| CTRI Number |
CTRI/2025/12/098794 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of how well zirconia dental crowns made using Artificial Intelligence and CAD-CAM techniques fit in patients |
|
Scientific Title of Study
|
Comparative Evaluation of Marginal and Internal fit of Zirconia Crown designed using Artificial Intelligence (AI Software) and CAD-CAM Software. An In-Vivo 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 Pritesh O Gangde |
| Designation |
PhD candidate |
| Affiliation |
Sharad Pawar Dental College and Hospital, |
| Address |
202 Department or Prosthodontics Sharad Pawar Dental College and Hospital
Wardha
MAHARASHTRA
442004
India |
| Phone |
07000626186 |
| Fax |
|
| Email |
gangdedentalclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta Kale |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College and Hospital, |
| Address |
202 Department or Prosthodontics Sharad Pawar Dental College and Hospital
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000626186 |
| Fax |
|
| Email |
drsweta15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
202 Department or Prosthodontics Dr Sweta Kale |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College and Hospital, |
| Address |
Sharad Pawar Dental College and Hospital
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000626186 |
| Fax |
|
| Email |
drsweta15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institutional funding Sharad Pawar Dental College and Hospital DMIHER |
| Address |
202 Department or Prosthodontics Sharad Pawar Dental College and Hospital DMIHER 442001 India |
| Type of Sponsor |
Research institution |
|
|
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 Pritesh O Gangde |
202 Department of rostodntics Sharad Pawar Dental College and Hospital |
Sharad Pawar Dental College and Hospital
Wardha
MAHARASHTRA |
07000626186
gangdedentalclinic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & ResearchInstitutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Zirconia crown designed using artificial intelligence based dental design software |
Participants will receive a zirconia crown designed through an artificial intelligence driven digital dental design software. The workflow includes intra oral digital scanning of the prepared mandibular first molar, automated crown design generation using artificial intelligence algorithms, fabrication of the zirconia crown through computer aided manufacturing, placement of the crown on the prepared tooth, and evaluation of marginal and internal fit through standardized digital measurement methods.6 months |
| Comparator Agent |
Zirconia crown designed using computer aided design and computer aided manufacturing software |
Participants will receive a zirconia crown designed through a conventional computer aided design and computer aided manufacturing dental software. The workflow includes intra oral digital scanning of the prepared mandibular first molar, manual crown design using computer aided design tools, fabrication of the zirconia crown using computer aided manufacturing, placement of the crown on the prepared tooth, and evaluation of marginal and internal fit through standardized digital measurement methods. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged eighteen to sixty five years requiring zirconia crown restoration of an endodontically treated mandibular first molar. Participants must have good general health and good periodontal health, with no active periodontal disease. The selected tooth should be free from caries, fractures, significant wear, or any condition that may affect crown preparation. Only teeth that can be prepared according to standardized guidelines for zirconia crown placement will be included. Participants should be able to provide informed consent and comply with study procedures and follow up visits. |
|
| ExclusionCriteria |
| Details |
Patients younger than eighteen years or older than sixty five years. Teeth other than mandibular first molars. Teeth with caries, fractures, extensive wear, or previous restorations that may interfere with standardized crown preparation. Patients with poor oral hygiene or active periodontal disease. Patients with systemic conditions that may affect dental treatment or healing, including uncontrolled diabetes or immunosuppressive disorders. Participants unable to comply with study requirements or follow up. Individuals with known allergies to materials used in zirconia crown fabrication. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean marginal gap distance at the crown tooth interface for zirconia crowns on mandibular first molars on buccal, lingual, mesial and distal aspects, measured digitally in micrometers. |
Single assessment immediately after cementation and final seating of the zirconia crown on the prepared tooth. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean internal fit distance between the inner surface of the zirconia crown & the prepared tooth structure on occlusal, buccal, lingual, mesial & distal aspects, measured digitally in micrometers. |
Single assessment immediately after cementation & final seating of the zirconia crown on the prepared tooth.6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/02/2026 |
| 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 Yet Recruiting |
| 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
|
This study aims to compare the marginal fit and internal fit of zirconia dental crowns designed using artificial intelligence based dental design software with zirconia crowns designed using conventional computer aided design and computer aided manufacturing software. Adults aged eighteen to sixty five years who require zirconia crown restoration of an endodontically treated mandibular first molar will be included. After tooth preparation, an intra oral digital scan will be obtained. One group will receive a zirconia crown designed through artificial intelligence software and the other group will receive a zirconia crown designed through conventional computer aided design and computer aided manufacturing software. All crowns will be fabricated from zirconia and placed on the prepared tooth. Digital evaluation methods will be used to measure the marginal gap and internal adaptation of each crown. The study will assess differences in accuracy of fit between the two design systems. The findings may help clinicians select the most suitable digital design workflow for improving the quality of zirconia crown restorations. |