Clinical trial NCT06946693: Surface Topography and Color Stability of Conventional, 3D Printed, and Milled Provisional Restorations.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: PROVISIONAL RESTORATIONS
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.
timeFrame: 1 year 6 months
measure: Color stability of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing.
timeFrame: 1 year 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: POST GRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK, HARYANA
name: NALIKA MOUNGKHOM, BACHELOR OF DENTAL SURGERY
role: PRINCIPAL_INVESTIGATOR
References: