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Recruiting NCT06947070

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

No phase Interventional DENTAL IMPLANTATION

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: To evaluate the surface topography and color stability of 3D printing provisional material..
Who it may be relevant to
Registry conditions: DENTAL IMPLANTATION. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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"

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Surface topography of provisional restorations. [Time frame: 2 years]
  • Color stability of provisional restorations [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

India · 1 center
  • PGIDS — Rohtak

Identifiers

NCT: NCT06947070 · Dr. Kritika Diwan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗