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NCT Number: NCT06946693

Surface Topography and Color Stability of Conventional, 3D Printed, and Milled 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, consent 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. Provisional restorations fabricated by conventional technique, milling, and 3D printing will constitute three groups, followed by evaluation of color stability and surface roughness 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

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location status: Recruiting

Location contact

MANU RATHEE, MASTER OF DENTAL SURGERY

CONTACT

[email protected]

+91 9416141376

NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY

PRINCIPAL_INVESTIGATOR

About this study

Title: "Comparative assessment of the color stability and surface roughness of implant-supported provisional restorations fabricated by conventional technique, milling, and 3D printing: A randomized controlled clinical trial" Rationale: The study needs to verify the color stability and surface roughness of implant-supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

Aim and objectives: To evaluate the color stability and surface roughness of implant-supported provisional prosthesis fabricated using conventional technique, milling, and 3D printing in the mandibular posterior region.

Setting: Department of Prosthodontics and Crown & Bridge, PGIDS, Rohtak. Study Design: Randomized controlled clinical trial. Population/Participants: Provisional restoration will be fabricated using conventional technique, milling and 3D printing.

Sample Size: Total of 36 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 color stability and surface roughness of implant-supported provisional restorations fabricated using conventional technique, milling, and 3D printing in the mandibular posterior region.

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

Statistical Analysis: Data obtained will 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 the 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. 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.

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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 reason.

-

Treatment and study plan

To evaluate the color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region.

Procedure

Subjects with single stage implant placement and early non-functional loading with implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

Primary outcomes

  1. Surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

    Time frame: 1 year 6 months

    Surface roughness of provisional restorations will be measured using profilometer

  2. Color stability of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

    Time frame: 1 year 6 months

    Color stability of provisional restorations will be measured using spectrophotometer

Study contacts

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

MANU RATHEE, MASTER OF DENTAL SURGERY

CONTACT

[email protected]

+91 9416141376

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

Comparative Assessment of the Color Stability and Surface Roughness of Implant-Supported Provisional Restorations Fabricated by Conventional Technique, Milling and 3D Printing: A Randomized Controlled Clinical Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
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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