| CTRI Number |
CTRI/2024/05/067729 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check Retention Of Complete Denture Using Digital Technologies |
|
Scientific Title of Study
|
A Comparative Evaluation Of Retention And Fit Of Complete Denture Fabricated using Conventional And CAD/CAM Methods |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirti Lochav |
| Designation |
PG STUDENT |
| Affiliation |
SGT University |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road, Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8851817420 |
| Fax |
|
| Email |
kirtilochav7275@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupender Yadav |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road, Gurugram Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8743019484 |
| Fax |
|
| Email |
bhupender.yadav@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupender Yadav |
| Designation |
Professor |
| Affiliation |
SGT University |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road, Gurugram Haryana
HARYANA
122505
India |
| Phone |
8743019484 |
| Fax |
|
| Email |
bhupender.yadav@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| Room No 103, Department of Prosthodontics Crown And Bridge And Oral Implantology, Faculty of Dental Sciences, Chandu-Bhudera, Gurgaon- Badli Road, Gurugram,Haryana, 122505 |
|
|
Primary Sponsor
|
| Name |
Dr Kirti Lochav |
| Address |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculy of dental sciences, SGT University,Budhera, Gurugram Badli road, Gurugram, Haryana 122505 |
| 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 |
| Dr Kirti Lochav |
SGT University |
Room no. 103, Department of prosthodontics, crown and bridge and oral implantology, Faculty of Dental Sciences, SGT university, Budhera, Gurugram Badli Road, Gurugram Haryana
Gurgaon
HARYANA |
8851817420
kirtilochav7275@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SGT Dental College, Hospital and Research Institute (IEC-SGTDCHRI) |
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 |
CAD/CAM dentures |
Checking the fit and retention of dentures fabricated using CAD/CAM techniques at the time of insertion |
| Comparator Agent |
Conventional dentures |
Checking the fit and retention of dentures fabricated using conventional techniques at the time of insertion |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Completely edentulous in the maxillary and mandibular arch.
2.Patient willing to participate and sign the informed consent
|
|
| ExclusionCriteria |
| Details |
Patients having undercuts of more than 2mm
• Presence of ridge and soft tissue pathology.
• History of taking medication that would alter the quantity and quality of saliva
• Patients having flabby ridge
• Patients having hyposalivation
• Patients having poor neuromuscular control |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The peak retention force of complete denture fabricated using milled, printed would be more than conventionally cured denture measured using digital force gauge.
|
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The fit of complete denture fabricated using milled, printed would be better than conventionally cured dentures checked using comparison software program (Geo magic) |
1 Year |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2024 |
| 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="1"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Dentures have been an age old treatment option for edentulous patients . Conventional dentures have been used since over more than a century , often returning with complaints of fit and retention. to overcome this, newer technologies are at hand today like CAD/CAM to fabricate digital dentures providing superior fit and retention. this study enrolling 10 patients aims to determine a particular fabrication method provides both superior fit and retention in complete dentures. |