Surface Topography and Color Stability of Implant Supported 3D Printed Provisional Restorations

April 19, 2025 updated by: Postgraduate Institute of Dental Sciences Rohtak

"Comparative Evaluation of Surface Topography and Color Stability of Implant Supported Provisional Restorations Fabricated Using Two Different 3D Printing Materials in Mandibular Posterior Region: A Randomized Clinical Trial"

Patient attending the Outdoor Patient Department of the Department of Prosthodontics at Post Graduate Institute of Dental Sciences, Rohtak will be screened. The screening will include history taking and clinical examination of the partially edentulous patients. Patients will be selected according to the inclusion and exclusion criteria. Single stage endosseous implants will be placed. Two different Biocompatible 3D printed Polymethyl methacrylate resin will constitute two groups, Group A and Group B. 3D printed provisional poly methyl methacrylate resin crowns will be fabricated with Group- A and Group-B material followed by evaluation of surface topography and color stability after intraoral use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Title: "Comparative Evaluation of Surface Topography and Color Stability of Implant Supported Provisional Restorations Fabricated using Two Different 3D Printing Materials in Mandibular Posterior Region: A Randomized Clinical Trial".

Rationale: The study needs to verify the surface topography and color stability of implant supported provisional restorations fabricated using two different 3D printing materials in mandibular posterior region.

Aim and objectives: To evaluate the surface topography and color stability of implant supported provisional restorations fabricated using two different 3D printing materials in mandibular posterior region.

Setting: Department of Prosthodontics and Crown & Bridge, PGIDS Rohtak. Study Design: Randomised clinical trial. Population/Participants: Provisional restoration will be fabricated using two different 3D printing materials.

Sample Size: Total of 24 samples will be prepared (n=12 samples per test group).

Methodology: This is an in-vivo study and will be carried out in the Department of Prosthodontics and Crown & Bridge, Post Graduate Institute of Dental Sciences, Rohtak with the purpose to evaluate the surface topography and color stability of implant supported provisional restorations fabricated using two different 3D printing materials in mandibular posterior region.

Outcome Measures: Measuring the surface topography using profilometer and color stability using spectrophotometer.

Statistical Analysis: Data obtained would be compiled on MS Office Excel Sheet (v 2010) and will be subjected to statistical analysis using statistical package for social sciences (SPSS v 21.0, IBM). Intergroup and intragroup comparisons will be done according to distribution of data.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Haryana
      • Rohtak, Haryana, India
        • Recruiting
        • PGIDS
        • Contact:
          • Manu Rathee, MDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects consented to participate in the study.
  2. Subjects with maintainable oral hygiene.
  3. Subjects with adequate edentulous space at the prospective implant site.
  4. Subjects with availability of adequate quantity and quality of bone.

Exclusion Criteria:

  1. Subject with presence of infection around proposed site of implant placement.
  2. Subjects with any condition that would interfere with the soft tissue and bone healing.
  3. Subjects in which surgical procedure is contraindicated for any reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: To evaluate the surface topography and color stability of Group I 3D printing provisional material.
Procedure: To evaluate the surface topography and color stability of 3D printing provisional material.
Subjects with single stage implant placement followed by early non-functional loading with implant supported provisional restorations fabricated using 3D printing provisional material.
Active Comparator: To evaluate the surface topography and color stability of Group II 3D printing provisional material.
Procedure: To evaluate the surface topography and color stability of 3D printing provisional material.
Subjects with single stage implant placement followed by early non-functional loading with implant supported provisional restorations fabricated using 3D printing provisional material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface topography of provisional restorations.
Time Frame: 2 years
The surface topography of implant supported provisional restorations fabricated using two different 3D printing materials evaluated using Profilometer.
2 years
Color stability of provisional restorations
Time Frame: 2 years
The color stability of implant supported provisional restorations fabricated using two different 3D printing materials evaluated using Spectrophotometer.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: Kritika Diwan, BDS, PGIDS, ROHTAK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

April 24, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dr. Kritika Diwan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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