| CTRI Number |
CTRI/2024/05/068153 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study comparing bond strength between biodentine to composite resin with different bonding agents in human teeth |
|
Scientific Title of Study
|
Evaluation of Shear Bond Strength and Mode of Fracture Between Biodentine to Composite Resin using Various Bonding Agents: An Observational 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 Harish Harlalka |
| Designation |
PG 1st year |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
room no-124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, BIU,Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8804611587 |
| Fax |
|
| Email |
harishharlalka13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Vijay Singh |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
room no-124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, BIU,Bareilly
Bareilly
UTTAR PRADESH
243301
India |
| Phone |
8979046787 |
| Fax |
|
| Email |
drcvs3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandra Vijay Singh |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences, Bareilly |
| Address |
room no-124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, BIU,Bareilly
Bareilly
UTTAR PRADESH
243301
India |
| Phone |
8979046787 |
| Fax |
|
| Email |
drcvs3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no-124, Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, BIU,Bareilly
UTTAR PRADESH
243006
India |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Sciences, Bareilly |
| Address |
Pilibhit Bypass Rd, opposite to Suresh Sharma Nagar, Chandpur Bichpuri, Bareilly, Uttar Pradesh 243006 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Harish Harlalka |
Institute of Dental Sciences,Bareilly |
Room no-124, Department of Conservative Dentistry and Endodontics, institute of Dental sciences, Pilibhit Bypass Rd, opposite to Suresh Sharma Nagar, Bareilly, Uttar Pradesh,243006
Bareilly
UTTAR PRADESH |
0581-2526244
harishharlalka13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IDS,Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z049||Encounter for examination and observation for unspecified reason, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
7th generation Bonding Agent |
bonding agent between biodentine and composite for fifty two weeks. |
| Comparator Agent |
Hema containing universal bonding agent |
Bonding agent Between Biodentine to Composite for fifty two weeks |
| Comparator Agent |
Hema Free universal bonding agent |
Bonding agent between biodentine and composite for fifty two weeks. |
| Intervention |
No Adhesive |
placebo for fifty two weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Extracted Single Rooted Premolar in toto. Teeth with closed apex.
|
|
| ExclusionCriteria |
| Details |
Teeth with caries, restoration, or any developmental disturbances. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bond Strength |
Fifty two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| type of fracture between biodentine & composite |
Fifty two weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/06/2024 |
| 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="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 - 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 - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [harishharlalka13@gmail.com].
- For how long will this data be available start date provided 25-12-2026 and end date provided 25-12-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The main aim of any
restorative treatment is to promote remineralisation of affected dentin and to
build up healthy dental tissues while also limiting the microbial invasion
within tooth structure. Adhesive compounds
consist of monomers that are both hydrophilic and hydrophobic in nature. The
chemical composition of the adhesive’s monomers and solvents is what
distinguishes hydrophobic adhesives from hydrophilic ones. 2-Hydroxyethyl Methacrylate (HEMA) is a widely used hydrophilic monomer in
self-etch adhesive systems. It easily mixes with
water and works well as a wetting agent for dental adhesives during
polymerization. Its low molecular weight helps it spread efficiently within
dentin for better penetration. However, adhesives containing HEMA are
vulnerable to hydrolytic degradation because they absorb water at higher rates To date, limited studies have compared the bonding capabilities of Biodentine to composite using 7th generation, and universal bonding agents at two setting periods. Therefore, the objective of this study will be to measure the shear bond strength (SBS) values of Biodentine to composite using various bonding agents and identify the fracture modes exhibited by the specimens. |