| CTRI Number |
CTRI/2021/11/038198 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
18/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post-operative sensitivity in non carious cervical lesions using Universal adhesives |
|
Scientific Title of Study
|
Evaluation of post-operative sensitivity in non carious cervical lesions using two Universal adhesives in different adhesive strategies - A Double-blinded Randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krisha Doshi |
| Designation |
PG student |
| Affiliation |
Saveetha Dental COllege and Hospitals, Chennai |
| Address |
Departmetn of Conservative Dentistry and Endodontics,
Saveetha Dental College and Hospitals,
Velapanchavadi,
Poonamallee High Road,
Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9108858350 |
| Fax |
|
| Email |
doshikrisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nivedhitha MS |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental COllege and Hospitals, Chennai |
| Address |
Departmetn of Conservative Dentistry and Endodontics,
Saveetha Dental College and Hospitals,
Velapanchavadi,
Poonamallee High Road,
Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840912367 |
| Fax |
|
| Email |
nivedhitha@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krisha Doshi |
| Designation |
PG student |
| Affiliation |
Saveetha Dental COllege and Hospitals, Chennai |
| Address |
Departmetn of Conservative Dentistry and Endodontics,
Saveetha Dental College and Hospitals,
Velapanchavadi,
Poonamallee High Road,
Chennai.
TAMIL NADU
600077
India |
| Phone |
9108858350 |
| Fax |
|
| Email |
doshikrisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals, Chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Department of Cnservative Dentistry and Endodontics
Saveetha Dental COllege and Hospitals
Valapanchavadi
Poonamallee High Road
Chennai |
| 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 Krisha Doshi |
Saveetha Dental College and Hospitals Chennai |
Department of Cnservative Dentistry and Endodontics
Saveetha Dental COllege and Hospitals
Valapanchavadi
Poonamallee High Road
Chennai
Thiruvallur
TAMIL NADU |
9108858350
doshikrisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee, Saveetha Dental College and Hospitals Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, (2) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Universal adhesives in Self-etch adhesive strategy |
Use of self-etch adhesive strategy using two Universal ahesives namely Singlebond Universal (3M ESPE) and Prime and Bond Universal (Dentsply) |
| Comparator Agent |
Universal Adhesives in total-etch adhesive strategy |
Use of total-etch adhesive strategy using two Universal adhesives namely Singlebond Universal (3M ESPE) and Prime and Bond Universal (Dentsply) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients 30-50 years of age
atleast 2 NCCLs in each quadrant
depth of the lesion 1-3mm,
presence of antagonist teeth. |
|
| ExclusionCriteria |
| Details |
poor gingival and periodontal health; uncontrolled rampant caries; bruxism; patients with systemic diseases. |
|
|
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 |
| Reduced VAS score for assessment of postoperative sensitivity at 24 hrs, 1week, 2weeks, 4 weeks. |
24 hrs, 1week, 2weeks, 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-operative sensitivity
is one of the main complications occurring after placing composite
restorations. Although there may be numerous reasons for its occurrence,
adhesives play an important role. The introduction of Universal adhesives, has significantly eased the process of
adhesion for the clinician since the same adhesive can be used in various
strategies of adhesion (total etch, self etch, selective etch). But the use of
different adhesive strategies may cause post-operative sensitivity. This study
will help understand the effect of adhesive strategy used on the post-operative
sensitivity |