| CTRI Number |
CTRI/2024/03/064077 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study implant occlusion in partial edentulous patient and checking the occlusion using T-scan system and articulating paper. |
|
Scientific Title of Study
|
A clinical trial to study implant occlusion in partial edentulous patient and checking the occlusion using T-scan system and articulating paperâ€. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
prajna p shetty |
| Designation |
assosiate professor |
| Affiliation |
branemark osseointegration centre |
| Address |
Branemark osseointegration centre,india.
department of prosthodontics
4th floor,
Branemark osseointegration centre, Marenahalli, Vijayanagar, Bangalore, India.
Bangalore
KARNATAKA
560040
India |
| Phone |
9880200298 |
| Fax |
|
| Email |
prajna.shetty21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chowdhary |
| Designation |
professor |
| Affiliation |
branemark osseointegration centre, india |
| Address |
Branemark osseointegration centre, india.
department of prosthodontics,
4th floor,
Branemark osseointegration centre, Marenahalli, Vijayanagar, Bangalore, India.
Bangalore
KARNATAKA
560040
India |
| Phone |
9845206898 |
| Fax |
|
| Email |
drramc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Chowdhary |
| Designation |
professor |
| Affiliation |
branemark osseointegration centre, india |
| Address |
Branemark osseointegration centre, india.
department of prosthodontics,
4th floor,
Branemark osseointegration centre, Marenahalli, Vijayanagar, Bangalore, India.
Bangalore
KARNATAKA
560040
India |
| Phone |
9845206898 |
| Fax |
|
| Email |
drramc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| branemark osseointegration centre, india
department of prosthodontics
4th floor,
marenahalli, vijayanagar, bangalore, india |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [] |
|
|
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 prajna p shetty |
branemark osseointegration centre, india |
department of prosthodontics
4th floor,
Branemark osseointegration centre, Marenahalli, Vijayanagar, Bangalore, India.
Ph no: 9880200298
Bangalore
KARNATAKA |
9880200298
prajna.shetty21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BOCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
articulating paper |
the occlusal correction done with digital device is compared with the occlusal correction done with articulating paper and checked if there is any changes in the overall well being, masticatory efficiency and oral health of the patient.
total duration: 30 min |
| Intervention |
T-Scan Novus system will be used to digitally interpret the occlusion |
it is a digital device to quantify the occlusion and help the dentist to harmonize occlusion and disclusion time quantitatively.
total duration: 30 min. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Partially edentulous patients will be selected for the study with atleast three missing teeth that has been restored with implant prosthesis.
2. Adult males and females with 25-65 years of age will be selected for the study.
3. The patient must have been already partially restored with implant prosthesis in one or either arch.
|
|
| ExclusionCriteria |
| Details |
1. Completely edentulous patients were excluded from the study.
2. Periodontally compromised patients were excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: t-scan will harmonize occlusion better , Time-points: 4 week( 4 visit) |
Outcome Name: t-scan will harmonize occlusion better , Time-points: 4 week( 4 visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: t-scan will harmonize occlusion better , Time-points: 1 week (1 visit). |
1 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prajna.shetty21@gmail.com].
- For how long will this data be available start date provided 30-12-2024 and end date provided 30-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Occlusion is the principal concern of prosthetic and restorative dentistry. Occlusal interferences are injurious functional problems that become apparent after the treatment of the prosthesis. To register the occlusal-articulation relationship, various types of occlusion analyzers are used. They are broadly divided into qualitative and quantitative occlusion analyzers. Qualitative analyzers are high-spot indicator, articulating film, metallic shim stock film, articulating silk, and articulating paper. These analyzers are the most commonly used materials for registering the occlusion due to their lower cost and ease of use. The limitations of these analyzers are that only the localization of the occlusal contact points is possible, the occlusal contact sequence cannot be registered, intraorally they should be used only once, and prior to testing, the teeth should be dried. Quantitative indicators are the T-scan 10 occlusal analysis system, occlusal sonography, pressure-sensitive films, and virtual technology.
The aim of the study was to determine the effect of T-scan system on occlusal measurement, clinical execution, and to analyze and discuss the intricacies of occlusion especially while restoring partially edentulous patients to give clinicians accommodating thoughts in the dynamic cycle of situation where this usage of T-scan is significant in rehabilitating different types of mixed dentition cases where tooth and implant-supported prostheses are both harmoniously functioning in the oral cavity. |