Alveolar Bone GraftingEarly Phase 1NCT06627621
E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration
A Early Phase 1 study testing Alveolar Ridge Reconstruction in people with Alveolar Bone Grafting, run by cem üngör at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 monthsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Grafting
- What is being tested?
- Alveolar Ridge Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 8 Jan 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Trabzon, Trabzon, 61100
About this study
Official title: EVALUATION of the EFFICACY of E-POLYCAPROLACTONE-CONTAINING MEMBRANE in ALVEOLAR BONE REGENERATION: a RETROSPECTIVE STUDY
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
- Being tested
- Alveolar Ridge Reconstruction
- Keywords
- alveolar ridge augmentation, alveolar bone loss, dental implant, guided tissue regeneration, polycaprolactone
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge ReconstructionProcedure or surgery
scaffold guided alveolar bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| Alveolar bone grafting | Other | Scaffold guided bone regeneration Receives: Procedure: Alveolar Ridge Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shapiro-Wilk test
Descriptive statistics are presented as median, mean, standard deviation, minimum-maximum, standard error, and frequency values
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start8 Mar 2021
- Primary completion8 Jan 2023
- Study completion8 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- cem üngör
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, cem üngör, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627621
- Sponsor's protocol ID
- 2023/20
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION of the EFFICACY of E-POLYCAPROLACTONE-CONTAINING MEMBRANE in ALVEOLAR BONE REGENERATION: a RETROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT06627621
- Acronym / sponsor ID
- 2023/20
- Conditions
- Alveolar Bone Grafting
- Keywords
- alveolar ridge augmentation, alveolar bone loss, dental implant, guided tissue regeneration, polycaprolactone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- cem üngörUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 8 Jan 2023 (actual)
- Study completion
- 8 Jan 2023 (actual)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alveolar bone grafting | Other | Procedure: Alveolar Ridge ReconstructionScaffold guided bone regeneration |
Who may qualify
- Ages
- 18 to 80 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar Ridge Reconstructionscaffold guided alveolar bone regeneration | Procedure or surgery | Alveolar bone grafting |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alveolar Ridge Reconstruction in people with Alveolar Bone Grafting, run by cem üngör at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shapiro-Wilk test (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.