Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla

NCT07574099 | Active Not Recruiting

• 1 other identifier: 16/36
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

edentulous maxilla; dental implant; implant loading protocol; complete implant-supported fixed dental prostheses

Outcome Measures

Primary Outcomes (1)

• Implant stability

  Implant stability will be recorded by Osstell Mentor and Penguin using Resonance frequency analysis (RFA) method. Results were recorded on an implant stability scale (ISQ) from 1 to 100. The higher the ISQ, the more stable the implant was.21 Two consecutive measurements delivering the same ISQ values were considered authentic.

  Implant stability will be measured at the time of implant placement (baseline) and at post-op week 6 (prior to delivery of definitive prosthetic restoration) and then after 5, 10 and 15 years

Secondary Outcomes (8)

• Insertion torque

  During surgery, at implant placement in prepared implant site.

• Marginal bone loss change from baseline to 5,10 and 15 years follow up

  At final prosthesis delivery (baseline), after 5,10 and 15 years follow up

• Changes in Buccal Plate thickness from baseline to 5,10 and 15 years follow up

  At final prosthesis delivery (baseline) to 5,10 and 15 years follow up

• Oral health-related quality of life

  At implant placement (baseline), 1 month after definitive prosthesis delivery, and after 5,10 and 15 years

• Patient satisfaction

  At implant placement (baseline), 1 month after final prosthesis delivery and after 5,10 and 15 years follow up.

Study Arms (2)

Immediately loading

EXPERIMENTAL

Implants will be loaded with temporary prosthesis immediatelly after their insertion

Device: Immediate implant loading

Early loading

ACTIVE COMPARATOR

Implants will be left to heal with healing abutments for 6 weeks without prosthesis

Device: Early loading

Interventions

Immediate implant loading DEVICE

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.

Also known as: Test group

Immediately loading

Early loading DEVICE

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).

Also known as: Control group

Early loading

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in good general health with no current history of systemic disease or medication use that could interfere with the treatment;
• Patients with complete maxillary edentulism who had lost their teeth at least 6 to 8 weeks prior to the proposed ''allon- six'' implant rehabilitation; and
• Clinically compliant patients consenting to be enrolled into the study.

You may not qualify if:

• Active or chronic disease that affects bone metabolism or wound healing;
• Diminished mental capacities that could mitigate the ability to comply with the protocol;
• Residual roots or teeth;
• History of maxillary augmentation;
• Oral carcinoma or inflammatory changes; and
• History of head and neck radiotherapy.

Sponsors & Collaborators

• University of Belgrade: lead
• Institute Straumann AG, Basel, Switzerland: collaborator

Study Sites (1)

Implant Center, School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (1)

• Markovic A, Misic T, Janjic B, Scepanovic M, Trifkovic B, Ilic B, Todorovic AM, Markovic J, Dard MM. Immediate Vs Early Loading of Bone Level Tapered Dental Implants With Hydrophilic Surface in Rehabilitation of Fully Edentulous Maxilla: Clinical and Patient Centered Outcomes. J Oral Implantol. 2022 Oct 1;48(5):358-369. doi: 10.1563/aaid-joi-D-21-00045.

  PMID: 34937085 RESULT

MeSH Terms

Conditions

Tooth Loss

Interventions

Immediate Dental Implant Loading; Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DDS, PhD

Model Details: Prospective, single-institution, randomized, controlled clinical trial

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: March 1, 2019
• Primary Completion (Estimated): March 1, 2035
• Study Completion (Estimated): March 1, 2035
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2022-2036
• Access Criteria: The investigators will share analyzed outcomes, surgical and prosthetic protocols.

Locations

SE (1)