| CTRI Number |
CTRI/2024/07/069837 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
clinical evaluation of different adhesives in restoration of cervical lesions of teeth |
|
Scientific Title of Study
|
Clinical evaluation of HEMA free and HEMA containing universal adhesives in restoration of non-carious cervical lesions via etch-and-rinse and self-etch approach:18 months follow up |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Singh Bhambu |
| Designation |
Post graduate student |
| Affiliation |
JCD Dental College, Sirsa |
| Address |
room no-7
Department of Conservative Dentistry and Endodontics
JCD Dental college, Sirsa
Sirsa
HARYANA
125055
India |
| Phone |
7082603209 |
| Fax |
|
| Email |
bhambu.arpita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Singla |
| Designation |
Head of the Department |
| Affiliation |
JCD Dental College, Sirsa |
| Address |
Room no-7
Department of Conservative Dentistry and Endodontics
JCD Dental College, Sirsa
Sirsa
HARYANA
125055
India |
| Phone |
9466671007 |
| Fax |
|
| Email |
singlaendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Singh Bhambu |
| Designation |
Post graduate student |
| Affiliation |
JCD Dental College, Sirsa |
| Address |
Room no-7
Department of Conservative Dentistry and Endodontics
JCD Dental College, Sirsa
Sirsa
HARYANA
125055
India |
| Phone |
7082603209 |
| Fax |
|
| Email |
bhambu.arpita@gmail.com |
|
|
Source of Monetary or Material Support
|
| JCD Dental College, Barnala road, Sirsa (Haryana)India 125055 |
|
|
Primary Sponsor
|
| Name |
JCD Dental College Barnala road Sirsa Haryana |
| Address |
room no 7
Department of Conservative Dentistry and Endodontics
JCD Dental college Sirsa |
| 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 |
| Dr Arpita Singh Bhambu |
Jan nayak Ch. Devilal Dental college Sirsa |
room no 7
Department of Conservative Dentistry and Endodontics
JCD Dental college, Sirsa
Sirsa
HARYANA |
07082603209
bhambu.arpita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee JCD Dental College,Sirsa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Universal adhesives HEMA containing will be used for non-carious cervical lesions via self etch and etch and rinse approach |
96 non-carious cervical lesions will be restored and evaluated over baseline, 6,12 and 18 months |
| Comparator Agent |
Universal adhesives HEMA free will be used for non-carious cervical lesions via self etch and etch and rinse approach |
96 non-carious cervical lesions will be restored and evaluated over baseline,6,12 and 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non-carious cervical lesions in vital teeth
Patients to have atleast 20 teeth under occlusion. |
|
| ExclusionCriteria |
| Details |
Patients with poor oral hygiene.
Patients with pulpal involvement |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| functional esthetic and biological properties will be assessed in non-carious cervical lesions over 18 months |
using revised FDI criteria |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical evaluation of HEMA free & HEMA containing universal adhesives in restoration of NCCLs via etch & rinse & self-etch approach using Revised FDI criteria over a period of 18 months |
evaluation will be done at baseline 6 months 12 months & 18 months |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1" |
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 - NO
|
|
Brief Summary
|
Clinical evaluation of HEMA free and HEMA containing universal adhesives in restoration of non-carious cervical lesions via etch-and-rinse and self-etch approach - 18 months follow up Non-carious cervical lesions will be restored using 2 different types of universal adhesives (HEMA free and HEMA containing) followed by composite restoration via two different approaches i.e. etch-and-rinse and self-etch using revised FDI criteria. Esthetic, functional and biological properties will be evaluated at baseline,6,12 and 18 months. |