| CTRI Number |
CTRI/2024/01/061968 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking Retention of denture bases fabricated with three different technichques |
|
Scientific Title of Study
|
: A Comparative Evaluation of Retention of Record Bases fabricated with Conventional Compression Molding, CAD- CAM Milling, and 3D-printing– An In vivo Pilot Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapna B V |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Prosthodontics and Crown and Bridge
Manipal college of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880359889 |
| Fax |
|
| Email |
swapna.bv@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapna B V |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Prosthodontics and Crown and Bridge
Manipal college of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880359889 |
| Fax |
|
| Email |
swapna.bv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapna B V |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Prosthodontics and Crown and Bridge
Manipal college of Dental Sciences
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880359889 |
| Fax |
|
| Email |
swapna.bv@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of higher education, Manipal, Udupi,Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Swapna B V |
| Address |
Department of Prosthodontics and crown and bridge
Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kavishma Sulaya |
Department of Prosthodontics and crown and bridge
Manipal College of Dental Sciences Manipal |
| Dr Vaishnavi M Nayak |
Department of Prosthodontics and crown and bridge Manipal College of Dental Sciences Manipal |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swapna B V |
Manipal College Of Dental Sciences |
Room no 5, Department of Prosthodontics, Manipal College Of Dental Sciences
Manipal
Udupi
KARNATAKA |
9880359889
swapna.bv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Kasturba Medical College and Kasturba Hospitals |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with well-formed edentulous maxillary arch
2. Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with excessive maxillary ridge resorption.
2. Patients with a bony undercut of more than 2 mm in the maxillary ridge
3. Patients with flabby ridge, papillary hyperplasia, epulis fissuratum.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention values of three groups will be compared to see which group exhibits greater retention values |
Baseline retention values will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The best technique will be employed clinically |
Baseline
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Most patients receiving complete denture treatment are elderly, and multiple visits to the dental clinic make it very strenuous. There is a need for a newer technique that will produce similar results as the conventional technique with reduced duration and effort. In recent years, digital impressions have been used for the fabrication of complete dentures. Digital impressions eliminate patient discomfort related to conventional impression-making, reduce distortion of impressions, limit the risk of infection, simplify workflow for the involved personnel, and also reduce the time spent on impression processing and transportation.Recent advancements in digital impressions claim to reproduce images like the conventional method. This can be verified by a comparative evaluation of the retention of the prosthesis fabricated using these methods. This study is done to evaluate and compare the retention and adaptation of denture bases fabricated using conventional methods, 3D printing, and CAD/CAM-milled denture bases. A total of ten patients visiting the Department of Prosthodontics, MCODS Manipal, for complete dentures fulfilling the inclusion criteria will be included in the study. On each participant conventional impression and digital scanning will be performed and record bases will be fabricated using above mentioned techniques. A platform will be designed with a 45-degree inclination. A dislodging force will be applied via a dynamometer connected to a hook. This will simulate the dislodging force thus, clinically testing record base retention. The retention offered by the conventional record base, CAD-CAM milled record, and 3D printed bases from the modified intraoral scan will be compared by two evaluators. Retention values obtained from the denture bases from all three groups will be analyzed. Retention values of three groups will be compared to see which group exhibits greater retention values. If retentive values of the fabricated denture bases are similar to the conventional denture bases, then the digital method of fabrication can be used as a routine treatment option, thereby reducing patient appointment numbers and chair side time and increasing efficiency. |