| CTRI Number |
CTRI/2024/06/068868 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
to compare the clinical success of using two different types of glass ionomer cements used to give crowns in children
|
|
Scientific Title of Study
|
Clinical comparison of various luting options for strip crowns in primary anterior teeth |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
balaji suresh |
| Designation |
post graduate student |
| Affiliation |
Saveetha Dental College And Hospitals |
| Address |
Department of pediatric dentistry,
room no-28,
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9952207281 |
| Fax |
|
| Email |
balajimahadevan18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
balaji suresh |
| Designation |
post graduate student |
| Affiliation |
Saveetha dental college and Hospitals |
| Address |
Department of pediatric dentistry,
room no-28
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9952207281 |
| Fax |
|
| Email |
balajimahadevan18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
balaji suresh |
| Designation |
post graduate student |
| Affiliation |
Saveetha dental college And Hospitals |
| Address |
Department of pediatric dentistry,
room no 28,
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9952207281 |
| Fax |
|
| Email |
balajimahadevan18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College And Hospitals |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrMaria |
saveetha dental college |
Department of pediatric dentistry,
room no-28,
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
97899986578
mariaanthonetsruthi.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College Institutional Human Ethical Committee-( |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
composite cements |
tooth coloured fillings materials |
| Intervention |
type 2 and 9 glass isomer cement |
it is permanent restorative cements used in dental fillings
evaluated for 3 months, 6months, 9 months, 12 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 to 5 years who required pulpectomy in contralateral primary maxillary central and lateral incisors in the same patient were recruited.
Children diagnosed with early childhood caries (ECC) for whom all the procedures are planned to be performed under general anesthesia .
Children belonging to ASA classification 1
Teeth with proximal decay or fracture .
Radiographically teeth having 2/3rd of root and at least 1/3rd of the crown
|
|
| ExclusionCriteria |
| Details |
Children exhibiting any deleterious oral habit
Mobile teeth
Hypoplastic teeth
Presence of sinus tract or abscess
Radiographic presence of root resorption of more than 1/3rd of the root.
Radiographic identification of root fracture
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical sucess of the crown |
clinical sucess of the crown at 3months, 6months, 9 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 2 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="6"
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 - 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
- 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 [balajimahadevan18@gmail.com].
- For how long will this data be available start date provided 03-06-2024 and end date provided 05-03-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The pilot trial was conducted on 12 patients, all of them who had their primary upper, right and left, central and lateral incisor affected . The number of teeth included in the study were 48 and were subdivided into three groups based on the material with which they were restored : Group 1(control)- Composite(n=16) , group 2 -Type II GIC (n=16) and group 3-Type IX GIC (n=16) . The clinical success of these crowns were assessed using the modified (United States Public Health Services) USPHS criteria which involved evaluation of seven different parameters that emphasized on the aesthetic, biologic and functional standards of the crowns used . The crowns were screened at four different time points : 3 months, 6 months, 9 months and 12 months. Statistical analysis was performed using the Chi-square test .
|