Surface Topography and Color Stability of Conventional, 3D Printed, and Milled Provisional Restorations.

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: 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.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANU RATHEE, MASTER OF DENTAL SURGERY; Phone Number: +91 9416141376; Email: ratheemanu@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Post Graduate Institute of dental sciences
      • Contact: MANU RATHEE, MASTER OF DENTAL SURGERY; Phone Number: +91 9416141376; Email: ratheemanu@gmail.com
      • Contact: NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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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 reason.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: To evaluate the surface roughness and color stability of Conventional provisional restorations	Procedure: 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.; Subjects with single stage implant placement and early non-functional loading with implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.
Active Comparator: To evaluate the surface roughness and color stability of 3D Printed provisional restorations	Procedure: 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.; Subjects with single stage implant placement and early non-functional loading with implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.
Active Comparator: To evaluate the surface roughness and color stability of Milled provisional restorations	Procedure: 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.; Subjects with single stage implant placement and early non-functional loading with implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.	Surface roughness of provisional restorations will be measured using profilometer	1 year 6 months
Color stability of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.	Color stability of provisional restorations will be measured using spectrophotometer	1 year 6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY, POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK, HARYANA

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2025
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): January 18, 2027

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: PROVISIONAL RESTORATIONS
• Other Study ID Numbers: Dr. NANG NALIKA MOUNGKHOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No