CompletedNot Applicable

Performance of CAD/CAM Milled and 3D-printed Full-arch Implant-supported Provisionals Restorations

Spain20 participantsStarted 2022-03-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mechanical behavior of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.

Timeframe: 2 years

Optical properties of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.

Timeframe: 2 years

Trial details

NCT IDNCT05958043

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Edentulous Jaw trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mechanical behavior of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.

Timeframe: 2 years

Optical properties of 3D-resin and PMMA-milled materials used as provisional materials in full-arch restorations on implants fabricated by CAD/CAM technology.

Timeframe: 2 years