| CTRI Number |
CTRI/2019/08/020634 [Registered on: 08/08/2019] Trial Registered Prospectively |
| Last Modified On: |
07/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Non carious Cervical lesions Extending to Root |
|
Scientific Title of Study
|
Evaluation of adhesion strategies in restoration of Non Carious Cervical Lesions extending to root surface-a randomized controlled trial |
| Trial Acronym |
ADHNCCL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Praveen |
| Designation |
Post graduate student |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Room no 9, Department of conservative dentistry and Endodontics, Meenakshi Academy of Higher Education and Research, Meenakshi Ammal
dental college, no 1 Alapakkam main road, Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9095951837 |
| Fax |
|
| Email |
rpraveen1094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suma Ballal |
| Designation |
Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Room no 9 Department of conservative dentistry and Endodontics,Meenakshi Academy of Higher Education and Research, Meenakshi Ammal
dental college, no 1 Alapakkam main road, Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9444904706 |
| Fax |
|
| Email |
drsumarao69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Velmurugan |
| Designation |
Professor & Head |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Room no 9, Department of conservative dentistry and Endodontics,Meenakshi Academy of Higher Education and Research, Meenakshi Ammal
dental college, no 1 Alapakkam main road, Maduravoyal
Chennai
TAMIL NADU
600095
India |
| Phone |
9840164167 |
| Fax |
|
| Email |
vel9911@yahoo.com |
|
|
Source of Monetary or Material Support
|
| self funding - no outside source |
|
|
Primary Sponsor
|
| Name |
R Praveen |
| Address |
Room no 9 Department of conservative dentistry and Endodontics,Meenakshi Academy of Higher Education and Research, Meenakshi Ammal
dental college, no 1 Allapakam main road Maduravoyal
Chennai-60095
Tamil Nadu |
| Type of Sponsor |
Other [self funded, Meenakshi Ammal Dental College Allapakkam main road maduravoyal chennai 600095 ] |
|
|
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 |
| R Praveen |
Meenakshi Ammal Dental College |
Room no 9 Department of conservative dentistry and Endodontics,Meenakshi Academy of Higher Education and Research, Meenakshi Ammal
dental college, No 1 Alapakkam main road Maduravoyal
Chennai
TAMIL NADU |
9095951837
rpraveen1094@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHER institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Carious Cervical Tooth Lesion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TOTAL ETCH ADHESIVE(ETCH and RINSE) |
5th generation adhesive
will be applied and evaluated for 18 months |
| Intervention |
UNIVERSAL ADHESIVE |
8th Generation Adhesive will be applied and evaluated for 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with Non Carious Cervical Lesions extending to the root
Depth of non carious cervical lesion should be more than 1 mm |
|
| ExclusionCriteria |
| Details |
History of existing tooth hypersensitivity
Bruxism
Cervical Caries
Non-vital teeth
Known inability to return for recall Appointments
Fractured or visible cracked teeth
Medically compromised patients
Allergy to components of resin-based materials
Existing periodontal disease
Third molar
Sub gingival lesion
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Clinical performance between two universal adhesive agents using USPHS criteria |
1,3,6,12 and 18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulpal and Periodontal Health at the end of follow up periods. |
1,3,6,12 and 18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/08/2019 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be published after completing the trail |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to evaluate the clinical performances of two adhesive agents. The patients will be randomized to the following groups by simple randomization.GROUP 1: Total Etch (Etch and rinse - 5th Generation), GROUP 2: Universal Adhesive in Self Etch(8th Generation), GROUP 3: Universal Adhesive in Selective Enamel Etch(8th Generation), all the Restorative procedure will be carried out by a single operator. Adhesive protocol will be followed as per the randomization schedule. Restoration will be done using Nano Hybrid Composite. The patient and outcome assessor will be blinded to the study, making it a double-blinded randomized controlled trial. The patient will be evaluated by two independent calibrated examiners at time intervals of 1, 3, 6, 12 and 18 months using USPHS criteria. |