| CTRI Number |
CTRI/2025/06/088194 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare wear of two different temporary crown materials and natural teeth. |
|
Scientific Title of Study
|
Comparative evaluation of occlusal wear of computer designed Polymethyl Methacrylate (PMMA) provisional crowns fabricated by milling and 3D printing -A split mouth randomized 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 |
Priyanka Ravindra Pande |
| Designation |
Junior Resident |
| Affiliation |
CDER, AIIMS, New Delhi |
| Address |
2nd floor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institude of Medical Sciences,Sri aurobindo garg, Ansari Nagar East, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
8149769794 |
| Fax |
|
| Email |
priyankarp@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Nanda |
| Designation |
Associate Professor |
| Affiliation |
CDER, AIIMS, New Delhi |
| Address |
2nd floor, room no. 205, Department of Prosthodontics, Centre for Dental Education and Research, All India Institude of Medical Sciences,Sri aurobindo garg, Ansari Nagar East,New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9871167927 |
| Fax |
|
| Email |
aditinanda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Ravindra Pande |
| Designation |
Junior Resident |
| Affiliation |
CDER, AIIMS, New Delhi |
| Address |
2nd floor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institude of Medical Sciences,Sri aurobindo garg, Ansari Nagar East, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
08149769794 |
| Fax |
|
| Email |
priyankarp@aiims.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priyanka Pande |
| Address |
2nd floor, Department of Prosthodontics, Centre for Dental Education and Research , All India Institute of Medical Sciences, Sri Aurobindo Garg, Ansari Nagar East, New Delhi-110029 |
| 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 Priyanka Ravindra Pande |
Centre for Dental Education and Research |
2nd floor, Department of Prosthodontics, Centre for Dental Education and Research, All India Institude of Medical Sciences,Sri aurobindo garg, Ansari Nagar East, Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
08149769794
priyankarp@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Endodontically treated asymptomatic teeth |
| Patients |
(1) ICD-10 Condition: K03||Other diseases of hard tissues ofteeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endodontically treated teeth restored with computer designed polymethyl methacrylate 3D printed provisional crown |
Tooth preparation done in endodontically treated mandibular 1st molar and cemented with computer designed polymethyl methacrylate 3D printed crown and evaluated for occlusal wear and antagonist natural enamel on the day of cementation and 3 months after cementation |
| Intervention |
Endodontically treated teeth restored with computer designed polymethyl methacrylate milled provisional crown |
Tooth preparation done in endodontically treated mandibular 1st molar and cemented with computer designed polymethyl methacrylate milled crown and evaluated for occlusal wear and antagonist natural enamel on the day of cementation and 3 months after cementation. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients requiring bilateral posterior mandibular complete crowns with normal periapical architecture.
2)Teeth restorable with a minimum crown to root ratio of at least 1:1.
3)Teeth with healthy opposing natural teeth.
4)Good oral hygiene and periodontal status.
5)Full complement of teeth (excluding 3rd molars).
6)Patients who will be available for the required follow up period.
7)Patients giving positive informed consent
8)Age group 25-50 years
|
|
| ExclusionCriteria |
| Details |
1)Patients with developmental defects of enamel and dentin.
2)Patients who have undergone re-RCT ( root canal treatment ) in mandibular molars.
3)Parafunctional habits like bruxism, clenching.
4)Temporomandibular joint disorders.
6)Fluorosis, calcium metabolic disorders, osteoporosis.
7)Opposing teeth with caries or wear
8)Malocclusion
9)Systemic diseases
10)Smoking
|
|
|
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 |
To evaluate the occlusal wear of computer designed polymethyl methacrylate based milled and 3D printed provisional crowns with natural antagonist teeth in micrometers
|
3 months after cementation of crown. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the occlusal wear of natural antagonist enamel with computer designed polymethyl methacrylate based milled and 3D printed provisional crowns in micrometers. |
3 months after cementation. |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
30/06/2025 |
| 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="0"
Months="3"
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
|
Wear is the gradual removal of material from surfaces as a result of mechanical or chemical injuries, it can occur through 3 processes erosion attrition and abrasion. Literature is filled with studies on wear
characteristics of various definitive restorative materials. There is scarcity
of in vivo study investigating the wear of PMMA based provisional crowns in
human dentition. There is in vivo study related to wear resistance of CAD CAM
provisional implant restoration. There is in vitro study related to wear of
milled and 3D printed veneers. There is lack of a clinical study comparing
the occlusal wear of computer designed Polymethyl Methacrylate provisional
crowns made by milling and 3D printing. The provisional crowns set the stage
for a definitive crown. Occlusal stability should then be maintained prior to
giving a definitive crown. Therefore this study is planned to compare the
occlusal wear of computer designed PMMA provisional crown fabricated by milling
and 3D printing. |