| CTRI Number |
CTRI/2021/08/035494 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
23/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparisons of different filling materials in Non carious cervical Lesion . |
|
Scientific Title of Study
|
Comparative Evaluation of Clinical Efficacy of Different Restorative Materials in Class V Lesions: An In Vivo Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanu |
| Designation |
Post Graduate Student |
| Affiliation |
Sgt Dental College |
| Address |
Department of Conservative Dentistry and Endodontics , Faculty of Dental Sciences , Sgt Dental College ,Sgt University
Gurgaon - Badli Road Chandu ,Budhera, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9812450721 |
| Fax |
|
| Email |
ushayadav9416@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Singla |
| Designation |
Reader |
| Affiliation |
Sgt Dental College , Gurugram |
| Address |
Department of Conservative Dentistry and Endodontics , Faculty of Dental Sciences , Sgt Dental College ,Sgt University
Chandu-Budhera , Gurgaon-Badli Road, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9205713304 |
| Fax |
|
| Email |
mamta.singla@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanu |
| Designation |
Post Graduate Student |
| Affiliation |
Sgt Dental College , Gurugram |
| Address |
Department of Conservative Dentistry and Endodontics , Faculty of Dental Sciences , Sgt Dental College ,Sgt University, Budhera , Gurugram
Chandu-Budhera , Gurgaon-Badli road, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9812450721 |
| Fax |
|
| Email |
ushayadav9416@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics , Faculty of Dental Sciences ,Sgt Dental College , Sgt University ,Gurgaon , Haryana |
|
|
Primary Sponsor
|
| Name |
Dr Tanu |
| Address |
Sgt Dental College,Department of Conservative Dentistry and Endodontics , Faculty of Dental Sciences ,Budhera , Gururgram |
| 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 Tanu |
Sgt Dental College |
Department of Conservative Dentistry and Endodontics , Faculty of Dental Sciences , Sgt Dental College , Sgt University , Budhera , Gurugram
Gurgaon
HARYANA |
9812450721
ushayadav9416@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Carious Class V Cervical Lesions |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Composite and Cention N is used . |
The dentist will use Composite and Cention N for Non carious cervical lesions. The followup will be done at 3 ,6,9 months and 1year. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
Subjects with fair oral hygiene
Saucer shaped or V shaped cervical lesions
Maxillary and mandibular canine and posterior teeth
Vital teeth
Teeth with occlusion and inter proximal contact
Subjects with age between 18–75 years
|
|
| ExclusionCriteria |
| Details |
Carious cervical lesions |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Evaluate and Compare Clinical Efficacy Of Newer Alkasite Material and Composite using USPHS Criteria
Â
|
Assessed at 3,6,9 months and 1 year
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|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/08/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Purpose of this study is Comparative evaluation of clinical efficacy of cention N and composite in non carious class V Cervical lesions . The sample size of this trial is 300 which is divided into two groups of 150 each . The followup will be done at 3, 6, 9 months and 1 year using USPHS Criteria . |