| CTRI Number |
CTRI/2024/01/061556 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
cross sectional study |
| Study Design |
Other |
|
Public Title of Study
|
OCCLUSAL EVALUATION OF TOOTH/TEETH SUPPORTED RESTORATIONS –A POST RESTORATION QUANTITATIVE ANALYSIS |
|
Scientific Title of Study
|
OCCLUSAL EVALUATION OF TOOTH/TEETH SUPPORTED RESTORATIONS –A POST RESTORATION QUANTITATIVE ANALYSIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashika |
| Designation |
Postgraduate student |
| Affiliation |
Sri Siddhartha dental college and hospital |
| Address |
Department of Prosthodontics and Crown & Bridge
Room number 4
Sri Siddhartha dental college & hospital
agalakote
B H Road
tumkur 07
Tumkur KARNATAKA 572107 India |
| Phone |
8105092461 |
| Fax |
|
| Email |
ashika.maruthi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Ramesh chaudhary |
| Designation |
Proffesor |
| Affiliation |
Sri Siddhartha dental college and hospital |
| Address |
Department of Prosthodontics and Crown & Bridge
Room number 4
Sri Siddhartha Dental College & Hospital
agalakote
Tumkur KARNATAKA 572107 India |
| Phone |
9845206898 |
| Fax |
|
| Email |
drramco@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ashika |
| Designation |
postgraduate student |
| Affiliation |
sri siddhartha dental college and hospital |
| Address |
department of prosthodontics and crown & bridge
Room number 4
sri siddhartha dental college & hospital
agalakote
Tumkur KARNATAKA 572103 India |
| Phone |
8105092461 |
| Fax |
|
| Email |
ashika.maruthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Siddhartha dental college and hospital |
|
|
Primary Sponsor
|
| Name |
AshikaM |
| Address |
sri siddhartha dental college and hospital
agalkote b h road
tumkur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pooja pandurangi |
Sri Siddhartha Dental College and Hospital
Agalkote B H Road
tumkur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAshika |
Sri Siddhartha Dental College and Hospital |
Department of Prosthodontics and Crown & Bridge
Room number 4
Sri Siddhartha Dental College & Hospital
Agalakote Tumkur KARNATAKA |
8105092461
ashika.maruthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age from 18-60 years males and females
people having posterior crown/bridges apposing natural teeth and restored within 1 year
no relatively obvious tmj abnormalities
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are restored within one year
The patient having bridge in the posterior region
Patient having no relatively obvious TMJ abnormalities
Prosthesis opposing should be natural teeth
All Full crown restorations considered
Patients belonging to both genders considered
|
|
| ExclusionCriteria |
| Details |
Patients having prostheses opposing the restoration
Patients having long-span bridges in the posterior region.
Patients having TMJ-related problems
Patients restored more than a year of restoration
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the occlusal discrepancy using t scan system in the patients |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the relation between patient perception & t scan report on occlusal discrepancies |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
24/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/01/2024 |
| 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 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
|
Controlling
occlusal forces is the main focus of occlusal adjustments and restorative
dentistry, aiming to ensure their effective management. Despite the dentist’s
unwavering commitment to this objective, challenges related to imbalances in
occlusal forces continue to persist.
Achieving
optimal force distribution can significantly reduce the stress exerted on
teeth, dental implants, and restorative materials. To visualize the occlusal
contacts, different inks, and films are employed, aiding in making informed
decisions regarding adjustment therapy. However, these decisions often rely on
the subjective interpretation of the operator regarding the force experienced
at each contact point.
By
utilizing a computerized occlusal analysis system (T-Scan II, Tekscan Inc. S.
Boston, MA, USA), operators can employ a measurement-based approach to obtain
objective data on occlusal contact relative force in real time. This advanced
system has been proven to enhance the process of achieving refined occlusal
force equalization. The entire system affords the operator qualitative and
quantitative occlusal data, from which occlusal adjustment therapy decisions
can be measurably discerned.
Thus this
short study evaluates the occlusal discrepancies in patients with 3 unit metal-ceramic
restorations using T scan |