| CTRI Number |
CTRI/2020/10/028609 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Digital verification of dental occlusal correction. |
|
Scientific Title of Study
|
To comparative evaluation of the articulating paper method and with that of T-scan system for achieving implant protected occlusion. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramesh chowdhary |
| Designation |
Clinical chief |
| Affiliation |
Professor, Rajarajeswari dental college |
| Address |
no-3, 21st main, vijaynagar
Bengaluru
Rajarajeswari dental college and hospital
Bengaluru
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
drramc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh chowdhary |
| Designation |
Clinical chief |
| Affiliation |
Professor |
| Address |
Branemark Osseointegration centre India
No-3 , 21st main
Vijaynagar
Rajarajeswari dental college and hospital
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
drramc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramesh chowdhary |
| Designation |
Clinical chief |
| Affiliation |
Braneamark Osseointegration Center India |
| Address |
no-3, 21st main, vijaynagar
Bengaluru
no-3, 21st main, vijaynagar
Bengaluru
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
drramc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Branemark Osseointegration Center India
No 3, 21 main
Vijaynagar
Bengaluru-560040 |
|
|
Primary Sponsor
|
| Name |
Ramesh Chowdhary |
| Address |
no-3, 21st main, Vijaynagar , Bengaluru |
| Type of Sponsor |
Other [Brånemark Osseointegration centre india ] |
|
|
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 |
| Ramesh chowdhary |
BOCINDIA |
No-3, 21st main, vijaynagar
Bangalore
KARNATAKA |
9845206898
drramc@yahoo.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 |
| Healthy Human Volunteers |
Edentulous in upper and lower arches |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Articulating paper |
Occlusion high points will be checked with articulating paper |
| Intervention |
occlusion check by T scan |
all the patients will be checked for their patients with T scan |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Partially edentulous patients
posterior edentulism
opposing natural teeth |
|
| ExclusionCriteria |
| Details |
Completely edentulous
bruxism |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome variable measured was survival rates of implants placed simultaneously in elevated maxillary sinus with or without bone grafts |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome variable was amount of endo sinus bone gain and marginal bone loss around the implants placed in elevated maxillary sinus region with or without bone grafts. |
three months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
no yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Quantitative occlusal analysis techniques have been developed to overcome the limitations of qualitative assessments.9,10 The current advances in computer technologies have afforded dentists precision ways to examine occlusal contacts and muscle function. T-scan system analyses the order of occlusal contacts while simultaneously measuring the force percentage changes of those contacts, from the moment the teeth first begin making occlusal contact, all the way to maximum intercuspation.12-15 This prospective study was designed to compare and evaluate, occlusal high points recorded with that of articulating paper and comparing the same with the high points recorded by quantitative analysis, the T-scan |