| CTRI Number |
CTRI/2025/05/087229 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Three different Crown Types for Looks and Comfort for children and parents |
|
Scientific Title of Study
|
Comparative clinical evaluation, patient and parental satisfaction of pediatric anterior preformed Zirconia crown, Bioflx crown and Resin composite strip crown. |
| 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 Dipali Vetal |
| Designation |
Post graduate student |
| Affiliation |
Sri siddhartha dental collge tumkur |
| Address |
Room No : 6
Department of pedododntics
Sri siddhartha dental collge and hospital , agalkote , B.H road tumkur- 572107, Karnataka ,India
Tumkur
KARNATAKA
572107
India |
| Phone |
9112275055 |
| Fax |
|
| Email |
dipali.vetal10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothsna V Setty |
| Designation |
Professor and H.O.D |
| Affiliation |
Sri siddhartha dental collge tumkur |
| Address |
Room No : 6
Department of pedododntics
Sri siddhartha dental collge and hospital , agalkote , B.H road tumkur- 572107, Karnataka ,India
Room No : 6
Department of pedododntics
Sri siddhartha dental collge and hospital , agalkote , B.H road tumkur- 572107, Karnataka ,India
Tumkur
KARNATAKA
572107
India |
| Phone |
9112275055 |
| Fax |
|
| Email |
jyothsnasrikanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Vetal |
| Designation |
Post graduate student |
| Affiliation |
Sri siddhartha dental collge tumkur |
| Address |
Room No : 6
Department of pedododntics
Sri siddhartha dental collge and hospital , agalkote , B.H road tumkur- 572107, Karnataka ,India
Tumkur
KARNATAKA
572107
India |
| Phone |
9112275055 |
| Fax |
|
| Email |
dipali.vetal10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Siddhartha Dental and Hospital
Room No : 6
Department of pedododntics
Sri siddhartha dental collge and hospital , agalkote , B.H road tumkur- 572107, Karnataka ,India |
|
|
Primary Sponsor
|
| Name |
Dr Dipali Vetal |
| Address |
Room No: 6
Department of Pedodontics
Sri siddhartha dental college and hospital
B.H .Road ,Tumkur ,Karnataka,India -572107 |
| Type of Sponsor |
Other [self (Am the post graduate student am the primary sponsor for this research)] |
|
|
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 Dipali vetal |
Sri Siddhartha Dental College and Hospital |
Room No:6
Department of Pedodontics
Sri Siddhartha Dental College and Hospital
B.H.Road, Agalakote,Tumkur,Karnataka,India-572107
Tumkur
KARNATAKA |
09112275055
dipali.vetal10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Siddhartha Dental College Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioflex crown , Zirconia crown
|
Evaluating the clinical success
of bioflex , zirconia crown and comparing with the control group |
| Comparator Agent |
Strip crown |
Evaluating the clinical success of bioflex , zirconia crown and comparing with the control group |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy 3-5 year old children
2. Anterior pulpectomy treated teeth (maxillary incisors)
3. No history of systemic illness
4. No dental developmental anomalies
5. Cooperative patient who had behavioral rating “Positive” or “Definitely positive “on frankle behavior classification scale.
6. Patient who are willing for treatment
|
|
| ExclusionCriteria |
| Details |
Teeth with proximity to exfoliation
2. Resorption of root
3. Anxiety and lack of cooperation
4. Bruxism
5. Patient with special health care need
6. Presence of teeth wear
7. Patient and/or parent unwilling for treatment
8. Grossly decayed tooth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Aesthetic Evaluation (Color Match and Surface Gloss):
Comparison of how well each crown type matches natural teeth.
|
After Pulpectomy- placement of crown
1 week,3month ,6 month,9 month - evaluation each follow up checking the clinical performance and patient and parental satisfaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tooth decay is one of the common disease affecting children. So we compare the three different anterior crown (preformed zirconia crown, bioflx, and anterior resin strip crown), clinical evaluation and patient, parental satisfaction. The clinical evaluation of crown is also important to decide which crown has the best success rate. |
After Pulpectomy- placement of crown
1 week,3month ,6 month,9 month - evaluation each follow up checking the clinical performance and patient and parental satisfaction |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/06/2025 |
| Date of Study Completion (India) |
12/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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)
|
Early childhood caries (ECC) is the silent epidemic citing almost 30% preschoolers having caries.[1] Early childhood caries (ECC) predominantly affects infants and can significantly impact the appearance of the children by causing decay in their primary anterior teeth.[2] Early childhood caries(ECC) remains a prevalent chronic multifactorial condition, particularly affecting children from socioeconomically disadvantaged background. The American Academy of Pediatric Dentistry (2002), defined Early childhood caries(ECC) as “the presence of one or more decayed( non- cavitated or cavitated lesions ), missing (due to caries ) or filled tooth surfaces in any primary tooth in a child 71 months of age or younger”.[3] When children experience broken or lost front teeth due to early childhood caries (ECC) it can significantly affect their appearance. Complete coronal restoration is recommended to replace deciduous teeth with two or more damaged surfaces. The choice of crown type for tooth rehabilitation is often left to the discretion of the parent.[4] In the last decayed, there has been a noticeable increase in parental engagement in selecting aesthetic dental treatments for their children. Among the popular choices for anterior aesthetic complete crown are strip and prefabricated zirconia crowns.[1] Rehabilitative dentistry has increasingly become the preferred approach over extraction for treating various primary teeth. Parents often assess the aesthetics, durability, and cost of therapy before approving any rehabilitation operation.[4] Two most widely used option for complete coronal restoration is anterior esthetic, the resin composite strip crown and preformed anterior zirconia crown. strip crown is often regarded as a most esthetic alternative for restoring deciduous anterior teeth.[2] The composite strip crown offers superior esthetic and ease of repair in case of crown fracture. It is considered the most sensitive option, moisture contamination from blood or saliva can disrupt bonding, and hemorrhage has the potential to alter the shade or color of material.[5] Zirconia crown boasts exceptional esthetics and relatively high durability so, zirconia crown have high level of approval of all esthetic option.[4] Drawback of zirconia restoration is the inability to crimp the crown for mechanical retention, inability to change the color, more tooth preparation required as compare with other anterior crown. Zirconia crown is highly expensive than other anterior crown.[1] Recently launched anterior bioflx crown in pediatric dentistry are flexible, durable, adaptable and combining both zirconia and stainless-steel properties.[6] However there are no clinical studies comparing anterior preformed zirconia crown, bioflx crown and resin composite strip crown. Hence, the present study will be conducted to evaluate comparative clinical performance, patient and parental satisfaction of pediatric anterior preformed zirconia crowns, bioflx crowns and resin composite strip crowns. |