| CTRI Number |
CTRI/2023/08/056920 [Registered on: 25/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Renewal of root canal treated molar teeth |
|
Scientific Title of Study
|
Rehabilitation of Endodontically Treated Posterior Teeth With Minimal Invasive Approach- A Clinical Prospective 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 Vaishali Moryani |
| Designation |
Post Graduate |
| Affiliation |
Mahatma Gandhi Dental College and Hospital |
| Address |
Mahatma Gandhi Dental College and Hospital, Department of conservative dentistry and endodontics, First floor room no 5
Mahatma Gandhi Dental College and Hospital, Department of conservative dentistry and endodontics, First floor room no 5
Jaipur
RAJASTHAN
302022
India |
| Phone |
7976490653 |
| Fax |
|
| Email |
vaishalimoryani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Biderkatte |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Dental College and Hospital |
| Address |
Mahatma Gandhi Dental College and Hospital, Department of conservative dentistry and endodontics, First floor room no 5
Mahatma Gandhi Dental College and Hospital, Department of conservative dentistry and endodontics, First floor room no 5
Jaipur
RAJASTHAN
302022
India |
| Phone |
9654458794 |
| Fax |
|
| Email |
drashwini@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Biderkatte |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Dental College and Hospital |
| Address |
Mahatma Gandhi Dental College and Hospital, Department of conservative dentistry and endodontics, First floor room no 5
Mahatma Gandhi Dental College and Hospital, Department of conservative dentistry and endodontics, First floor room no 5
Jaipur
RAJASTHAN
302022
India |
| Phone |
9654458794 |
| Fax |
|
| Email |
drashwini@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Dental college and Hospital. |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Dental college and Hospital. |
| Address |
Mahatma Gandhi Dental college and Hospital, sitapura, jaipur 203022 |
| Type of Sponsor |
Other [MAHTMA GANDHI DENTAL COLLEGE AND HOSPITAL ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF |
plot no 194 1st C Road Sardarpura Jodhpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali Moryani |
Mahatma Gandhi Dental College and Hospital |
Mahatma Gandhi Dental College and Hospital, sitapura, jaipur 302022, Department of conservative dentistry and endodontics, First floor room no 5
Jaipur
RAJASTHAN |
7976490653
vaishalimoryani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC for Biomedical and Health Research as per National Ethics Committee Registry for Biomedical and Health Research ( NECRBHR) Provisional registration with number EC/NEW/INST/2020/1458 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
deep dental caries at different levels of destruction of tooth structure |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Natural Posterior teeth. |
Is the interventional tooth is simulating the natural tooth in functional, form and esthetics. |
| Intervention |
Rehabilitation of Endodontically Treated Posterior Teeth |
Rehabilitation of Endodontically Treated Posterior Teeth using direct composite restoration, ceramic inlay, onlay, endocrowns and fiber-reinforced post. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Asymptomatic root canal treated teeth
2 Teeth with complete root formation
3 Teeth without anatomic variations
4 Teeth with patent canals
|
|
| ExclusionCriteria |
| Details |
1 Teeth with open apices
2 Parafunction habit
3 Lateral occlusal forces
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preservation of peri cervical dentine for strengthen the posterior tooth |
In duration of 1,3,6,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| minimal invasive approach for rehabilitation of endodontically treated tooth |
in duration of 1,3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/09/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Conventional methods of restoring teeth like full coverage crowns, which depend on mechanical retention, are being replaced by modern methods which depend on adhesion. This shift was attributed to the increased popularity of the minimally invasive dentistry philosophy, and the development of reliable adhesive systems, as well as the etchable ceramics. The preservation of coronal tooth structure is crucial for clinical success and for maintaining biomechanical, adhesive, functional, and esthetic balance. The advent of adhesive dentistry and advancement in dental materials have resulted in mechanical properties close to the dental tissues, thereby offering a conservative treatment option to restore, reinforce, and protect endodontically treated teeth (ETT). Directly bonded restorations are indicated for teeth with the minimal loss of coronal tooth structure and can be considered effective for short-term success of root canal treated teeth. However, indirect restorations could be considered for the strengthening of the tooth with moderate loss of tooth structure, following the adequate adhesive protocols. This clinical study evaluates indirect adhesive restorations such as endocrowns, adhesive inlays, and onlays for the duration of 1,3,6,12 months. |