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Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla

NCT07574099 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-07

No results posted yet for this study

Summary

The goal of this clinical trial is to compare immediate versus early loading protocols for complete implant-supported fixed dental prostheses in healed edentulous maxillae.

The main questions it aims to answer are:

* How does the timing of delivery of the prosthesis affect the stability of the implant and the surrounding soft and bone tissue?
* Does prosthesis delivery time affect quality of life and patient satisfaction? Researchers will compare immediate and early (6 weeks after implant placement) loading protocols in rehabilitation of fully edentulous upper jaw.

Participants will:

* Receive 6 dental implants in the edentulous upper jaw and after that complete fixed dental prostheses will be delivered immediately or 6 weeks after implant placement.
* Visit the clinic at the scheduled time for checkups and tests

Conditions

  • Maxilla
  • Tooth Loss / Rehabilitation

Interventions

DEVICE

Immediate implant loading

Implants will be immediately loaded using S-R abutments (Institut Straumann) with temporary restorations. An open-tray impression technique was used for provisional restoration. Provisional restorations were made digitally with polymethyl methacrylate (PMMA) (Telio CAD, Ivoclar Vivadent, Schaan, Lichtenstein). Plaster models with scan bodies were digitized with a laboratory scanner (3Shape E1, 3Shape, Copenhagen, Denmark). Final virtual design of provisional restoration was performed with 3D design software (exocad Matera 2.3, Exocad, Darmstadt, Germany). Drilling of PMMA blocks was performed in a 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). After 6 weeks they will receive final prosthesis.

DEVICE

Early loading

At the end of the 6-week healing period, definitive prosthetic restorations were delivered. In preparation for the definitive prosthesis, a final open-tray impression was taken with an individual tray and polyether material (Impregum Soft, 3M Espe, Seefeld, Germany). An analog ceramic layering technique was performed in the process of producing a porcelain fused to metal restoration (Shofu Vintage Halo Porcelain, Shofu Dental Corporation, Ratingen, Germany). The metal framework was made using cobalt chromium metal powder material (Starbond Easy Powder 45, Scheftner, Mainz, Germany) with additive manufacturing technologies (EOS, Krailling, Germany).

Sponsors & Collaborators

  • Institute Straumann AG, Basel, Switzerland

    collaborator UNKNOWN

  • University of Belgrade

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2035-03-31
Completion
2035-03-31

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574099 on ClinicalTrials.gov