| CTRI Number |
CTRI/2023/07/055808 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of different crowns used in pediatric dentistry with the help of cliniical and radiographic parameters . |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiographic efficacy of bioflex crowns, preformed zirconia crowns and stainless steelcrowns in primary second molars – a randomized controlled clinical trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saakshi Goel |
| Designation |
Post graduate student |
| Affiliation |
I.T.S Dental College |
| Address |
Department of Pediatric and Preventive dentistry , room number 7 , 2nd Floor
I.T.S Dental College , NH 34 , Delhi Meerut Road , Muradnagar , Ghaziabad , Uttar Pradesh - 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9810170764 |
| Fax |
|
| Email |
SaakshiGoel_MDS21_24@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Mathur |
| Designation |
Professor and Head of Department |
| Affiliation |
I.T.S Dental College |
| Address |
Department of Pediatric and Preventive Dentistry , room number 7 , 2nd Floor
I.T.S Dental College , NH 34 , Delhi Meerut Road , Muradnagar , Ghaziabad , Uttar Pradesh - 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8826221676 |
| Fax |
|
| Email |
shivanimathur.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saakshi Goel |
| Designation |
Post graduate student |
| Affiliation |
I.T.S Dental College |
| Address |
Department of Pediatric and Preventive Dentistry , room number 7 , 2nd floor
I.T.S Dental College , NH 34 , Delhi Meerut Road , Muradnagar , Ghaziabad , Uttar Pradesh - 201206
UTTAR PRADESH
201206
India |
| Phone |
9810170764 |
| Fax |
|
| Email |
SaakshiGoel_MDS21_24@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive dentistry , room number 7 , 2nd floor , I.T.S Dental college , NH 34 , Delhi Meerut Road , Muradnagar , Ghaziabad , Uttar Pradesh - 201206 |
|
|
Primary Sponsor
|
| Name |
DR SAAKSHI GOEL |
| Address |
I.T.S DENTAL COLLEGE
DELHI MEERUT ROAD , NH-34 , MURADNAGAR , GHAZIABAD
UTTARPRADESH 201206 |
| 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 Saakshi Goel |
ITS-CDSR |
Department of pesiatric and Preventive dentistry (Room number 7 , 2nd Floor)
its dental college , nh - 34 , delhi meerut road , muradnagar , ghaziabad , uttar pradesh - 201206
Ghaziabad
UTTAR PRADESH |
9810170764
SaakshiGoel_MDS21_24@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy Individuals |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Zirconia Crowns |
Different Crowns in Pediatric Dentistry - Bioflex Crowns , Preformed Zirconia Crowns , Stainless steel crowns and follow up at baseline 15 days , 3 months and 6 months for oral hygiene , gingival margins and bite force . |
| Intervention |
Bioflex crowns |
follow up at baseline 15 days , 3 months and 6 months for oral hygiene , gingival margins and bite force |
| Intervention |
Stainless Steel crowns |
follow up at baseline 15 days , 3 months and 6 months for oral hygiene , gingival margins and bite force |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient in the age group of 4-8years having primary molars indicated for full coverage restoration.
2. Frankl’s behavior rating scale 3 and 4 will be taken.
3. Children for whom consent will be obtained.
|
|
| ExclusionCriteria |
| Details |
1.Systemic disease.
2. Allergic to any drug such as LA, nickel and or a resin restorative material.
3. Extremely poor oral hygiene.
4. Malocclusion.
5. Child with parafunctional habits
6. Child with special needs.
7. Class 1, 2 & 3 mobility according to the Millers classification.
|
|
|
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 |
clinical application of Bioflex crowns as an alternative for Preformed Zirconia crown and SSC
The choice of the crowns during treatment plan can be made specific to each child based on the demands of the parents and the clinical scenario.
|
15 Days , 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The clinical and radiographic efficacy along with parent satisfaction of Bioflex crowns will be comparable to Pre formed zirconia crowns and stainless steel crowns.
|
15 Days , 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
07/08/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: To compare the clinical
performance , survival rate , oral hygiene , treatment time and parental
satisfaction of high impact composite resin crowns in primary molars .
OBJECTIVES :
1. To
compare the oral hygiene and gingival health of high impact composite resin
crowns , composite , zirconia crown and
SSC by using the
simplified Oral Hygiene Index (OHI-S), Gingival Index (GI), Plaque Index (PI)
over a period of 6 months .
2. To
compare the occlusion and bite force before and after the placement of these
crowns.
3. Evaluation
of tooth wear of opposing tooth using Smith and Knight Index .
4. Compare
survival rate , color change and Retention ( clinical performance ) of the
given crowns .
5. Comparison
of patient satisfaction in all four groups (GROUPS A, B , C, ) .
|