| CTRI Number |
CTRI/2024/06/069027 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [fiber reinforced composite material ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Types of Reinforced Filling Materials for Severely Damaged Back Teeth: A One-Year Study |
|
Scientific Title of Study
|
One year comparative evaluation of performance of short glass fiber reinforced composite resin versus combination of short glass fiber with polyethylene fiber reinforced composite resin on badly broken-down vital posterior tooth: a randomized clinical study. |
| 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 Ruchi Kumar Purbey |
| Designation |
PG student |
| Affiliation |
K M Shah Dental College And Hospital |
| Address |
Department of conservative dentistry and endodontics
K M Shah Dental College And Hospital
Sumandeep Vidhyapeeth University Waghodia Road, Piparia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9755975516 |
| Fax |
|
| Email |
ruchikumar2507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Head Of the Department |
| Affiliation |
K M Shah Dental College And Hospital |
| Address |
Department of conservative dentistry and endodontics
K M Shah Dental College And Hospital
Sumandeep Vidhyapeeth University Waghodia Road, Piparia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Head Of the Department |
| Affiliation |
K M Shah Dental College And Hospital |
| Address |
Department of conservative dentistry and endodontics
K M Shah Dental College And Hospital
Sumandeep Vidhyapeeth University Waghodia Road, Piparia, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics
K. M. Shah Dental College and Hospital
Sumandeep vidyapeeth university Waghodia, Dist, Vadodara, Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Ruchi Kumar Purbey |
| Address |
Department of conservative dentistry
K. M. Shah Dental College and Hospital, Sumandeep Vidhyapeeth University Waghodia Road, Piparia, Vadodara, Gujarat 391760 |
| 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 Ruchi Kumar Purbey |
K. M. Shah Dental College and Hospital |
Department of conservative dentistry
K. M. Shah Dental College and Hospital, Sumandeep Vidhyapeeth University Waghodia Road, Piparia, Vadodara, Gujarat 391760
Vadodara
GUJARAT |
9755975516
ruchikumar2507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidhyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
combination of short glass fiber everx flow with polyethylene fiber reinforced composite resin |
everx flow material is composed of short, randomly oriented glass fibers of length 140µm and the average diameter is 6µm in a Bis-GMA, TEGDMA resin matrix
Ribbond is a Leno weaved ultra-high-molecular-weight polyethylene fiber that undergoes surface treatment to enable bonding with resin materials |
| Comparator Agent |
short glass fiber reinforced composite resin everx flow |
everx flow material is composed of short, randomly oriented glass fibers of length 140µm and the average diameter is 6µm in a Bis-GMA, TEGDMA resin matrix |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 18 – 60 years of age with moderate to enlarge carious lesions involving one or more cusps in vital molars and premolars with clinical diagnosis of reversible pulpitis will be included in the study.26
2. Teeth with radiographic findings revealing radiolucency in coronal dentin with presence of hard dentin between base of the caries and pulp horn on RVG will be included.27
3. Teeth indicated for re-restoration will be included.
4. Teeth with intact and healthy adjacent and opposing tooth will be included.
5. A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with poor oral hygiene, severe periodontal disease, mal-aligned and heavy bruxism resulting in lost physiologic contour will be excluded.
2. Tooth indicated as an abutment for fixed partial denture and tooth having more than grade 1 mobility will be excluded.
3. Teeth with developmental anomaly or pathology or congenital defects will be excluded.
4. Patients with Non restorable subgingival caries/ fracture will be excluded.
5. Patients with occlusal discrepancies will be excluded.
6. Pregnant and lactating mothers will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically evaluate and compare the functional, biological and aesthetic properties of using short glass fiber reinforced composite resin versus combination of short glass fiber with polyethylene fiber reinforced composite resin based on Revised FDI criteria to evaluate direct dental restorations at 6 and 12 months on badly broken-down vital posterior teeth. |
baseline 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
One year comparative evaluation of performance of short glass fiber reinforced composite resin versus combination of short glass fiber with polyethylene fiber reinforced composite resin based on Revised FDI criteria to evaluate direct dental restorations at 6 and 12 months on badly broken-down vital posterior teeth: a randomized clinical study. Results of the study will help us to know that which material clinically performs better between Ever-X Flow composite and combination of Ever-X Flow with Ribbond as restorative material and would replace the conventional cast restoration through a more conservative approach which will provide potential benefit to the patients as well as clinicians in terms of reducing the number of appointments, chair side time & cost. |