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

NCT07533110 | Recruiting Phase 4

• 1 other identifier: 1793
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alveolar Buccal Bone Dehiscences; Socket Type 3 Subclass B; Socket Type 3 Subclass C

Keywords

Buccal Bone Dehiscence; Magnesium Membrane; Immediate Implant Placement; Socket Shield Technique

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the follow-up consultation at 3 to 4 months

Study Arms (2)

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

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.

Procedure: SHIELD technique with NOVAMag membrane

Interventions

SHIELD technique with NOVAMag membrane PROCEDURE

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.

First group will include compromised sockets classified as ST3 Subclass B; Second group will include compromised sockets classified as ST3 Subclass C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• Botiss Biomaterials GmbH: collaborator
• Klockner Implant System: collaborator

Study Sites (1)

Clinica Dentaria Egas Moniz

Almada, Setúbal District, 2829-511, Portugal

RECRUITING

Study Officials

• Patrícia Lyra, PhD

  Egas Moniz School of Health & Science

  PRINCIPAL INVESTIGATOR

• João Botelho, PhD

  Egas Moniz School of Health & Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrícia Lyra, PhD

CONTACT

212 946 700; plyra@egasmoniz.edu.pt

João Botelho, PhD

CONTACT

212 946 700; jbotelho@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)