| CTRI Number |
CTRI/2024/03/063769 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check bond reliability of peek coping with ceramic layering material compared to peek coping layered with composite |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Performance and In-Vitro Bond Reliability of Differently Surface treated Peek Copings Veneered with Ceramic Versus Composite |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Gupta |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rekha Gupta |
| Designation |
Professor and Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
DELHI
110002
India |
| Phone |
9654700952 |
| Fax |
|
| Email |
dr_rekhagupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sangeeta |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9717811732 |
| Fax |
|
| Email |
ahirsangeeta17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi: 110002
|
| Type of Sponsor |
Government medical college |
|
|
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 Rekha Gupta |
Maulana Azad Institute of Dental sciences |
Room 202, Department of Prosthodontics, Maulana Azad Institute of Dental Sciences, MAMC Complex, B.S. Zafar Marg, New Delhi
Central
DELHI |
9654700952
dr_rekhagupta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ceramic veneered PEEK |
Ceramic veneered PEEK copings surface treated with 50µm alumina particles and 98% sulfuric acid |
| Comparator Agent |
Composite veneered PEEK |
Composite veneered PEEK copings surface treated with 50µm alumina particles |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Teeth with no active periodontal or pulpal diseases.
2. Teeth should have antagonist teeth in proper occlusion. |
|
| ExclusionCriteria |
| Details |
Poor oral hygiene
Partially erupted posterior teeth
Maligned or improperly occluding or missing antagonist teeth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the bond strength of PEEK with ceramic and composite using different surface treatment options by evaluating the fracture rates at different time Interval |
To compare the bond strength of PEEK with ceramic and composite using different surface treatment options |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the bond strength of PEEK with ceramic and composite using different surface treatment options |
0,3,6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/03/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Brief Summary This study is a randomized, double-blind, parallel-group, trial
Comparing and evaluating clinical performance of ceramic veneered and composite veneered PEEK copings after different surface treatments for 9 months on 30 patients. The primary outcome will be that ceramic veneering over PEEK copings with different surface treatments can be used as an acceptable material in clinical conditions.
|