| CTRI Number |
CTRI/2025/09/095227 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on digital crowns treated with either chemical or sand particles for the evaluation of the dislodgement, chipping-off, fractures on the milk tooth of children. |
|
Scientific Title of Study
|
Evaluation of the Clinical Performance of 3D Printed Resin Crowns modified by Mechanical and Chemical Surface Treatments of Intaglio Surface - A Split Mouth Randomised Controlled Trial |
| 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 Smritti Jaiswal |
| Designation |
First Year Postgraduate |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
7981601118 |
| Fax |
|
| Email |
smritti.j@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Penmatsa Chaitanya |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9908217142 |
| Fax |
|
| Email |
drchaitanyamds@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Penmatsa Chaitanya |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9908217142 |
| Fax |
|
| Email |
drchaitanyamds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,Vishnupur,Bhimavaram - 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Smritti Jaiswal |
| Address |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202 |
| Type of Sponsor |
Other [Self] |
|
|
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 Smritti Jaiswal |
Vishnu Dental College |
Department of Pedodontics and Preventive Dentistry, Second Floor, Block - III, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari District, Andhra Pradesh - 534202 West Godavari ANDHRA PRADESH |
7981601118
smritti.j@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, VISHNU DENTAL COLLEGE BHIMAVARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D Printed resin crowns |
3D Printed resin crowns on pulpectomised deciduous second molars |
| Comparator Agent |
Surface Treatment of the Intaglio surfaces of the 3D printed resin crowns |
Sandblasting versus Hydrofluoric Acid comparision |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1) Children of age 4 - 9 years.
2) Children with bilateral pulp therapy treated primary second molars.
3) Healthy and co-operative children.
4) Patients who are willing to be part of this study |
|
| ExclusionCriteria |
| Details |
1) Medically compromised children.
2) Children with para-functional habits.
3) Pulpectomy treated teeth with decay extending beneath the free gingival margin. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical performance of the crowns underwent two different surface treatments using USPHS criteria |
03,06,09,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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) |
Not Yet Recruiting |
|
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
|
In this study, children
of age 04 - 09 yrs who underwent bilateral pulp therapy treated primary second
molars who are healthy and co-operative and are willing to be part are been
included in the study,children who are medically compromised children and are
with para-functional habits. And pulpectomy treated teeth with decay extending
beneath the free gingival margin are been excluded from the study. Children coming to outpatient
block in Department of Pedodontics & Preventive Dentistry will be screened.
Based on inclusion and exclusion criteria, 20 children will be recruited into
study who underwent pulp therapy of the right and left milk tooth of the upper
or lower back tooth region with the help of Computer-generated sequence, the
children will be allocated into 2 groups using split mouth design. After doing the tooth preparation scanning using intraoral scanner then by the CAD-CAM
software crowns are designed and printed with 3D printers and prior to the cementation of the these 3d
printed resin crowns the surface treatment of intaglio surfaces will be done in one group mechanical surface
treatment with sandblasting and in another group chemical surface treatment
with hydrofluoric acid is done and are cemented to the tooth and their Clinical
performance are assessed at using U.S.P.H.S criteria at duration of 3,6,9,12
months.
|