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Completed

NCT Number: NCT06627621

E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

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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Key information

Conditions

Alveolar Bone Grafting Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 month–80 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Trabzon, 61100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alveolar Ridge Reconstruction

Procedure

scaffold guided alveolar bone regeneration

Primary outcomes

  1. Shapiro-Wilk test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

cem üngör

Other

Registry information

Official study title

EVALUATION of the EFFICACY of E-POLYCAPROLACTONE-CONTAINING MEMBRANE in ALVEOLAR BONE REGENERATION: a RETROSPECTIVE STUDY

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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