Alveolar Buccal Bone DehiscencesPhase 4NOVASHIELD-RCTNCT07533110
Evaluation Of The Success Rate of NOVAMag® SHIELD
A Phase 4 study testing SHIELD technique with NOVAMag membrane in people with Alveolar Buccal Bone Dehiscences and Socket Type 3 Subclass B, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alveolar Buccal Bone Dehiscences, Socket Type 3 Subclass B, Socket Type 3 Subclass C
- What is being tested?
- SHIELD technique with NOVAMag membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Mar 2026to 30 Sep 2027
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Clinica Dentaria Egas Moniz
Almada, Setúbal District, 2829-511
Patricia Lyra, PhD, 212946806, plyra@egasmoniz.edu.pt
About this study
Official title: 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.
Read the 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.
- Being tested
- SHIELD technique with NOVAMag membrane
- Keywords
- Buccal Bone Dehiscence, Magnesium Membrane, Immediate Implant Placement, Socket Shield Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIELD technique with NOVAMag membraneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| First group will include compromised sockets classified as ST3 Subclass B | Active comparator | 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 Receives: Procedure: SHIELD technique with NOVAMag membrane |
| Second group will include compromised sockets classified as ST3 Subclass C | Active comparator | 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. Receives: Procedure: SHIELD technique with NOVAMag membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric bone gain
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.
Measured: From enrollment to the follow-up consultation at 3 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start19 Mar 2026
- Primary completion18 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Buccal Bone DehiscencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- Botiss Biomaterials GmbH, Klockner Implant System S.A.
- Responsible party
- Sponsor
- Investigators
- Patrícia Lyra, PhD, Principal investigator, Egas Moniz School of Health & ScienceJoão Botelho, PhD, Principal investigator, Egas Moniz School of Health & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533110
- Sponsor's protocol ID
- 1793
- Acronym
- NOVASHIELD-RCT
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and regulatory reasons IPD won't be possible
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Success Rate of NOVAMag® SHIELD In Two Different Advanced Bone Defects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07533110
- Acronym / sponsor ID
- NOVASHIELD-RCT / 1793
- Keywords
- Buccal Bone Dehiscence, Magnesium Membrane, Immediate Implant Placement, Socket Shield Technique
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- Botiss Biomaterials GmbH, Klockner Implant System S.A.
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group will include compromised sockets classified as ST3 Subclass B | Active comparator | Procedure: SHIELD technique with NOVAMag membraneThe 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 |
| Second group will include compromised sockets classified as ST3 Subclass C | Active comparator | Procedure: SHIELD technique with NOVAMag membraneThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHIELD technique with NOVAMag membraneThe 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. | Procedure or surgery | First group will include compromised sockets classified as ST3 Subclass B, Second group will include compromised sockets classified as ST3 Subclass C |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. Due to ethical and regulatory reasons IPD won't be possible
Related trials for Alveolar Buccal Bone Dehiscences
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrícia Lyra, PhD principal investigator
Egas Moniz School of Health & Science
João Botelho, PhD principal investigator
Egas Moniz School of Health & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SHIELD technique with NOVAMag membrane in people with Alveolar Buccal Bone Dehiscences and Socket Type 3 Subclass B, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Apr 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 Portugal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Patrícia Lyra, PhD (212 946 700, plyra@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric bone gain (time frame: From enrollment to the follow-up consultation at 3 to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.