Clinical Performance Clinical Trial
Official title:
Evaluation of 3D Printed Polyether Ether Ketone (PEEK) and Milled PEEK Indirect Restorations Compared to Hybird Resin Composite Indirect Restorations Over One Year Period of Time ( A Randomized Clinical Trial )
Verified date | October 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical performance evaluation of 3D Printed Polyether ether ketone (PEEK) and milled PEEK indirect restorations compared to hybird resin composite indirect restorations over one year period of time
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | April 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Patients aging (18-45) years. - Patients with a high level of oral hygiene. - Each patient enrolled in the study should have moderate carious lesion or defective restoration needs to be replaced on a mandibular permanent molar. - Patients with ability to attend periodical follow-ups. Exclusion Criteria: - Patients with general/systemic diseases or allergies. - Patients with chronic use of anti- inflammatory, analgesic, and psychotropic drugs. - Pregnant or lactating females. - Patients with parafunctional habits. - Patients with experience of allergic reactions against any components of the used materials. - Patients receiving orthodontic treatment. - Inability to comply with study procedures. - Collateral participation in another research study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Cairo University |
Abhay SS, Ganapathy D, Veeraiyan DN, Ariga P, Heboyan A, Amornvit P, Rokaya D, Srimaneepong V. Wear Resistance, Color Stability and Displacement Resistance of Milled PEEK Crowns Compared to Zirconia Crowns under Stimulated Chewing and High-Performance Aging. Polymers (Basel). 2021 Oct 30;13(21):3761. doi: 10.3390/polym13213761. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fracture and retention (Category F1)(Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting) | Outcome:Fracture of the material and retention Measuring device: Revised FDI criteria for evaluating direct and indirect dental restorations- recommendations for its clinical use, interpretation, and reporting.
(Hickel et al., 2023) Measuring unit: Scoring system (Ordinal) 1. Clinically excellent/very good (sufficient) 2. Clinically good (sufficient) 3. Clinically satisfactory (sufficient) 4. Clinically unsatisfactory (partially insufficient) 5. Clinically poor (entirely insufficient) |
Baseline, 6 months, 12 months | |
Secondary | occlusion and wear (Category F5) | Wear potential of the restoration Measuring device: A. Digital scanner (CEREC Primescan intraoral Scanner) B. Geometrical Subtraction software (Geomagic control software) (Tang et al. 2021) Measuring unit : Microns (Quantitative) | Baseline, 6 months, 12 months |
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