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NCT Number: NCT06947070

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

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.

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIDS

Rohtak, Haryana, India

Location status: Recruiting

Location contact

Manu Rathee, MDS

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manu Rathee, MDS

CONTACT

[email protected]

09416141376

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study 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"

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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