| CTRI Number |
CTRI/2024/06/068687 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of stainless steel and hybrid resin polymer crowns |
|
Scientific Title of Study
|
Evaluation of clinical success and parental satisfaction following stainless steel versus hybrid resin polymer crowns of mandibular primary molars in 4-9 years old children: a split mouth randomized 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 Divya |
| Designation |
Postgraduate Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Dentistry Second floor OPD Building UCMS and GTB Hospital Dilshad Garden Delhi
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
dvsharmaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishi Tyagi |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Dentistry Second floor OPD Building UCMS and GTB Hospital Dilshad Garden Delhi
East
DELHI
110095
India |
| Phone |
9868575552 |
| Fax |
|
| Email |
tyagi_rishidoc@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya |
| Designation |
Postgraduate Resident |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Dentistry Second floor OPD Building UCMS and GTB Hospital Dilshad Garden Delhi
East
DELHI
110095
India |
| Phone |
9899389835 |
| Fax |
|
| Email |
dvsharmaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dentistry Second Floor OPD Building University College of Medical Sciences and GTB Hospital Dilshad Garden Delhi 110095 India |
|
|
Primary Sponsor
|
| Name |
Dr. Divya |
| Address |
University College of Medical Sciences and GTB Hospital Dilshad Garden Delhi 110095 |
| 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 Divya |
University College of Medical Sciences and GTB Hospital |
Department of Dentistry Second floor OPD Building University College of Medical Sciences and GTB Hospital Dilshad Garden
East
DELHI |
9899389835
dvsharmaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Research University College of Medical Sciences University of Delhi Delhi-110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hybrid resin polymer crowns |
Preformed crowns which are recently introduced are biocompatible flexible and with a snug fit on the tooth. Clinical evaluation and parental satisfaction will be assessed over a period of 12 months. |
| Comparator Agent |
Stainless steel crowns |
Presently the gold standard treatment for crowns are stainless steel crowns. They have excellent clinical performance, affordability and low technique sensitivity . They will be clinically evaluated and their parental satisfaction will be assessed over a period of 12 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Child with bilateral carious primary molars of same type in mandibular arch (first primary molars of both side or second primary molars of both side) indicated for crown.
Firm tooth with adequate support.
Each primary molar of the pair must have an antagonist tooth.
Primary teeth with at least two-thirds of the root length remaining.
Patient with behavioral rating of definitely positive or positive according to Frankl behavior. |
|
| ExclusionCriteria |
| Details |
Patient with allergy to local anaesthesia, nickel or chromium. Radiographic evidence of teeth with internal resorption and inter-radicular bone loss.
Children with bruxism or deep bite.
Tooth close to natural exfoliation.
Children with special health care needs.
Severely decayed primary molars making retention and the sealing of the restoration difficult.
Primary molars in infra occlusion. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare clinical outcomes and parental satisfaction (gingival health,plaque accumulation,marginal adaptation,retention TMJ problems wear of opposing teeth,shape size colour durability and overall satisfaction) |
Over a period of 1,3,6,9 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare clinical outcomes like gingival health, plaque accumulation, retention & parental satisfaction for size, shape, colour in stainless steel versus hybrid resin polymer crowns |
Over a period of 1,3,6,9 & 12 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| 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="1"
Months="10"
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
|
Recently introduced, Hybrid resin polymer crowns are flexible, adaptable and
durable in oral cavity. They are available as preformed crowns that offer properties of both SSC and
zirconia crowns. These crowns are biocompatible, flexible and with a snug fit on the tooth. There is a
scarcity of literature available on Hybrid resin polymer crowns comparing to the crowns traditionally
available. Therefore, the aim of this study is to clinically evaluate and compare SSC crowns and Hybrid
resin polymer crowns in primary molars. |