NCT06627621CompletedPhase 1
EVALUATION of the EFFICACY of E-POLYCAPROLACTONE-CONTAINING MEMBRANE in ALVEOLAR BONE REGENERATION: a RETROSPECTIVE STUDY
cem üngör1 site in 1 country4 target enrollmentStarted: March 8, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Shapiro-Wilk test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to 80 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Alveolar bone grafting
Other
Scaffold guided bone regeneration
Intervention: Alveolar Ridge Reconstruction (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
cem üngör
Professor Dr Cem UNGOR
Karadeniz Technical University
Study Sites (1)
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