E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

Early Phase 1

Completed

• Conditions: Alveolar Bone Grafting
• Interventions: Procedure: Alveolar Ridge Reconstruction

• Registration Number: NCT06627621
• Lead Sponsor: cem üngör

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Primary Completion: 2023-01-08
• Study Completion: 2023-01-08
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alveolar bone grafting	Alveolar Ridge Reconstruction	Scaffold guided bone regeneration

Primary Outcome Measures

Name	Time	Method
Shapiro-Wilk test	From enrollment to the end of treatment at 6 months	Descriptive statistics are presented as median, mean, standard deviation, minimum-maximum, standard error, and frequency values

Trial Locations

Locations (1)

Karadeniz Technical University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery; 🇹🇷 Trabzon, Turkey