| CTRI Number |
CTRI/2024/05/067463 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
observational study on two types of crowns (stainless steel and nano-composite) in children to check their clinical success in milk back teeth |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Success Rate of Prefabricated Nano-Composite Crowns and Stainless Steel Crowns in Primary Molars: An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritika Tiwari |
| Designation |
1st year Post Graduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
Yenepoya Dental College
University Road
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8840705407 |
| Fax |
|
| Email |
Ritikatiwari1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Rao HT |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Pediatric and Preventive Dentistry
Yenepoya Dental College
University Road
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845085048 |
| Fax |
|
| Email |
drajayrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Tiwari |
| Designation |
1st year Post Graduate Student |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Pediatric and Preventive Dentitry
Yenepoya Dental College
University Road
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8840705407 |
| Fax |
|
| Email |
Ritikatiwari1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Dental College
University Road,
Deralakatte
Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Ritika Tiwari |
| Address |
Department of Pediatric and Preventive Dentistry
Yenepoya Dental College
University road
Deralakatte,
Mangaluru, Karnataka 575018 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Ritika Tiwari |
Yenepoya Dental College |
Department of Pediatric and Preventive Dentistry
Dakshina Kannada
KARNATAKA |
8840705407
ritikatiwari1999@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy 4-9 year old children requiring full coverage post-endodontic crowns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. 4–9-year-old children requiring post endodontic full coverage crowns on primary molars
2. Healthy children
|
|
| ExclusionCriteria |
| Details |
1. Children with any gingival and periodontal disease
2. Children with para-functional habits
3. Children with special needs and systemic diseases
4. Teeth with physiologic mobility
5. Teeth with inadequate crown structure
6. Teeth with missing antagonist tooth
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check crown retention, marginal integrity, gingival health, wear and tear of crown and wear and tear of antagonist tooth seen in prefabricated nano-composite crowns. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the aforementioned parameters to those of Stainless Steel crowns |
6 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Prefabricated Nano-Composite Crowns are a novel advancement in the field of pediatric dentistry, as the need for newer aesthetic replacements emerge. They are bio-inert and bio-functional crowns made to perfectly mimic the morphology of primary teeth in form and function. Made from laser sintered and vitrified nano composites, they claim to require minimal tooth preparation according to the manufacturers. This is a Randomized Control Trial, and the aim of this study is to compare the clinical success rate of Prefabricated Nano-Composite Crowns with conventional Stainless Steel Crowns in primary molars. 42 teeth requiring full coverage crowns as post endodontic restorations in participants in the age group of 4-9 years will be recruited in this study. These 42 teeth will be divided into two groups, that is, Prefabricated Nano-Composite Crown Group and Stainless Steel Crown Group. Both the groups will be clinically assessed for retention of the crown, it’s marginal integrity, gingival health around the crown and wear and tear of the crown and the antagonist tooth, 6 months after placement of the crown. |