| CTRI Number |
CTRI/2025/03/082650 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to check how accurate is digital record of a patients bite for replacing missing teeth and how the record differs when there is a specific stop present on the last tooth in patients with one or two missing teeth. |
|
Scientific Title of Study
|
COMPARISON OF DIGITAL INTEROCCLUSAL RECORD ACCURACY AND OCCLUSAL DISCREPANCY ON TERMINAL ABUTMENT WITH AND WITHOUT PRESERVING VERTICAL STOP AN IN VIVO 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 Rupa G |
| Designation |
Post graduate Student |
| Affiliation |
Bapuji dental College and Hospital |
| Address |
Room No7, 2nd floor, Department of Prosthodontics and crown and bridge, Bapuji Dental College And Hospital
Davanagere KARNATAKA 577004 India |
| Phone |
09164097989 |
| Fax |
|
| Email |
drrupagopal006@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunitha N Shamnur |
| Designation |
Professor |
| Affiliation |
Bapuji dental College and Hospital |
| Address |
Room No7, 2nd floor, Department of Prosthodontics and Crown and Bridge, Bapuji Dental College And Hospital
Davanagere KARNATAKA 577004 India |
| Phone |
9449822941 |
| Fax |
|
| Email |
sunithanshamnur@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rupa G |
| Designation |
Post graduate sStudent |
| Affiliation |
Bapuji dental College and Hospital |
| Address |
Room No7,2nd floor, Department of prosthodontics and crown and bridge, Bapuji Dental College And Hospital
KARNATAKA 577004 India |
| Phone |
09164097989 |
| Fax |
|
| Email |
drrupagopal006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji dental college and hospital, Post box No326, MCC B block, Davanagere, Karnataka, India Pincode-577004 |
|
|
Primary Sponsor
|
| Name |
Dr Rupa G |
| Address |
Bapuji Dental College And Hospital,Davangere-577001 |
| 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 Rupa G |
Bapuji dental College and Hospital |
Room No7,2nd floor, Department of Prosthodontics and Crown and bridge Davanagere KARNATAKA |
9164097989
drrupagopal006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Review Board,Bapuji Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with missing teeth |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
vertical stop |
preserving A vertical stop on the cuspal surface of the last tooth and recording the interocclusal bite by intraoral scan |
| Comparator Agent |
vertical stop will be eliminated |
The preserved stop vertical stop will be eliminated like a coneventional preparation and compared with the intervention |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH ONE OR TWO MISSING TEETH IN MANDIBULAR POSTERIOR REGION WITH ONE TOOTH PRESENT POSTERIOR TO MISSING REGION |
|
| ExclusionCriteria |
| Details |
Patients with a history of TMJ dysfunction or myofascial pain dysfunction syndrome
patients with limitation of mandibular movement
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the accuracy of interocclusal record recorded using intra oral scanner in a terminal abutment |
The outcome will be assessed at baseline after prosthesis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the accuracy of occlusion obtained preserving the vertical stop |
The occlusion will be assessed at baseline |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
27/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Various studies have determined the accuracy and precision of the use of intraoral scanners (IOS) in clinical practice. However studies on accuracy in reproducing the inter-occlusal contacts in the terminal abutments is scarce. When the posterior most tooth is considered as the abutment for the fabrication of a fixed prosthesis, which is otherwise known as terminal abutment. There are challenges encountered in accurate transfer of the inter occlusal record to the articulator, as there is loss in the tripod configuration to articulate the cast due to improper seating of the condyle and loss of proprioception leading to eccentric contacts. By preserving the distal cusp as a vertical stop in a full coverage preparation, the tripod relation can be achieved. The intention of this clinical study is to assess the occlusal discrepancy and accuracy of intraoral scanners in recording the inter-occlusal records on a terminal abutment by preserving the centric stop and compare them with the conventional method. |