream in Maxillary Complete Dentures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/272/PCB/2023 Dated 15/12/23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Pankaj Datta |
| Designation |
Dean and Professor |
| Affiliation |
Smile Centre Dental Clinic |
| Address |
Smile Centre Dental Clinic,
LSC Saini Enclave Market, Vikas Marg, Delhi
Department of Prosthodontics, Rehabilitation Division,
Room 1,
Smile Centre, Delhi
East
DELHI
110092
India |
| Phone |
9811274799 |
| Fax |
0 |
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pankaj Datta |
| Designation |
Dean and Professor |
| Affiliation |
Smile Centre Dental Clinic |
| Address |
Smile Centre Dental Clinic,
LSC Saini Enclave Market, Vikas Marg, Delhi
Department of Prosthodontics, Rehabilitation Division,
Room 1,
Smile Centre, Delhi
East
DELHI
110092
India |
| Phone |
9811274799 |
| Fax |
0 |
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pankaj Datta |
| Designation |
Dean and Professor |
| Affiliation |
Smile Centre Dental Clinic |
| Address |
Smile Centre Dental Clinic,
LSC Saini Enclave Market, Vikas Marg, Delhi
Department of Prosthodontics, Rehabilitation Division,
Room 1,
Smile Centre, Delhi
East
DELHI
110092
India |
| Phone |
9811274799 |
| Fax |
0 |
| Email |
pankajdatta97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Dabur India Limited,Plot Number 22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot Number 22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Pankaj Datta |
Smile Centre Dental Clinic |
Department of Prosthodontics, Rehabilitation Division,
Room 1,
Plot 104, Sagar Chambers, LSC Saini Enclave Market, Vikas Marg, Delhi
East
DELHI |
9811274799
pankajdatta97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Inderprastha Dental College and Hospital |
Approved |
| Institute Ethics Committee, Inderprastha Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Edentulous subjects aged between 50- 80 years
(both inclusive) wearing complete maxillary
dentures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Denture Adhesive Cream |
Cellulose gum, Mineral oil, Petroleum, Beeswax, Polymethylvinylether maleic acid Sodium-Calcium salt, Polyethylene Oxide, D & C Red #27 aluminium lake, Tocopheryl acetate. The adhesive will be applied in the denture, 4 strips of 1 cm at the frontal, dorsal, right and left border of hard palate. The duration of application will be for 7 days once daily. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cases with single maxillary complete denture with natural dentition in mandibular arch [complete or partial (anterior teeth present) In cases of partial arch, anterior teeth should be present in mandibular arch
Subjects wearing complete dentures for a minimum period of one year General good health No systemic disease
|
|
| ExclusionCriteria |
| Details |
Subjects wearing complete denture (upper & lower dentures)
Handicapped & medically compromised subjects
Single complete denture cases with duration less than 1 year
Patients not satisfied with their denture in terms of retention, stability or occlusion
Single complete denture cases with missing mandibular anterior teeth. Those not fulfilling inclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximum dislodgement force |
Baseline, 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Retention of Complete maxillary dentures |
Baseline, 1 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
19/02/2024 |
| 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="1"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will be a monocentric, single arm, open label, efficacy study. The duration of treatment will be for a period of 1 week on 30 subjects (both males and females); aged between 50-80 years (both inclusive) and will include a total of 2 visits (Baseline, 1 week). The subjects who satisfy inclusion/exclusion criteria will be enrolled after obtaining informed consent. All the subjects in the study will be monitored for signs of adverse events/side effects during the entire study period. Expected Results: The test denture adhesive should increase significantly the complete maxillary dentures maximum dislodgement force over the control (without denture adhesive) in subjects. |