| CTRI Number |
CTRI/2024/02/062466 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical performance of stainless steel caps for milk teeth compared with 3D printed caps |
|
Scientific Title of Study
|
Evaluation of clinical performance of Stainless steel crowns and 3D Printed resin crowns in primary molars of children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bollepalli Bhavana |
| Designation |
Postgraduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3, Room No: 5
Department of Pedodontics and Preventive Dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9581681515 |
| Fax |
|
| Email |
bhavana.bollepalli@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uloopi KS |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3, Room No: 5
Department of Pedodontics and Preventive Dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9666404455 |
| Fax |
|
| Email |
uloopiks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitanya Penmatsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 3, Room No: 5
Department of Pedodontics and Preventive Dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9908217142 |
| Fax |
|
| Email |
chaitanyap@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
Bollepalli Bhavana |
| Address |
Block 3, Room No: 5
Department of Pedodontics and Preventive Dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
|
| 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 |
| DrBollepalli Bhavana |
Vishnu Dental College |
Block 3, Room No: 5
Department of Pedodontics and Preventive Dentistry
Vishnu Dental College
Vishnupur
Bhimavaram
West Godavari
ANDHRA PRADESH |
9581681515
bhavana.bollepalli@vdc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE VISHNU DENTAL COLLEGE, BHIMAVARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D Printed Resin Crowns(Acuretta resin) |
10 days after pulpectomy, tooth preparation will be done with occlusal reduction of 1.5mm, Buccal, lingual and proximal wall preparation of 0.8 to 1.0mm using TR-11 with chamfer finish line and convergence angle of 6 degrees and it is followed by digital impressions using 3Shape Trios scanner and designing of crowns using CAD(3Shape) software and printing of resin crowns(Acuretta resin) using 3D printer Phrozen Mini 4K using Chitu box software will be done. This crown will be cemented using type I GIC (Hy-bond glasionomer CX-Smart, Japan). Follow up evaluation of the crowns will be done at 6 and 12 months intervals for survival rate of crowns, crown retention and gingival health using Loe and Silness index. Duration of crown is expected upto 12 years of patient age |
| Comparator Agent |
Preformed Stainless steel crowns(KIDS Crown) |
10 days after pulpectomy, Occlusal reduction of 0.5mm with no.330 bur, Interproximal slicing using no.169L bur with feather edge finish line will be done. Selection of appropriate size preformed stainless steel crown will be done and checked for trial fit on tooth. Trimming, festooning and crimping of crowns will be done for proper fit.Cementation of crown will be done using type I GIC (Hy-bond glasionomer CX-Smart, Japan) following radiographic confirmation for proper fit. Follow up evaluation of the crowns will be done at 6 and 12 months intervals for survival rate of crowns, crown retention and gingival health using Loe and Silness index. Duration of crown is expected upto 12 years of patient age |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group 6 to 9 years
2. Children with bilateral pulpectomy treated primary second molars will be included. |
|
| ExclusionCriteria |
| Details |
1.Pulpectomy treated teeth with decay extending beneath the free gingival margin.
2.Medically compromised children
3.Children with parafunctional habits.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Survival rate of crowns
2.Crown retention
|
1.Survival rate of crowns - 6months & 12 months
2.Crown retention - 6months & 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Gingival health using Loe and Silness index.
|
1.Gingival health using Loe and Silness index -6months & 12 months
|
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
12/02/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The aim of the study is to compare the clinical performance of stainless steel crowns and 3D printed resin crowns in primary molars of 6 to 9 year old children. A total of 32 children with bilateral pulpectomized teeth will be selected from the outpatient department of Pedodontics and Preventive Dentistry, Vishnu Dental College, Bhimavaram. In group A preformed Stainless steel crowns will be placed and in group B 3D printed resin crowns will be given. The study is interventional prospective study. Computer generated randomized method will be employed for sampling. Both the groups will be evaluated for survival rate, crown retention and gingival health at time interval of 6 months and 12 months. The data will be analyzed individually for all the patients. There is no conflict of interest. |