Evaluation of the Safety and Performance of the Neocement® Inject P: A Prospective Observational Study in Dental Area

NCT07179510 | Recruiting

• 1 other identifier: NeoInjDent01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® Inject P when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation.

Conditions

Bone Augmentation

Keywords

prospective observational clinical study; bone substitute; bone defects; real-world clinical data; safety; performance; medical device; reconstructive dental surgeries; Neocement® Inject P; calcium phosphates

Outcome Measures

Primary Outcomes (3)

• Clinical and radiographic performance endpoint:

  \- Bone gain (augmentation volume in mm³) at 6 months, assessed by computed tomography (CBCT);

  6 months

• Clinical and radiographic performance endpoint:

  \- Bone regeneration at the surgical site, clinically viable for implant placement at 6 months (Yes/No), defined as sufficient bone volume and quality, based on clinical evaluation and CBCT, allowing safe implant placement;

  6 months

• Safety Endpoint

  The assessment of adverse events (AE) and device deficiencies (DD) during the patient follow-up period relation to the medical device. This endpoint will be evaluated at each follow-up visit.

  Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days)

Secondary Outcomes (5)

• Technical success rate

  moment after surgery

• Quality of life assessment

  Visit 1 (before surgery - baseline and enrolment), Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days).

• Radiographic bone density assessment

  6 months

• Pain level assessment

  Visit 1 (before surgery - baseline and enrolment), Visit 2 (moment after surgery), Visit 3 (7 ± 1 days), Visit 4 (6 months ±3 weeks), Visit 5 (12 months ±30 days) and Visit 6 (23 months ±30 days).

• Bone volume variation (in %) assessment

  6 motnhs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The clinical study population consists of adult patients (aged \> 18 years old) who undergo reconstructive dental surgery using the Neocement® Inject P medical device.

You may qualify if:

• Adult males or females (age \> 18 years old);
• Patients who are able to sign an informed consent form (for data collection);
• Patients undergoing reconstructive dental surgery and indicated for the use of Neocement® Inject P;

You may not qualify if:

• Patients who are unable to understand consent and the objectives of the study;
• Signs of local or systemic acute/ active or chronic infections;
• Metabolic affections;
• Severe degenerative diseases, conditions in which general bone grafting is not advisable;
• Implementation sites that allow product migration;
• Conditions which require structural support in the skeletal system;
• Conditions where the implantation site is unstable and not rigidly fixated;
• Sensibility to the implantable materials;
• Known hypersensitivity to the implant material.

Sponsors & Collaborators

• Bioceramed: lead
• Egas Moniz - Cooperativa de Ensino Superior, CRL: collaborator

Study Sites (1)

Egas Moniz School of Health and Science

Lisbon, Portugal

RECRUITING

Study Officials

• João Botelho

  Egas Moniz School of Health and Science Caparica, Lisboa, Portugal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Barros

CONTACT

253 573 460; info@bioceramed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 17, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)