CTRI Number |
CTRI/2020/01/022801 [Registered on: 16/01/2020] Trial Registered Prospectively |
Last Modified On: |
14/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Clinical Comparison of Preformed Zirconia and Stainless Steel Crowns in Young Permanent Teeth
|
Scientific Title of Study
Modification(s)
|
Comparative Assessment of the Clinical Efficacy in Preformed Zirconia Crown and Stainless Steel Crown in Permanent Molar Teeth in Pediatric Patients- Randomized Prospective Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Abhinav Talekar |
Designation |
Associate Professor |
Affiliation |
MA Rangoonwala College of Dentistry, Camp, |
Address |
MA Rangoonwala College of Dentistry, Camp, Pune
Pune MAHARASHTRA 411001 India |
Phone |
9503079151 |
Fax |
|
Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Abhinav Talekar |
Designation |
Associate Professor |
Affiliation |
MA Rangoonwala College of Dentistry, Camp, |
Address |
406, 2nd Floor ,Department of Peditric dentistry, MA Rangoonwala College of Dentistry, Camp, Pune
Pune MAHARASHTRA 411001 India |
Phone |
9503079151 |
Fax |
|
Email |
drabhinavtalekar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Abhinav Talekar |
Designation |
Associate Professor |
Affiliation |
MA Rangoonwala College of Dentistry, Camp, |
Address |
406, 2nd Floor, department of Pediatric Dentistry,MA Rangoonwala College of Dentistry, Camp, Pune
Pune MAHARASHTRA 411001 India |
Phone |
9503079151 |
Fax |
|
Email |
drabhinavtalekar@gmail.com |
|
Source of Monetary or Material Support
|
Nusmile Texas
3315 W 12th Street | Houston, TX | 77008
USA |
|
Primary Sponsor
|
Name |
Dr Abhinav Talekar |
Address |
M A RAngoonwala Dental College Pune |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr AbhinavTalekar |
M A Rangoonwala college of dental science and research centre, Camp Pune 411001 |
406, 2nd Floor, Deparrtment of Pediatric Dentistry, MA Rangoonwala College of Dentistry, Camp, Pune Pune MAHARASHTRA |
9503079151
drabhinavtalekar@gmail.com |
Dr AbhinavTalekar |
Talekar Children Dental Care |
off no 19 , Kumar Pavilion, East Street , Camp, Pune Pune MAHARASHTRA |
9503079151
drabhinavtalekar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
ETHICS COMMITTEE OF M.C.E. SOCIETY |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Stainless Steel Crowns |
3m Espe USA |
Comparator Agent |
zirconia |
3 m Espe. Nusmile USA |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
14.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria:
1) Requirement of placement of crowns on permanent molar after endodontic treatment
2) Teeth required for multi surface restoration followed by crown
3) Permanent second molar is erupting
4) Opposite teeth present
|
|
ExclusionCriteria |
Details |
Exclusion criteria:
1) Teeth with poor prognosis
2) Patient refused to participate
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Both crowns are having equal clinical performance.
Methhodology: MOdified USPHS criteria |
One week, 3 months, 6 months, 12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Zironia crowns do not affect eruption of second molar
Methodology:
Intraoral Periapical Radiograph
Clinical Picture |
One week, 3 months, 6 months, 12 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/02/2020 |
Date of Study Completion (India) |
25/03/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
“Clinical assesment of permanent molar zirconia crowns†Aims: 1) to assess clinical efficacy of permanent molar crowns 2) to assess the eruption path of second molar 3) to check clinical time required for placement of crown 4) to assess the opposite teeth wear over the period of time Methodology:Inclusion criteria: 1) requirement of placement of crowns on permanent molar after endodontic treatment 2) teeth required for multisurface restoration followed by crown 3) permanent second molar is erupting 4) opposite teeth present Exclusion criteria: 1) teeth with poor prognosis 2) patient refused to participate Procedure: Total no of teeth 50 prrmanent molar crowns ( nusmile zirconia 1) preoperative x ray 2) local anesthesia 3) rubber dam application 4) tooth preparation 5) try in with pink crown 6) check bite 7) cementation with resin gic (nusmile biocem) 8) follow up with (clinical pictures and x rays) A) 3 months B) 6 months C) 12 months 9) 3d scan of impression with opposite teeth with every follow up Materials required: 1) local anesthesia 2) rubber dam kit 3) burs Materials required from company: 1) total 50 number of zirconia crowns 2) nusmile biocem gic |