| CTRI Number |
CTRI/2025/09/095299 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Endo-telescopic crown versus cast post and core with porcelain fused metal crown |
|
Scientific Title of Study
|
Comparative evaluation of clinical outcomes between CAD lithium disilicate Endo-telescopic crown and cast metal post and core with porcelain fused metal crown in the endodontically treated anterior tooth: A randomized controlled trial |
| 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 Shruti Potdukhe |
| Designation |
PhD Scholar |
| Affiliation |
Government Dental college and Hospital, Nagpur |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MEDICAL SQUARE, NAGPUR
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9096915009 |
| Fax |
|
| Email |
shrutispotdukhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Khalikar |
| Designation |
Professor and HOD |
| Affiliation |
Government Dental college and Hospital, Nagpur |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MEDICAL SQUARE, NAGPUR
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422201961 |
| Fax |
|
| Email |
drkhalikar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Potdukhe |
| Designation |
PhD Scholar |
| Affiliation |
Government Dental college and Hospital, Nagpur |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MEDICAL SQUARE, NAGPUR
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9096915009 |
| Fax |
|
| Email |
shrutispotdukhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental college and hospital, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Potdukhe |
| Address |
Government Dental college and hospital, Nagpur, Maharashtra, India 440003 |
| 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 Shruti Potdukhe |
Government Dental college and Hospital |
Department of Prosthodontics and Crown & Bridge, Ground floor
Nagpur
MAHARASHTRA |
9096915009
shrutispotdukhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College and Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K030||Excessive attrition of teeth, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD lithium disilicate endo-telescopic crown |
Evaluation will be done for 18 months |
| Comparator Agent |
Cast metal post and core and porcelain fused metal crown |
Evaluation will be done for 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in the study.
Patients of both genders with the age range of 18 to 65 years.
Root canal-treated anterior tooth which is used as
an abutment for crown placement.
Root canal-treated anterior tooth where at least 1/3rd of natural crown is present.
Ellis class III fracture of anterior tooth.
Patient with root canal treated tooth with no periapical radiolucency present.
Anterior tooth with calcified canals
Anterior tooth with narrow canals
Any periodontal phenotype (thick or thin).
Patient with good oral hygiene.
No intraoral soft and hard tissue pathology
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patient of any gender less than 18 years of age.
Patient with limited mouth opening.
Patient with periapical radiolucency present
Patient with faulty root canal treated teeth
Vertical or horizontal root fracture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success rate, survival rate, patient satisfaction, color stability |
baseline, 6 months, 12 months, 18 months |
|
|
Secondary Outcome
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| 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="3"
Months="0"
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
|
Natural tooth is the source of the perfect balance between the health of oral hard and soft tissues, maintaining the appearance, function, bone volume, sensory perception and natural defence mechanism. Extraction of natural tooth contributes to loss of natural parts and function which can never be revived again. Preservation and utilization of every segment of the natural tooth till it is completely deprived should be the aim of every dentist which will add on certain period to the tooth’s life. Certain clinical conditions like calcified canals, narrow canals, severely resorbed teeth, Ellis class III fracture tooth, root canal treated tooth with 1/3rd of tooth structure present, when the remaining tooth is healthy, the crown is healthy, the roots are healthy, no periapical radiolucency no infection but the problem exists in the reduced crown structure or loss of crown structure, the problem with root canal space which is calcified, narrowed down. In such cases when the tooth is healthy the remaining structure can be used for prosthetic rehabilitation. The present study aims to evaluate and compare the CAD lithium disilicate Endo-telescopic crown and cast metal post with porcelain fused metal crown in the endodontically treated anterior tooth for assessment of success rate, survival rate, color stability and patient satisfaction so that it will give the clinician a choice of optimum metal-free treatment for prosthetic rehabilitation of the root canal treated anterior tooth having 1/3rd of remaining tooth structure for a more durable and successful outcome and eliminating the need of extraction of a tooth when the remaining tooth structure is healthy. This will lead to the preservation of naturally healthy tooth with the different designs and prevent the need for replacement by an artificial substitute.
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