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E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

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Status and phase

Completed
Early Phase 1

Conditions

Alveolar Bone Grafting

Treatments

Procedure: Alveolar Ridge Reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT06627621
2023/20

Details and patient eligibility

About

This study aimed to evaluate the effectiveness of synthetic polycaprolactone (PCL) bioscaffold membranes used for alveolar augmentation in maxillofacial surgery for increasing the amount of newly formed bone after three-dimensional application.

Enrollment

4 patients

Sex

All

Ages

18 to 80 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • (1) patients aged >18 years without any systemic disease or with an established systemic disease that precluded the surgical procedure; (2) patients whose bone deficiency was augmented with PCL scaffolds; (3) patients with an indication for dental implant-supported prosthesis who lacked sufficient bone for dental implants according to cone beam computed tomography (CBCT) evaluation and, therefore, needed bone augmentation; and (4) patients with preoperative and postoperative images.

Exclusion criteria

  • patients (1) with uncontrolled systemic diseases, (2) who had undergone radiation therapy, (3) who were female and pregnant, (4) who had previously undergone any surgical procedure related to augmentation in the area of the defect, (5) who had incomplete files or lacked pre- and post-treatment radiologic records, or (6) who had psychological problems.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Alveolar bone grafting
Other group
Description:
Scaffold guided bone regeneration
Treatment:
Procedure: Alveolar Ridge Reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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