Edentulous Jaw Clinical Trial
Official title:
Performance of CAD/CAM Milled and 3D-printed Full-arch Implant-supported Provisionals Restorations: A Randomized Controlled Clinical Trial
Verified date | July 2023 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial aims to compare the performance of CAD/CAM-milled and 3D-printed full-arch implant-supported provisional restorations in patients at the Advanced Implant Prosthetics Clinic of the Complutense University of Madrid, of both sexes, over 18 years of age, edentulous upper, lower or both, whose treatment plan is at least a fixed implant-supported rehabilitation of the complete arch. The main question it aims to answer is if there are differences in the mechanical behavior and optical properties of the materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology through machining or 3D printing. Participants will: - Receive milled (control material: PMMA; Multilayer PMMA block, HUGE; Shandong Huge Dental Material Corporation) or printed (test material: 3D impression resin; VarseoSmile Temp, Bego Bremer Goldschägerei Wilh. Herbst GmbH & Co. KG, Bremen) and they will be in provisional phase for 3 months doing daily life. Researchers will compare PMMA (Multilayer PMMA block, HUGE; Shandong Huge Dental Material Corporation) and the printed-resin (3D impression resin; VarseoSmile Temp, Bego Bremer Goldschägerei Wilh. Herbst GmbH & Co. KG, Bremen) to see: - Mechanical behavior and the absence of complications, fracture of the structure, material jumping or wear, loosening, or detachment. - Optical properties, initial color, and degradation of the materials used
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Males and females at least 18 years of age. - Healthy patients; ASA I or ASA II. - Maxillary, mandibular, or both maxillary edentulous patients whose prosthetic treatment plan is a full-arch implant-supported fixed prosthesis. - Patients must have voluntarily signed informed consent, be willing and able to attend scheduled follow-up visits, and agree to have coded data collected and analyzed. Exclusion Criteria: - Any contraindications for oral surgical procedures. - Smokers classified as "heavy smokers" above 10 cigarettes per day (or more than 1 cigar per day) or smokers of chewing tobacco. - Subjects with drug or alcohol abuse. - Severe bruxing habits. - Conditions or circumstances that, in the opinion of the investigator, would preclude completion of participation in the study or interfere with the analysis of the study results. |
Country | Name | City | State |
---|---|---|---|
Spain | School of Dentistry, Complutense University. Pza Ramón y Cajal s/n. | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mechanical behavior of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology. | The mechanical behavior will be evaluated on the basis of the occurrence of some mechanical complications. The mechanical complications to be evaluated will be classified by visual inspection in clinical examination as follows:
Appearance of material skips, minor fractures and/or chipping Appearance of major fractures defined as an appearance of a broken structure that restrain the use of the devise. |
2 years | |
Primary | Optical properties of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology. | The optical properties of the material will be based on the initial color of the material and its degradation from color acquisition using a Vita Easyshade® compact spectrophotometer (Vita, Zahnfabrik - Germany). Five measurements of tooth 1.1 or 4.1 depending on the maxilla will be taken on the day of provisional placement and after three months, the system code of the VITA classical and 3D Master shade guides will also be recorded. In addition, the coordinates of the CIELAB chromatic notation system will be recorded with which the brightness (L), chroma (C) and hue (h) and the differences in brightness (?L) , chroma differences (?C) and hue differences (?H) will be evaluated. | 2 years |
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