Evaluation Of The Success Rate of NOVAMag® SHIELD (NOVASHIELD-RCT)

April 16, 2026 updated by: Egas Moniz - Cooperativa de Ensino Superior, CRL

Evaluation Of The Success Rate of NOVAMag® SHIELD In Two Different Advanced Bone Defects: A Randomized Controlled Trial

This study hypothesizes that the SHIELD technique, when combined with a suitable bone graft material, enables successful immediate implant placement in Type 3 extraction sockets with buccal bone dehiscence, regardless of the extent of buccal bone loss. Specifically, it is proposed that the regenerative potential of the SHIELD technique is not significantly affected by the degree of buccal bone dehiscence, whether in compromised sockets (ST3 Subclass B, when a buccal dehiscence is present and extending 1/3 to 2/3 of the total length of the alveolus) or severely compromised sockets (ST3 Subclass C, for severe dehiscence passing more than 2/3 of the facial bone of the alveolus). All in all, this study aims to assess the clinical performance of the CE-approved medical device NOVAMag® SHIELD by evaluating its success rate and long-term suitability for the rehabilitation of edentulous regions in routine clinical settings. It further seeks to generate clinically meaningful evidence supporting the safety and efficacy of magnesium-based biomaterials in the management of complex post-extraction defects. In addition, the study investigates the CE-approved self-tapping conical implant VEGA® + to obtain comprehensive clinical data contributing to post-market surveillance and continuous product evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, controlled observational clinical study aims to evaluate the clinical and radiographic outcomes of bone regeneration using the SHIELD Technique with the NOVAMag® membrane XS (SHIELD) in 40 patients of the periodontology department requiring regenerative treatment in the aesthetic region.

Patients will be stratified into two groups of 20 individuals each, based on the condition of the extraction socket. The first group will include compromised sockets classified as ST3 Subclass B, in which a buccal dehiscence extends from one-third to two-thirds of the total length of the alveolus, while the second group will comprise severely compromised sockets classified as ST3 Subclass C, in which the dehiscence extends over two-thirds of the facial bone of the alveolus.

In both groups, cerabone plus (a bovine bone substitute mixed with hyaluronic acid) will be used as the grafting material. In all patients, the CE-approved self-tapping conical implant VEGA® + will be immediately placed, allowing the study to obtain comprehensive clinical data contributing to post-market surveillance and continuous product evaluation.

All procedures will adhere to established ethical standards, including data protection (all patient data will be anonymized prior to collection to ensure confidentiality), informed consent, and rigorous clinical follow-up, ensuring that the study provides reliable and clinically relevant evidence on the performance of magnesium-based membranes in the management of complex post-extraction defects, as well as the clinical performance of immediately placed VEGA® + implants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Portugal
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2829-511
        • Recruiting
        • Clinica Dentária Egas Moniz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older;
  • Willingness and ability to provide informed consent and accept participation in the study.
  • Presence of a tooth indicated for extraction in the aesthetic zone (including premolars);
  • Clinical indication for immediate implant placement following tooth extraction;
  • Extraction sockets classified as Socket Type 3 (ST3), Subclass B or C, according to the Steigmann (2022) classification;

Exclusion Criteria:

  • Pregnancy or lactating women;
  • Systemic diseases or conditions known to affect bone metabolism (osteoporosis, uncontrolled diabetes, metabolic bone disorders, chronic corticosteroid therapy, etc.);
  • Active infection at the surgical site, including the presence of an acute abscess or other signs of ongoing local infection;
  • Hypersensitivity to the biomaterials intended for use in the regenerative procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: First group will include compromised sockets classified as ST3 Subclass B
The first group will include compromised sockets classified as ST3 Subclass B, in which a buccal dehiscence extends from one-third to two-thirds of the total length of the alveolus
Procedure: SHIELD technique with NOVAMag membrane
The SHIELD technique with NOVAMag membrane will be performed and cerabone plus (a bovine bone substitute mixed with hyaluronic acid) will be used as the grafting material. In all patients, the CE-approved self-tapping conical implant VEGA® + will be immediately placed, allowing the study to obtain comprehensive clinical data contributing to post-market surveillance and continuous product evaluation.
Active Comparator: Second group will include compromised sockets classified as ST3 Subclass C
The second group will comprise severely compromised sockets classified as ST3 Subclass C, in which the dehiscence extends over two-thirds of the facial bone of the alveolus.
Procedure: SHIELD technique with NOVAMag membrane
The SHIELD technique with NOVAMag membrane will be performed and cerabone plus (a bovine bone substitute mixed with hyaluronic acid) will be used as the grafting material. In all patients, the CE-approved self-tapping conical implant VEGA® + will be immediately placed, allowing the study to obtain comprehensive clinical data contributing to post-market surveillance and continuous product evaluation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volumetric bone gain
Time Frame: From enrollment to the follow-up consultation at 3 to 4 months
The primary outcome of the study will be volumetric bone gain assessed via CBCT from baseline to the 3-4 month follow-up, while secondary outcomes will include membrane handling characteristics, resorption profile, soft tissue healing, and patient-reported outcomes.
From enrollment to the follow-up consultation at 3 to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Egas Moniz - Cooperativa de Ensino Superior, CRL

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Klockner Implant System
Botiss Biomaterials GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrícia Lyra, PhD, Egas Moniz School of Health & Science
  • Principal Investigator: João Botelho, PhD, Egas Moniz School of Health & Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical and regulatory reasons IPD won't be possible

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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