| CTRI Number |
CTRI/2024/06/068622 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison in terms of gap,health of gums,appearance of two different composite tooth colored caps. |
|
Scientific Title of Study
|
Comparative evaluation of marginal fit, periodontal response and clinical performance of teeth restored with 3D printed and CAD CAM milled composite crowns -A randomized controlled clinical 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 Sayam Shah |
| Designation |
Postgraduate student |
| Affiliation |
k m shah dental college |
| Address |
Number 9 Department of Prosthodontics crown and Bridge sumandeep vidyapeeth K M shah dental college pipariya waghodiya vadodara
GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9588621273 |
| Fax |
|
| Email |
sayamshah99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sethuraman |
| Designation |
Head of the Department of Prosthodontics Crown and Bridge |
| Affiliation |
k m shah dental college |
| Address |
Number 9 Department of Prosthodontics crown and Bridge sumandeep vidyapeeth K M shah dental college pipariya waghodiya vadodara
GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9725038434 |
| Fax |
|
| Email |
rajeshsethu77academics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayam Shah |
| Designation |
Postgraduate student |
| Affiliation |
k m shah dental college |
| Address |
Number 9 Department of Prosthodontics crown and Bridge sumandeep vidyapeeth K M shah dental college pipariya waghodiya vadodara
GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9588621273 |
| Fax |
|
| Email |
sayamshah99@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M SHAH Dental college and hospital pipaliya waghodiya gujrat india 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Sayam Shah |
| Address |
Number 9 Department of Prosthodontics crown and Bridge sumandeep vidyapeeth K M shah dental college pipariya waghodiya vadodara
GUJARAT |
| 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 Sayam Shah |
K M SHAH Dental college and hospital |
Department of prosthodontics crown and bridge dental division room number 9 k m shah dental college sumandeep vidyapeeth pipaliya waghodiya vadodara 391760
Vadodara
GUJARAT |
9588621273
sayamshah99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth 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 |
3D printed composite crowns |
These crowns are printed by layer by layer approach and are given on permanent teeth and followed up for 1 year time period. |
| Comparator Agent |
Milled composite crowns |
These crowns are milled by blanks or blocks of composite and given on permanent teeth and followed up for 1 year time period. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Participants requiring at least two crowns in maxillary or mandibular permanent posterior teeth with following indications
1 Teeth restored with large filling restorations.
2 Endodontically treated teeth.
3 Malformed teeth
4 Occlusal function with a natural tooth
5 No tooth mobility
6 Teeth with sound gingival and periodontal health
7 Psychologically and physically able to co-operate during the tooth preparation procedure.
8 Ability and willingness of patient to come for required appointments.
|
|
| ExclusionCriteria |
| Details |
1 Patients in growth stage with partially erupted teeth
2 Patients with medical history in which any dental intervention would be contraindicated
3 Patients with any local or systemic disease or condition or medication that might compromise health of the periodontium
4 Patient with clinical sign or history of bruxism
5 Patients who use tobacco in any form
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Marginal fit periodontal response and clinical performance |
At baseline,3 months and six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
01/08/2024 |
| 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
|
Fixed dental prostheses are widely used to replace missing teeth. A crucial factor for their success is a good marginal fit, which prevents issues like micro-leakage and gum problems.
With advancements, dentists now have various materials for fixed partial denture. This study aims to compare 3D-printed resin crowns with milled composite crowns. While milled crowns have limitations, 3D printing offers better control and precision.
There’s no existing data on the clinical performance of 3D-printed permanent fixed partial denture. This study will evaluate how well 3D-printed resins compare to milled composite crowns in terms of marginal fit, gum health, and overall performance over a year.
The hypothesis is that 3D-printed resins may lead to better clinical outcomes due to potentially superior marginal fit.
The study will compare 3D-printed resin crowns with milled composite crowns for single tooth restoration.
Steps include:
1. Screening patients and obtaining consent. 2. Randomly assigning patients to either group (3D-printed or milled crowns). 3. Preparing the teeth for crowns. 4. Taking digital impressions and designing crowns. 5. Fabricating crowns (3D-printed or milled). 6. Evaluating marginal fit of the crowns. 7. Cementing the crowns. 8. Monitoring patients’ gums and plaque buildup for 1 year. 9. Evaluating the clinical performance of the crowns for 1 year. 10. Analyzing the data. |