Vertical Alveolar Bone LossNCT06639555
Initial Clinical and CBCT Outcomes of Enamel Matrix Derivative-Based Regenerative Therapy in Vertical Bone Defects
A study testing PRP( platelet rich plasma), EMD (Enamel Matrix Derivative) and Guided Tissue Regeneration (barrier membrane) in people with Vertical Alveolar Bone Loss, run by Tsvetalina Gerova-Vatsova at 1 site in Bulgaria.
Trial summary
Study of the effectiveness of the application of regenerative therapy with autogenous, platelet-rich plasma in vertical defects Investigation of the effectiveness of the application of regenerative therapy with enamel matrix derivatives in vertical bone defects Study of the effectiveness of the application of guided… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vertical Alveolar Bone Loss
- What is being tested?
- PRP( platelet rich plasma), EMD (Enamel Matrix Derivative) and Guided Tissue Regeneration (barrier membrane)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBulgaria
- Study dates
- 24 Jun 2022to 15 Aug 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good oral hygiene
- written informed consent
- age
- no systemic diseases
Who cannot join
- smokers
- horizontal bone loss
- untreated periodontium disease
Trial locations and contacts
1 site in 1 country.
About this study
Study of the effectiveness of the application of regenerative therapy with autogenous, platelet-rich plasma in vertical defects Investigation of the effectiveness of the application of regenerative therapy with enamel matrix derivatives in vertical bone defects Study of the effectiveness of the application of guided tissue regeneration in vertical bone defects with Barrier membrane and Barrier membrane and autogenous platelet-rich plasma
- Conditions
- Vertical Alveolar Bone Loss
- Being tested
- PRP( platelet rich plasma), EMD (Enamel Matrix Derivative), Guided Tissue Regeneration (barrier membrane), Guided Tissue Regeneration(barrier membrane and PRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP( platelet rich plasma)Procedure or surgery
regenerative therapy with PRP for vertical bone defects
EMD (Enamel Matrix Derivative)Procedure or surgery
regenerative therapy with EMD for vertical bone defects
Guided Tissue Regeneration (barrier membrane)Procedure or surgery
guided tissue regeneration with barrier membrane alone for vertical bone defects
Guided Tissue Regeneration(barrier membrane and PRP)Procedure or surgery
guided tissue regeneration with barrier membrane and PRP for vertical bone defects
| Study group | Role | What they receive |
|---|---|---|
| PRP alone | Active comparator | Not described Receives: Procedure: PRP( platelet rich plasma) |
| EMD Alone | Active comparator | Not described Receives: Procedure: EMD (Enamel Matrix Derivative) |
| GTR (barrier membrane) | Active comparator | Not described Receives: Procedure: Guided Tissue Regeneration (barrier membrane) |
| GTR(barrier membrane and PRP) | Active comparator | Not described Receives: Procedure: Guided Tissue Regeneration(barrier membrane and PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth in mm
Measured: 6 months
Level of Margo Gingivalis in mm
Measured: 6 months
Clinical attachment level in mm
Measured: 6 months
The distance from the ECJ to the base of the bone defect in mm
Measured: 6 months
The distance from the ECJ to the apex of the bone defect in mm
Measured: 6 months
The width of the bone defect in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start24 Jun 2022
- Primary completion15 Feb 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertical Alveolar Bone LossStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsvetalina Gerova-Vatsova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tsvetalina Gerova-Vatsova, Medical University of Varna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639555
- Sponsor's protocol ID
- 118/23.06.22
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Clinical and CBCT Outcomes of Enamel Matrix Derivative-Based Regenerative Therapy in Vertical Bone Defects
- ClinicalTrials.gov ID
- NCT06639555
- Acronym / sponsor ID
- 118/23.06.22
- Conditions
- Vertical Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tsvetalina Gerova-VatsovaUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 15 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.
Study of the effectiveness of the application of regenerative therapy with autogenous, platelet-rich plasma in vertical defects Investigation of the effectiveness of the application of regenerative therapy with enamel matrix derivatives in vertical bone defects Study of the effectiveness of the application of guided tissue regeneration in vertical bone defects with Barrier membrane and Barrier membrane and autogenous platelet-rich plasma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRP alone | Active comparator | Procedure: PRP( platelet rich plasma) |
| EMD Alone | Active comparator | Procedure: EMD (Enamel Matrix Derivative) |
| GTR (barrier membrane) | Active comparator | Procedure: Guided Tissue Regeneration (barrier membrane) |
| GTR(barrier membrane and PRP) | Active comparator | Procedure: Guided Tissue Regeneration(barrier membrane and PRP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- good oral hygiene
- written informed consent
- age
- no systemic diseases
Key exclusion criteria (3 listed)
- smokers
- horizontal bone loss
- untreated periodontium disease
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 |
|---|---|---|
| PRP( platelet rich plasma)regenerative therapy with PRP for vertical bone defects | Procedure or surgery | PRP alone |
| EMD (Enamel Matrix Derivative)regenerative therapy with EMD for vertical bone defects | Procedure or surgery | EMD Alone |
| Guided Tissue Regeneration (barrier membrane)guided tissue regeneration with barrier membrane alone for vertical bone defects | Procedure or surgery | GTR (barrier membrane) |
| Guided Tissue Regeneration(barrier membrane and PRP)guided tissue regeneration with barrier membrane and PRP for vertical bone defects | Procedure or surgery | GTR(barrier membrane and PRP) |
Primary outcome
Probing depth in mm
Time frame: 6 months
Level of Margo Gingivalis in mm
Time frame: 6 months
Clinical attachment level in mm
Time frame: 6 months
The distance from the ECJ to the base of the bone defect in mm
Time frame: 6 months
The distance from the ECJ to the apex of the bone defect in mm
Time frame: 6 months
The width of the bone defect in mm
Time frame: 6 months
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 15 Oct 2024.
Related trials for Vertical Alveolar Bone Loss
Active, not recruiting
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
Alveolar Bone Loss, Dental Implant Failed
Not yet recruiting
Novel Synthetic Membrane for Horizontal Bone Augmentation: A Case Series
Alveolar Ridge Deficiency, Alveolar Bone Loss
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
Not yet recruiting
Radiographic and Histomorphometric Assessment for Alveolar Ridge Preservation Using Autogenous Tooth Graft From Extracted Tooth Combined With Simvastatin 1:1 Versus Autogenous Tooth Graft
Alveolar Ridge Preservation, Horizontal Alveolar Bone Loss
Recruiting
Alveolar Cleft Reconstruction With Cortical-Shells
Alveolar Cleft
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 study testing PRP( platelet rich plasma), EMD (Enamel Matrix Derivative) and Guided Tissue Regeneration (barrier membrane) in people with Vertical Alveolar Bone Loss, run by Tsvetalina Gerova-Vatsova at 1 site in Bulgaria.
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 4 inclusion and 3 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 15 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 Bulgaria. 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.
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?
Probing depth in mm (time frame: 6 months). The study lists 6 primary outcomes in all. 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 15 Oct 2024.