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

NCT ID: NCT06947070

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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DENTAL IMPLANTATION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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To evaluate the surface topography and color stability of Group I 3D printing provisional material.

Group Type ACTIVE_COMPARATOR

To evaluate the surface topography and color stability of 3D printing provisional material.

Intervention Type PROCEDURE

Subjects with single stage implant placement followed by early non-functional loading with implant supported provisional restorations fabricated using 3D printing provisional material.

To evaluate the surface topography and color stability of Group II 3D printing provisional material.

Group Type ACTIVE_COMPARATOR

To evaluate the surface topography and color stability of 3D printing provisional material.

Intervention Type PROCEDURE

Subjects with single stage implant placement followed by early non-functional loading with implant supported provisional restorations fabricated using 3D printing provisional material.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kritika Diwan, BDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS, Rohtak

Locations

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PGIDS

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Manu Rathee, MDS

Role: CONTACT

09416141376

Facility Contacts

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Manu Rathee, MDS

Role: primary

Other Identifiers

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Dr. Kritika Diwan

Identifier Type: -

Identifier Source: org_study_id

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