Surface Topography and Color Stability of Conventional, 3D Printed, and Milled Provisional Restorations.
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 color stability and surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing in mandibular posterior region..
- Who it may be relevant to
- Registry conditions: Dental Implant. 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 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.
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, 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.
Interventions
- 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.
Primary outcome measures
- Surface roughness of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing. [Time frame: 1 year 6 months]
- Color stability of implant supported provisional restorations fabricated using conventional technique, milling, and 3D printing. [Time frame: 1 year 6 months]
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
- 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.
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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
- Post Graduate Institute of Dental Sciences — Rohtak
Identifiers
NCT: NCT06946693 · Dr. NANG NALIKA MOUNGKHOM