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

NCT06947070 | Recruiting DMC

• 1 other identifier: Dr. Kritika Diwan
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

DENTAL IMPLANTATION

Keywords

3D printed provisional restorations

Outcome Measures

Primary Outcomes (2)

• Surface topography of provisional restorations.

  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

  The color stability of implant supported provisional restorations fabricated using two different 3D printing materials evaluated using Spectrophotometer.

  2 years

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, India

RECRUITING

Study Officials

• Kritika Diwan, BDS

  PGIDS, Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manu Rathee, MDS

CONTACT

09416141376; ratheemanu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: April 27, 2025
• Study Start: July 1, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 30, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)