| CTRI Number |
CTRI/2022/03/040719 [Registered on: 02/03/2022] Trial Registered Prospectively |
| Last Modified On: |
01/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trail to study Occlusal contact load and chewing or Biting efficency in computer created prosthesis to Conventional Hand layered prosthesis |
|
Scientific Title of Study
|
An Occlusal contact load and chewing efficency in to CAD created occlusal Anatomy to Conventional Hand layered Ceramic Anatomy in FPD using Digital Occlusal Analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh Venugopalan |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Prosthodontics,
Saveetha Dental College and Hospitals,
Saveetha Institute of Medical and Technical Sciences(SIMATS)
162,Poonamalle High Road,
Chennai,
Tamilnadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9543192858 |
| Fax |
|
| Email |
suresh@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Venugopalan |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Prosthodontics,
Saveetha Dental College and Hospitals,
Saveetha Institute of Medical and Technical Sciences (SIMATS)
162,Poonamalle High Road,
Chennai,
Tamilnadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9543192858 |
| Fax |
|
| Email |
suresh@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Venugopalan |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Prosthodontics,
Saveetha Dental College and Hospitals,
Saveetha Institute of Medical and Technical Sciences (SIMATS)
162, Poonamalle High Road,
Chennai,
Tamilnadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9543192858 |
| Fax |
|
| Email |
suresh@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Next gen Realtors Pvt ltd, Saveetha dental college and Hospitals |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals,162, Poonamalle High Road,
Velappanchavadi,Chennai,Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gowtham Neppala |
Saveetha Dental College and Hospitals |
clinic 24,Department of Prosthodontics,Saveetha Dental College and Hospitals,Poonamalle High Road ,Chennai
Thiruvallur
TAMIL NADU |
8466061455
gowtham.neppala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD created Monolithic crowns |
Group -1 is Patient with CAD created Monolithic crowns
|
| Comparator Agent |
Feldspathic Crowns |
Group-2 is patient with Feldspathic crowns |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
missing teeth in any arches, Teeth with vertical stop, patients requiring Fixed prosthesis |
|
| ExclusionCriteria |
| Details |
Patient requiring multiple Fixed prosthesis,Teeth with no vertical stop,
Multiple missing teeth in both arches |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
occlusal contact in percentage
Disocclusion timing during excursive movements
and chewing efficency |
Base line, 1 week and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
occlusal contact area ,Maximum intercuspation ,CAD created Monlithic crowns and Hand layered crowns
|
Base line,1 week and 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
19/09/2022 |
| 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="8"
Days="9" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Occlusal analyzes using T-scan the order of the occlusal contacts while simultaneously measuring the force percentage changes of those same contacts, from the moment the teeth first begin making occlusal contact, all the way through to maximum intercuspation. Therefore, it can assess the initial occlusal contact, the order that all the occlusal contacts occur, and the amount of relative occlusal force loading each contact. It enables us to assess the force changes, all during the process of contact evolution
|