| CTRI Number |
CTRI/2025/04/084803 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Checking marginal fit and gum changes after giving lithium disilicate crowns in anterior teeth |
|
Scientific Title of Study
|
Comparative evaluation of marginal adaptability and gingival response for endodontically treated anterior teeth with lithium disilicate crowns and 2 finish line designs A randomized clinical 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 Chandani Joshi |
| Designation |
Post graduate student |
| Affiliation |
Narsinhbhai patl dental college and hospital |
| Address |
Prosthodontic crown and bridge,
Narsinhbhai Patel dental college and hospital,
Visnagar
Narsinhbhai patel dental college and hospital,
Sankalchand patel university,
Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
9898073440 |
| Fax |
|
| Email |
chand9828@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vilas Patel |
| Designation |
Professor and Dean |
| Affiliation |
Narsinhbhai patl dental college and hospital |
| Address |
Narsinhbhai patel dental college and hospital,
visnagar
Narsinhbhai patel dental college and hospital,
Sankalchand patel university,
Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
9898073440 |
| Fax |
|
| Email |
vilas17@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandani Joshi |
| Designation |
Post graduate student |
| Affiliation |
Narsinhbhai patl dental college and hospital |
| Address |
Narsinhbhai patel dental college and hospital,
Sankalchand patel university,
Visnagar
Narsinhbhai patel dental college and hospital,
Sankalchand patel university,
Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
9898073440 |
| Fax |
|
| Email |
chand9828@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department number 3, Narsinhbhai Patel Dental College and Hospital, Visnagar-384315,
Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr. Chandani Joshi |
| Address |
10, Anusthan Bunglows,
Science city road,
Ahmedabad |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vilas Patel |
Narsinhbhai Patel Dental College and Hospital,
Sankalchand Patel University,
Visnagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandani Joshi |
Narsinhbhai patel dental college and hospital |
Deaprtment number 3, Narsinhbhai patel dental college and hospital, visnagar- 384315
Mahesana
GUJARAT |
9898073440
chand9828@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narsinhbhai Patel Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 finish line designs |
Lithium disilicate crowns given with radial shoulder and heavy chamfer finish line designs
|
| Comparator Agent |
NIL |
NIL |
| Intervention |
Two different impression techniques |
Conventional or digital impression techniques are considered |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Endodontically treated anterior teeth
2.Patients with good periodontal health
3.Patients in good general health |
|
| ExclusionCriteria |
| Details |
1.Posterior teeth
2.Gingival recession
3.Chronic systemic disease
4.Carious teeth |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Find the best finish lines for endodontically treated anterior teeth restored with lithium disilicate crowns: Radial shoulder or heavy chamfer |
180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Find the best method for impression: digital or conventional |
1 year follow up |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
15/05/2025 |
| 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="1"
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
|
88 endodontically treated teeth will be selected from the patients after written consent from the patients coming in the department of Prosthodontics and Crown & Bridge, NPDCH, Visnagar. Tooth preparations will be done giving 2 finish lines designs: radial shoulder and heavy chamfer for restoring with lithium disilicate crowns. Two impression methods will be used: conventional and digital. Gingival response and marginal adaptability will be checked at the time of cementation, 3, 6 and 12 months follow up. The best finish line design and best modality for impression taking will be observed. |