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MaxillaNCT07574099

Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla

A study testing Immediate implant loading and Early loading in people with Maxilla and Tooth Loss / Rehabilitation, run by University of Belgrade at 1 site in Serbia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Maxilla, Tooth Loss / Rehabilitation
What is being tested?
Immediate implant loading and Early loading
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSerbia
Study dates
1 Mar 2019to Mar 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Serbia1 site
  • Implant Center, School of Dental Medicine, University of Belgrade

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: Immediate Vs Early Loading Protocols in Rehabilitation of Healed Fully Edentulous Maxilla

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:

Read more
  • 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
Read the detailed description

Surgical protocol Prior to surgery antibiotic prophylaxis (2 g amoxicillin with clavulonic acid or, in case of allergy, 0.6 g clindamycin, 1 hour before the procedure) and antiedema therapy (0.004 g dexamethasone 1 hour before the procedure) was administered. Patients rinsed their mouth using 15 mL of 0.12% chlorhexidine solution for 1 minute preoperatively. The surgical procedures were performed under local anesthesia using 4% articaine, 1:100.000 epinephrine. Centers of the intended implant sites were marked according to the reference marks present in the patient's existing complete removable denture that had been used as the radiographic stent. A midcrestal incision was made, then full-thickness buccal and palatal flaps were elevated. Implant sites were prepared by strictly adhering to the manufacturer's protocol for low-density bone using drills of increasing diameter (Institut Straumann). To provide adequate primary implant stability, underpreparation was performed: 1. In low-density type D3 bone, the profile drill was skipped; and 2. In low-density type D4 bone, the final sequence and profile drills were skipped. Intermittent drilling under copious irrigation was performed with low hand pressure and a physiodispenser running between 600 and 800 rpm. A total of 144 sites were prepared, followed by placement of 144 SLActive surface (Bone Level Tapered, Institut Straumann) implants. Bone quality was assessed according to the Lekholm and Zarb classification. In sites with dehiscence or fenestration resulting in an exposed implant surface, localized bone augmentation was performed using bovine-derived xenograft (Geistlich Bio-Oss, Geistlich, Wolhusen, Switzerland) and covered with a type 1 collagen membrane (Geistlich Bio-Gide, Geistlich). Healing screws (Institut Straumann; NC healing abutment Ø4.8 mm conical 5 mm and RC healing abutment Ø5 mm conical 6 mm) were placed and primary wound closure was achieved with 5-0 single resorbable sutures (AssuCryl Lactin, Assut Sutures of Switzerland, Pully-Lausanne, Switzerland). Patients were discharged with recommendations regarding dietetic and hygienic regimens. Antibiotic protocol consisted of 2 g amoxicillin with clavulonic acid (divided into 2 doses) or, in case of allergy, 1.8 g clindamycin daily (divided into 3 doses) for the following 5 days. Antiedema therapy (0.004 g dexamethasone) was administered 24 hours postoperatively. Prosthetic protocol After dental implant placement, patients were randomly assigned to immediate loading or early loading groups.

Implants for patients from Test Group were immediately loaded using S-R abutments (Institut Straumann) with temporary restorations. Patients from Control Group did not receive any kind of prosthetic temporization and were left with healing abutments. For Test Group an open-tray impression technique was used for provisional restoration. Impressions were made using: ASilicone material (Hydrorise implant, Zhermack, Badia Polesine, Italy), splinted impression posts (RC and NC impression post, Straumann) and a plastic impression tray (Miratray, Hager Werken, Duisburg, Germany). 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). The following final Straumann screw retained abutments for the prosthetic bridge (Institut Straumann) were chosen according to implant angulation and surrounding soft tissue height. For the interface between the screw-retained abutments and final prosthetic work, copings for screw retained abutments (Institut Straumann) were used and bonded to the final prosthesis.

At the end of the 6-week healing period for both groups, 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).

Being tested
Immediate implant loading, Early loading
Keywords
edentulous maxilla, dental implant, implant loading protocol, complete implant-supported fixed dental prostheses
Medical subject headings
Tooth Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate implant loadingDevice

    Also called Test group

    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.

  • Early loadingDevice

    Also called Control group

    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).

Study groups in NCT07574099
Study groupRoleWhat they receive
Immediately loadingExperimentalImplants will be loaded with temporary prosthesis immediatelly after their insertion
Receives: Device: Immediate implant loading
Early loadingActive comparatorImplants will be left to heal with healing abutments for 6 weeks without prosthesis
Receives: Device: Early loading

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Insertion torque

    Insertion torque was measured with a torque wrench (Institut Straumann) and recorded in Ncm.

    Measured: During surgery, at implant placement in prepared implant site.

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

    Following prosthesis and multiunit abutment removal, standardized healing abutments (identical to baseline protocol) were placed. CBCT images were acquired at the same exposure parameters as baseline and analyzed by one blinded examiner using OnDemand3D software (Cybermed Inc., Seoul, South Korea). MBL was measured as the linear distance from the implant shoulder to first bone-implant contact at four sites per implant: mesial, distal, buccal, and palatal aspects.

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

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

    Following prosthesis and multiunit abutment removal, standardized healing abutments (identical to baseline protocol) were placed. CBCT images were acquired at the same exposure parameters as baseline and analyzed by one blinded examiner using OnDemand3D software (Cybermed Inc., Seoul, South Korea). BPT was measured perpendicular to the implant axis at two locations: 2 mm apical to the implant-abutment connection and at implant midlength.

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

  4. Oral health-related quality of life

    Oral health-related quality of life was evaluated using the OHIP-19 questionnaire. It consists of 19 questions and patients rated each item on a 5-point scale, where 0 indicated "never" and 4 indicated "constantly." The total OHIP-19 score was obtained by summing the scores from all questions. Lower score meant improved quality of life.

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

  5. Patient satisfaction

    Patients specified their level of satisfaction related to function, esthetics, and discomfort/pain by indicating a position along a 10-cm line between 2 endpoints where the beginning of the line was marked as complete unsatisfaction and the end as maximum satisfaction on Visual Analogue Scale.

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

  6. Implant survival rate

    Implant survival was defined as implant in situ regardless of condition or peri-implant disease presence.

    Measured: 1 month after final prosthesis delivery, after 5, 10 and 15 years follow up

  7. Prosthesis survival rate

    Prosthesis survival was defined as original prosthesis in function with or without minor repairs.

    Measured: 1 month after final prosthesis delivery, after 5, 10 and 15 years follow up

  8. Complications

    Biological complications (implant failure requiring removal, peri-implantitis, peri-implant mucositis) and mechanical complications (prosthesis fracture, veneer chipping, screw loosening/fracture, abutment complications) were recorded.

    Measured: 1 month after final prosthesis delivery, after 5, 10 and 15 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start1 Mar 2019
  3. Primary completionMar 2035 (estimated)
  4. Study completionMar 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, single-institution, randomized, controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574099
Sponsor's protocol ID
16/36
Status last verified
May 2026
First submitted
1 May 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 1 month, 5 years, 10 years and 15 years outcomes will be published in the journal.

Publications

  • 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.

    PubMed 34937085
  • Uysal VMB, Markovic A, Misic T, Scepanovic M, Trifkovic B, Ilic B, Todorovic AR, Markovic J, Dard MM, Janjic B. Immediate Versus Early Loading Protocols in Rehabilitation of Fully Edentulous Maxilla: A 5-Year Pilot Randomized Clinical Trial. J Oral Rehabil. 2026 Oct 2. doi: 10.1111/joor.70330. Online ahead of print.

    PubMed 42827082

Questions about this trial

What is this clinical trial studying?

A study testing Immediate implant loading and Early loading in people with Maxilla and Tooth Loss / Rehabilitation, run by University of Belgrade at 1 site in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant stability (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07574099, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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