E-Polycaprolactone-Containing Membrane in Alveolar Bone R... | NCT06627621

Studies
E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

NCT06627621

Sponsor

cem üngör

Status

Completed

Last Update Posted

Oct 4, 2024Actual

Enrollment

4Actual

Phase

Early Phase 1

Conditions

Alveolar Bone Grafting

Interventions

Alveolar Ridge Reconstruction

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2021Actual

Primary Completion Date

Jan 8, 2023Actual

Completion Date

Jan 8, 2023Actual

First Submitted Date

Oct 3, 2024

First Submission Date that Met QC Criteria

Oct 3, 2024

First Posted Date

Oct 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2024

Last Update Posted Date

Oct 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alveolar bone grafting	Other	Scaffold guided bone regeneration	Procedure: Alveolar Ridge Reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alveolar Ridge Reconstruction	Procedure	scaffold guided alveolar bone regeneration	Alveolar bone grafting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

80 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karadeniz Technical University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery		Trabzon	Trabzon	61100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D016301	Alveolar Bone Loss

Ancestor Terms

ID	Term
D001862	Bone Resorption
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D055093	Periodontal Atrophy

Browse Leaves

Not provided

Browse Branches

Not provided