| CTRI Number |
CTRI/2021/07/035238 [Registered on: 29/07/2021] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to compare the effectiveness of a denture sticking paste and a denture sticking powder in patients using complete dentures |
|
Scientific Title of Study
|
Clinical efficacy of two denture adhesives among complete denture patients: A cross-over randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janaki Ramesh |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental College and Hospital, Hyderabad |
| Address |
Room No.227, Department of Prosthodontics, Government Dental College and Hospital, Afzal Gunj, Hyderabad
Hyderabad
TELANGANA
500012
India |
| Phone |
9962005955 |
| Fax |
|
| Email |
januramesh10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sreeramulu |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital, Hyderabad |
| Address |
Room No.227, Department of Prosthodontics, Government Dental College and Hospital, Afzal Gunj, Hyderabad
Hyderabad
TELANGANA
500012
India |
| Phone |
9052030499 |
| Fax |
|
| Email |
drsreeramulub@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineela Pyla |
| Designation |
Post Graduate student |
| Affiliation |
Government Dental College and Hospital, Hyderabad. |
| Address |
Room No.227, Department of Prosthodontics, Government Dental College and Hospital, Afzal Gunj, Hyderabad
Hyderabad
TELANGANA
500012
India |
| Phone |
9542082790 |
| Fax |
|
| Email |
vineelapyla123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Janaki Ramesh |
| Address |
Room No.227, Department of Prosthodontics, Government Dental College and Hospital, Afzal Gunj, Hyderabad |
| 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 |
| Janaki Ramesh |
Government Dental College and Hospital, Hyderabad |
Room No.227, Department of Prosthodontics, Government Dental College and Hospital, Afzal Gunj, Hyderabad
Hyderabad
TELANGANA |
9962005955
januramesh10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, OSMANIA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Denture adhesive powder - FIXON,
Denture adhesive paste - POLIDENT |
Patient will be advised to sprinkle the denture adhesive powder or apply the denture adhesive paste on the intaglio surface of the denture and advised to use it for 7 days |
| Comparator Agent |
No denture adhesive, dentulous patients |
masticatory efficiency of the patients with complete dentures will be measured at baseline without the use of any denture adhesives, masticatory efficiency of the patients with atleast 24 teeth present will be measured at baseline |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
For edentate group:
Adults with completely edentulous maxilla and mandible with satisfactory denture bearing area according to Kapur KK (1967) and new prosthesis placed atleast 1 month before but not more than 1 year before the study with the dentures meeting the clinically good dentures criteria of Kapur KK (1967).
For dentate group:
Adults with at least 24 teeth present.
|
|
| ExclusionCriteria |
| Details |
For edentate group:
1. Presence of any active oral pathology.
2. Known allergy to any of the components in the adhesives used.
3. Presence of uncontrolled systemic disease or any physical or mental disability.
For dentate group:
1. Presence of any active oral pathology.
2. Presence of uncontrolled systemic disease or any physical or mental disability.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Masticatory efficiency assessed by the sieve method (Edlund and Lamm Index) |
0,7 and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction assessed by a specially designed questionnaire. |
7 and 21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2021 |
| Date of Study Completion (India) |
15/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
https://doi.org/10.21276/ujds.2023.9.3.2 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is an increase in the population of geriatric patients in our
country many of whom lack access to basic dental care which is linked to an
increased incidence of tooth loss. In this scenario, even though there are various
fixed implant-supported prosthetic options available, most of the completely
edentulous patients cannot afford them and are ultimately provided with complete
dentures. Complete dentures sometimes lack sufficient retention as a result of
compromised anatomical situations like resorbed ridges. In such cases, the use
of denture adhesives may improve retention and stability and thereby provide
better masticatory function to these patients. However, there is insufficient knowledge among practitioners and
patients regarding the uses and the benefits of these materials. There are also
very few studies assessing the masticatory efficiency following the use of commercially
available denture adhesives especially in the Indian population. Hence, this study was designed to compare the masticatory efficiency and satisfaction
of complete denture wearers using two different forms of commercially available
denture adhesives and also compare them with the baseline values without denture adhesive and the masticatory efficiency of dentate patients serving as a control. |