E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2023-01-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Alveolar Bone Grafting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alveolar bone grafting

Scaffold guided bone regeneration

Group Type OTHER

Alveolar Ridge Reconstruction

Intervention Type PROCEDURE

scaffold guided alveolar bone regeneration

Interventions

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Alveolar Ridge Reconstruction

scaffold guided alveolar bone regeneration

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Months

Maximum Eligible Age

80 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes