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Use of 3D printers to help create bone in defects in the upper jaw.

Guided bone regeneration defects using custom 3D scaffolds printed with different biomaterial - Not applicable Not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9wqkr5c
Enrollment
Unknown
Registered
2020-12-16
Start date
2020-09-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Loss

Interventions

In 15 defects in alveolar bone, the regenerative capacity of the alveolar bone will be analyzed with the help of biomaterial scaffolds printed in 3D The parameters will be analyzed in 3 periods (in su
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Sponsors

Federico Henriquez y Carvajal University
Lead Sponsor

Eligibility

Age
21 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a small bone defect in the upper jaw that must be regenerated before dental implants are placed; ASA I or II patients; patients over 21 years of age; patients with good oral hygiene

Exclusion criteria

Exclusion criteria: Systemic alterations; infection in the area of regeneration; patients with chemotherapy or radiotherapy treatment; patients who smoke; patients with systemic diseases; pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Expected primary outcome 1- Bone formation. In the bone volume comparison between the initial CBCT (before surgery) and the final one (4 months after scaffolding). Positive values are expected both in % and in millimetres of mineralised tissue. ;Expected primary outcome 2- Evaluation of the bone neoformation Biopsies of the regenerated area will be taken (4 months after the placement of the scaffolding) and then a histomorphometric examination will be performed to assess the presence or not of neoformed bone tissue. It is expected that the presence of neoformed tissue will be around 15%-30%.

Secondary

MeasureTime frame
Expected secondary outcome 1- Neoformed bone ensures quality for the placement of dental implants. The primary stability of dental implants (placed 4 months after scaffolding) will be measured by means of resonance frequency analysis. It will be measured on the day of the surgery for the placement of the implants. Any ISQ value above 60 will be given as a positive result.;Expected secondary outcome 2-Bone formation. In the bone volume comparison between 4 months CBCT and 8 months CBCT. It is expected that the placement of the implants at 4 months will not affect the bone formation. Positive values are expected both in % and in millimetres of mineralised tissue. ;Secondary expected outcome 3- The neoformed bone ensures the quality for the survival of the dental implants. To evaluate the secondary stability of dental implants by means of resonance frequency analysis. It will be measured 4 months after the placement of the implants which is 8 months after the placement of the scaffolding. Any ISQ value above 60 will be given as a positive result.

Countries

Dominican Republic

Contacts

Public ContactAna Suarez

Universidad Europea de Madrid

ana.suarez@universidadeuropea.es+34-654691012

Outcome results

None listed

Source: REBEC (via WHO ICTRP)