E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

NCT06627621 | Completed Early Phase 1

• 1 other identifier: 2023/20
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Grafting

Keywords

alveolar ridge augmentation, alveolar bone loss, dental implant, guided tissue regeneration, polycaprolactone

Outcome Measures

Primary Outcomes (1)

• Shapiro-Wilk test

  Descriptive statistics are presented as median, mean, standard deviation, minimum-maximum, standard error, and frequency values

  From enrollment to the end of treatment at 6 months

Study Arms (1)

Alveolar bone grafting

OTHER

Scaffold guided bone regeneration

Procedure: Alveolar Ridge Reconstruction

Interventions

Alveolar Ridge Reconstruction PROCEDURE

scaffold guided alveolar bone regeneration

Alveolar bone grafting

Eligibility Criteria

• Age: 18 Months - 80 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• cem üngör: lead

Study Sites (1)

Karadeniz Technical University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Trabzon, Trabzon, 61100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr Cem UNGOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: March 8, 2021
• Primary Completion: January 8, 2023
• Study Completion: January 8, 2023
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

TU (1)