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

NCT05958043 | Completed

• 1 other identifier: 22/170-EC_P
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Edentulous Jaw; Dental Prosthesis Complication; Dental Prosthesis Failure

Keywords

CAD/CAM; 3D-Printed; Full-arch provisional

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

3D-printed group

EXPERIMENTAL

The patients randomized to the 3D-printed group will receive a 3D-printed full arch implant-supported provisional restoration.

Device: 3D- printed Full-arch Implant-supported Provisionals Restorations

CAD/CAM- milled group

OTHER

The patients randomized to the CAD/CAM-milled group will receive a PMMA-milled full-arch implant-supported provisional restoration.

Device: CAD/CAM-milled Full-arch Implant-supported Provisionals Restorations

Interventions

3D- printed Full-arch Implant-supported Provisionals Restorations DEVICE

The full-arch provisional restorations will be placed on dental implants that should be positioned to allow for the fabrication of a prosthesis that spans at least 12 units (from the right first molar to the left first molar, accepting distal extensions). Before completing the essential clinical data registration to produce an individual patient-oriented prosthesis, trans-epithelial abutments will be put at the torque the manufacturer recommends (30-35 Ncm typically), according to the appropriate gingival height. At visit three, the full-arch provisional will be screwed in using the manufacturer's specified torque (15 Ncm typically). For 12 to 15 weeks (about three months), the patient will be in the preliminary phase, during which time data will be gathered. Once the stipulated time has elapsed, the definitive prosthesis in monolithic zirconia prosthesis will be placed.

3D-printed group

CAD/CAM-milled Full-arch Implant-supported Provisionals Restorations DEVICE

The full-arch provisional restorations will be placed on dental implants that should be positioned to allow for the fabrication of a prosthesis that spans at least 12 units (from the right first molar to the left first molar, accepting distal extensions). Before completing the essential clinical data registration to produce an individual patient-oriented prosthesis, trans-epithelial abutments will be put at the torque the manufacturer recommends (30-35 Ncm typically), according to the appropriate gingival height. At visit three, the full-arch provisional will be screwed in using the manufacturer's specified torque (15 Ncm typically). For 12 to 15 weeks (about three months), the patient will be in the preliminary phase, during which time data will be gathered. Once the stipulated time has elapsed, the definitive prosthesis in monolithic zirconia prosthesis will be placed.

CAD/CAM- milled group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

School of Dentistry, Complutense University. Pza Ramón y Cajal s/n.

Madrid, Madrid, 28040, Spain

Location

Related Publications (16)

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  PMID: 31810613 BACKGROUND

• Mayer J, Reymus M, Wiedenmann F, Edelhoff D, Hickel R, Stawarczyk B. Temporary 3D printed fixed dental prosthesis materials: Impact of post printing cleaning methods on degree of conversion as well as surface and mechanical properties. Int J Prosthodont. 2021 November/December;34(6):784-795. doi: 10.11607/ijp.7048. Epub 2021 Feb 12.

  PMID: 33616559 BACKGROUND

• Molinero-Mourelle P, Canals S, Gomez-Polo M, Sola-Ruiz MF, Del Rio Highsmith J, Vinuela AC. Polylactic Acid as a Material for Three-Dimensional Printing of Provisional Restorations. Int J Prosthodont. 2018 Jul/Aug;31(4):349-350. doi: 10.11607/ijp.5709.

  PMID: 29953566 BACKGROUND

• Shin SH, Kwon JS, Shim JS, Kim JE. Evaluating the Three-Dimensional Printing Accuracy of Partial-Arch Models According to Outer Wall Thickness: An In Vitro Study. Materials (Basel). 2021 Nov 9;14(22):6734. doi: 10.3390/ma14226734.

  PMID: 34832136 BACKGROUND

• Shin SH, Doh RM, Lim JH, Kwon JS, Shim JS, Kim JE. Evaluation of Dimensional Changes According to Aging Period and Postcuring Time of 3D-Printed Denture Base Prostheses: An In Vitro Study. Materials (Basel). 2021 Oct 18;14(20):6185. doi: 10.3390/ma14206185.

  PMID: 34683773 BACKGROUND

• Srinivasan M, Kalberer N, Fankhauser N, Naharro M, Maniewicz S, Muller F. CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures. J Dent. 2021 Dec;115:103842. doi: 10.1016/j.jdent.2021.103842. Epub 2021 Oct 9.

  PMID: 34637889 BACKGROUND

• Tangpothitham S, Pongprueksa P, Inokoshi M, Mitrirattanakul S. Effect of post-polymerization with autoclaving treatment on monomer elution and mechanical properties of 3D-printing acrylic resin for splint fabrication. J Mech Behav Biomed Mater. 2022 Feb;126:105015. doi: 10.1016/j.jmbbm.2021.105015. Epub 2021 Nov 29.

  PMID: 34896766 BACKGROUND

• Henderson JY, Korioth TVP, Tantbirojn D, Versluis A. Failure load of milled, 3D-printed, and conventional chairside-dispensed interim 3-unit fixed dental prostheses. J Prosthet Dent. 2022 Feb;127(2):275.e1-275.e7. doi: 10.1016/j.prosdent.2021.11.005. Epub 2021 Dec 10.

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  PMID: 19500895 BACKGROUND

Related Links

• World Health Organization. WHO Framework Convention on Tobacco Control
• Study Randomizer \[App/Ethernet\]. Wageningen. 2017

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Miguel Gómez Polo, DDS, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of conservative dentistry and prosthodontics

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: March 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: July 30, 2025
• Last Updated: December 26, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: the following data will be shared and available: * Participant's data that underlie the results reported in this article, after deidentification (text, tables, figures). * Other documents that would be available: Study protocol. The data and protocols may be only available to investigators and researchers who provide a methodologically sound proposal for individual participant data meta-analysis. The data would be available beginning 6 months and ending 5 years following article publication and it may be shared after a proposal is directed.
• Access Criteria: To gain access, data requestors will need to sign a data access agreement.

Locations

ES (1)