| CTRI Number |
CTRI/2024/02/062937 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate four parameters between two composite restorative materials. |
|
Scientific Title of Study
|
Comparative Evaluation of Short Fiber-Reinforced Composite and Bulk fill Resin Composite Restoration in Primary Posterior Teeth: An in Vivo Study |
| Trial Acronym |
IRB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabha Shree |
| Designation |
Student |
| Affiliation |
THE OXFORD DENTAL COLLEGE BANGALORE INDIA |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College, Hongasandra, Bommannahalli Bangalore
Bangalore KARNATAKA 560068 India |
| Phone |
08210507983 |
| Fax |
|
| Email |
dr.prabhashree06@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bharath Vardhana S |
| Designation |
Reader |
| Affiliation |
THE OXFORD DENTAL COLLEGE BANGALORE INDIA |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College, Hongasandra, Bommannahalli Bangalore
Bangalore KARNATAKA 560068 India |
| Phone |
9886588595 |
| Fax |
|
| Email |
bharathdentist@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prabha Shree |
| Designation |
Student |
| Affiliation |
THE OXFORD DENTAL COLLEGE BANGALORE INDIA |
| Address |
Department of Pediatric and Preventive Dentistry
The Oxford Dental College, Hongasandra, Bommannahalli Bangalore
Bangalore KARNATAKA 560068 India |
| Phone |
08210507983 |
| Fax |
|
| Email |
dr.prabhashree06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry
The Oxford Dental College, Hongasandra, Bommannahalli Bangalore, Karnataka 560068 |
|
|
Primary Sponsor
|
| Name |
Dr Prabha Shree |
| Address |
S-13 , 2nd floor , Prabhavathi plasma Apt, 28 Ramayana lyt, 7th main 6th cross , Garvebhavi Palya , BANGALORE |
| 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 Prabha Shree |
The oxford dental college |
4 th floor, Room number-8 , Department of Pediatric and Preventive Dentistry, Hongasandra,Bommannahalli Bangalore KARNATAKA |
08210507983
dr.prabhashree06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE The oxford dental college, Bommanahalli Hosur Road Bangalore 560068 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLASS I OCCLUSAL CARIES CAVITY PREPARATION AND COMPOSITE RESTORATION GROUP I- EVER X FLOW GROUP II- TETRIC N CERAM |
Clinical evaluation between GROUP I- EVER X FLOW (GC JAPAN TOKYO) GROUP II- TETRIC N CERAM (IVOCLAR VIVADENT SCHAAN LIECHTENSTEIN)
Total Duration : 30 min |
| Intervention |
Clinical evaluation |
To evaluate the marginal adaptation of the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite.
To assess the post-operative sensitivity of the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite.
To evaluate the development of secondary caries in the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite.
To assess the surface texture of the teeth restored by the short fiber-reinforced composite and bulk-fill resin composite.
[Modified United States Public Health Services (USPHS) Criteria]
Total Duration : 30 min
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Cooperative children.
2.Vital primary molars.
3.Patients with a good likelihood of recall availability.
4.Teeth without any symptoms.
5.Class I cavities only (occlusal surface).
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised children.
2. Extensive carious lesions.
3. Suspected of any drug or restorative material allergy.
4. Potential behavioral disorders.
5. Radiographic indication of pulp involvement
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be clinically evaluated under the USPHS criteria (marginal adapatation post operative sensitivity surface texture secondary caries) by comparing the restorations done on the class I cavity between group I - Ever X Flow composite and group II-Tetric N Ceram composite |
3 months & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will compare the good clinical performance between two composites materials suitable for restoring the primary molars |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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)
|
01/03/2024 |
| 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)
|
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
|
Direct restorations have been largely employed to restore posterior teeth due to their low cost when compared to indirect restorations, along with acceptable clinical performance. Resin composite restorations in the high stress-bearing area led to some common failures that are secondary caries, marginal leakage, and post-operative sensitivity. To overcome the weakness of the resin composites manufacturers developed short fiber-reinforced composites (SFRC). They are dentine replacing material in posterior high stress-bearing restorations, especially molars. The material also revealed control in polymerization shrinkage stress by fiber orientation reducing the microleakage compared with that of the composites. The resin matrix contains inorganic particulate fillers and short glass fibers that provide three-directional reinforcement. Since most of the studies have focused on evaluating SFRC in permanent teeth, there are very few studies done on primary teeth. Thus, this study aims to evaluate the clinical performance (marginal adaptation, postoperative sensitivity, development of secondary caries, and surface texture) of composite restorations restored by short fiber-reinforced composite and bulk-fill resin composite. |