NOVAMag SHIELD for immediate implants in sockets with buccal bone loss
Official title: Evaluation Of The Success Rate of NOVAMag® SHIELD In Two Different Advanced Bone Defects: A Randomized Controlled Trial
Run by Egas Moniz - Cooperativa de Ensino Superior, CRL · NCT07533110 · Data updated 2026-11-12
This trial sees if NOVAMag SHIELD plus a bone graft helps adults with Type 3 extraction sockets and buccal bone dehiscence receive immediate dental implants successfully.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Egas Moniz - Cooperativa de Ensino Superior, CRL Academic / other |
| Locations | 1 site (Almada, Setúbal District) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | December 18, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07533110 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a tooth in the aesthetic zone indicated for extraction and immediate implant placement and an extraction socket classified as ST3 Subclass B or C are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have systemic bone metabolism disorders, active local infection, hypersensitivity to the materials, or sockets that are not ST3 are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, controlled observational study will enroll 40 adults needing regenerative treatment in the aesthetic region and stratify them into two groups of 20 based on socket classification (ST3 Subclass B or C). All participants will receive immediate placement of a CE‑approved VEGA® + implant, grafting with cerabone plus mixed with hyaluronic acid, and coverage with the NOVAMag® SHIELD magnesium membrane using the SHIELD technique. Clinical and radiographic outcomes including implant success, bone regeneration, and long‑term suitability for rehabilitation will be recorded to contribute to post‑market surveillance. The protocol includes informed consent, anonymized data handling, and scheduled follow‑up visits to capture safety and performance in routine clinical practice.
Why it matters
Potential benefit: If successful, the approach could allow immediate implant placement in sockets with moderate to severe buccal bone loss, helping preserve esthetics and simplifying rehabilitation.
How similar studies have gone: Early case series and preclinical data support socket‑shield approaches and resorbable magnesium membranes, but large controlled clinical evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Clinica Dentaria Egas Moniz
Almada, Setúbal District, Portugal Recruiting
Study contacts
- Principal investigator: Patrícia Lyra, PhD — Egas Moniz School of Health & Science
- Study coordinator: Patrícia Lyra, PhD
- Email: plyra@egasmoniz.edu.pt
- Phone: 212 946 700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.