| CTRI Number |
CTRI/2024/12/077653 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of different crowns in teeth. |
|
Scientific Title of Study
|
Comparative evaluation of child-parental satisfaction and radiographic analysis of Bioflex, Zirconia and Stainless steel crowns in pediatric patients. |
| 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 Namrata Ingavale |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College, Raipur. |
| Address |
Department of Pediatric and Preventive Dentistry , Room No. 11 , Government Dental College , Raipur.
Raipur CHHATTISGARH 492001 India |
| Phone |
9743227618 |
| Fax |
|
| Email |
namratani8399@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunil Pandey |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College, Raipur. |
| Address |
Department of Pediatric and Preventive dentistry, Room No. 11 , Government Dental College, Raipur.
Raipur CHHATTISGARH 492001 India |
| Phone |
9993912218 |
| Fax |
|
| Email |
drsunilpandeymds@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Namrata Ingavale |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College, Raipur. |
| Address |
Department of Pediatric and preventive Dentistry , Room No. 11 , Government Dental College , Raipur.
Raipur CHHATTISGARH 492001 India |
| Phone |
9743227618 |
| Fax |
|
| Email |
namratani8399@gmail.com |
|
|
Source of Monetary or Material Support
|
| Namrata Ingavale, Post graduate Student , Department of Pediatric and Preventive Dentistry , Government Dental College Raipur, Chhattisgarh , India , Pin NO. - 492001 |
|
|
Primary Sponsor
|
| Name |
Dr Namrata Ingavale |
| Address |
Department of Pediatric and Preventive Dentistry, Government Dental College, Raipur (C.G.) Pin NO. 492001 |
| 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 Namrata Ingavale |
Government Dental College |
Department of Pediatric and Preventive Dentistry , Government Dental College, Rajbandha , Maidan Path, Near Marhi Mata Mandir , Raipur Raipur CHHATTISGARH |
9743227618
namratani8399@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Teeth with irreversible pulpitis requiring crown prosthesis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bioflex Crowns, Zirconia Crowns |
Prosthesis after pulpectomy and/or Pulpotomy |
| Comparator Agent |
Stainless Steel Crowns |
Prosthesis after pulpectomy and/or Pulpotomy |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients within the age group of 5-10 years.
2.Healthy children free of any systemic disease.
3.Deciduous teeth having two-thirds of root structure left radiographically.
4.Presence of one-third of crown shape.
5.Children free of any developmental disturbances of the teeth.
6.Asymptomatic primary molars following pulp therapy indicated for full coverage restoration.
7.Patients with good oral hygiene.
8.Children with signed consent form by the parent or guardian after being informed about the various benefits, risks and treatment outcomes.
|
|
| ExclusionCriteria |
| Details |
1.Teeth exhibiting Pre-shedding mobility.
2.Children with parafunctional habits.
3.A pathological discrepancy of root resorption.
4.Inflammation at the furcation area.
5.Deciduous teeth having not sufficient crown structure.
6.Teeth with root caries.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will help us to know which crown among the Bioflex , Zirconia and Stainless steel is better in terms of Clinical(GI & PI) , Radiographic (marginal adaptation) and child-parental satisfaction(MCDAS & likert scale). |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best effective crown material among Bioflex , Zirconia and Stainless Steel is been evaluated , which will be helpful in future restorative treatments in Pediatric patients. |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
30/12/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [namratani8399@gmail.com].
- For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
54 samples will be collected and divided into
Three groups each of n=18 namely :-
1.
Group 1 – Patients with Bioflex
Crowns as restoration.
2.
Group 2 - Patients with Zirconia
Crowns as restoration.
3.
Group 3 - Patients with Stainless
Steel Crowns as restoration.
54 Patients will be selected
based on the Inclusion and Exclusion Criteria. Complete process of what process
will going to perform on the tooth of the child will be explained to the
Parents/The person accompanying the patient. All the procedures will going to
be performed under rubber dam isolation. The Radiovisiography(RVG) radiographs
will be taken. The crown to be prepared and patients will be divided into
selected groups. The placement of Bioflex, Zirconia and Stainless Steel Crowns
will be done. All the crowns will be placed by a single operator.
Local anesthesia will be
administered and rubber dam will be placed. The manufacturer’s guidelines will
be followed to develop a step by step customized tooth preparation to ensure
all crowns were fitted in a similar manner. All crowns will be luted using type
I Glass Ionomer Cement. The type and size of crown chosen as well any adaption
methods done for each molar were recorded. Patients will be given postoperative
instructions. Participants will recalled for follow up at 3 months, 6 months,
12 months. Variables for the clinicians satisfaction will be scored using a
customized scoring table which was modified from similar previous studies.
Immediate post cementation
radiograph will be taken for baseline measurements. Patient will then be
recalled after 3, 6 and 12 months. The recalled patients will be checked for “plaque
accumulation and gingival health†by using Plaque Index and Gingival Index,
respectively. And the “Marginal Adaptation†will be checked by using Radiovisiography(RVG).
Child satisfaction is
determined using Modified Child Dental Anxiety Scale(MCDAS). Parental
satisfaction was assessed on a Likert type scale from 1 to 5. The questionnaire
will be given to parents. Parents will asked to return the questionnaire on
completion. Scores 1 and 2 were combined as satisfied, score 3 as neutral
response and scores 4 and 5 were combined as dissatisfied. Scoring of parental
and child satisfaction will be taken at 3 months, 6 months, 12 months .Then the
respective outcomes will be compared. |