Post-Extraction Socket HealingNCT06621498
Ridge Preservation Using Guided Regenaration, Platelet-rich Plasma and Free Gingival Grafts
A study testing Ridge preservation technique and ridge preservation in people with Post-Extraction Socket Healing and Ridge Preservation, run by Medical University of Varna at 1 site in Bulgaria.
Trial summary
The goal of this clinical trial is to learn if ridge preservation methods with dense polytetrafluoroethylene membranes, with d-PTFE membranes and platelet-rich plasma, and with free gingival grafts can reduce vertical resorption of the post-extraction socket walls. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Extraction Socket Healing, Ridge Preservation
- What is being tested?
- Ridge preservation technique and ridge preservation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBulgaria
- Study dates
- 23 Jun 2022to 12 Apr 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
- Patients in the age group 18-65 years;
- Patients in good general condition;
- Patients requiring extraction of premolars or molars;
- Patients in whom restoration of the missing tooth with a dental implant and/or prosthetic construction is planned;
- Signed informed consent to participate in the study.
Who cannot join
- Patients with contraindications for general surgical treatment:
- patients with uncontrolled arterial hypertension;
- patients with uncontrolled metabolic diseases;
- patients with AMI in the last 6 months;
- patients on hemodialysis treatment;
- patients who underwent chemotherapy and/or radiotherapy in the last year;
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- patients on immunosuppressive therapy;
- patients on anti-resorptive and anti-angiogenic therapy;
- patients with concomitant acute diseases at the time of the study;
- patients with proven psychiatric diseases;
- pregnancy.
- There are local contraindications:
- insufficient volume of bone after the extraction to carry out RP;
- acute inflammatory disease or tumor process in the area;
- Lack of informed consent.
- Lack of patient motivation for the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if ridge preservation methods with dense polytetrafluoroethylene membranes, with d-PTFE membranes and platelet-rich plasma, and with free gingival grafts can reduce vertical resorption of the post-extraction socket walls.
Researchers compared each experimental group to a control group (unassisted socket healing). Participants were randomly allocated to one of the four groups.
Cone-beam computed tomography was performed after the procedure and 3 months post-operatively to evaluate the vertical socket wall resorption.
- Conditions
- Post-Extraction Socket Healing, Ridge Preservation
- Being tested
- Ridge preservation technique, ridge preservation
- Keywords
- ridge preservation, post-extraction healing, post-extraction resorption, dense polytetrafluoroethylene membrane, free gingival graft, platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge preservation techniqueProcedure or surgery
Also called ridge preservation, socket preservation
Tooth extraction, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.
ridge preservationProcedure or surgery
Also called socket preservation
Tooth extraction, socket filling with PRP, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing.
ridge preservationProcedure or surgery
Also called socket preservation
Tooth extraction, full-thickness graft harversting and socket sealing with it.
| Study group | Role | What they receive |
|---|---|---|
| Ridge preservation with dense polytetrafluoroethylene membrane | Experimental | Tooth extraction and ridge prservation with dense PTFE membrane to cover the socket was used in this group. Receives: Procedure: Ridge preservation technique |
| Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma | Experimental | Tooth extraction and ridge prservation with dense PTFE membrane and autologous PRP was used in this group. Receives: Procedure: ridge preservation |
| Ridge preservation with free gingival grafts | Experimental | Tooth extraction and ridge prservation with autologous free gingival grafts as a method for socket sealing was used. Donor sites were the hard palate and the maxillary tuberosity. Receives: Procedure: ridge preservation |
| Control group | No intervention | Tooth extraction without ridge preservation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical post-extraction resorption of the socket walls
Each socket wall is measured using CBCT right after the extraction and after 3 months to assess the vertical resorption.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start23 Jun 2022
- Primary completion20 Mar 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Extraction Socket HealingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Varna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralitsa Yotsova, Medical University of Varna
- Investigators
- Stefan V Peev, DsC, Principal investigator, Medical University of Varna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621498
- Sponsor's protocol ID
- 118/23.06.2022
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has not been approved by the Research Ethics Committee
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation Using Guided Regenaration, Platelet-rich Plasma and Free Gingival Grafts
- ClinicalTrials.gov ID
- NCT06621498
- Acronym / sponsor ID
- 118/23.06.2022
- Conditions
- Post-Extraction Socket Healing, Ridge Preservation
- Keywords
- ridge preservation, post-extraction healing, post-extraction resorption, dense polytetrafluoroethylene membrane, free gingival graft, platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of VarnaUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 1 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.
The goal of this clinical trial is to learn if ridge preservation methods with dense polytetrafluoroethylene membranes, with d-PTFE membranes and platelet-rich plasma, and with free gingival grafts can reduce vertical resorption of the post-extraction socket walls.
Researchers compared each experimental group to a control group (unassisted socket healing). Participants were randomly allocated to one of the four groups.
Cone-beam computed tomography was performed after the procedure and 3 months post-operatively to evaluate the vertical socket wall resorption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ridge preservation with dense polytetrafluoroethylene membrane | Experimental | Procedure: Ridge preservation techniqueTooth extraction and ridge prservation with dense PTFE membrane to cover the socket was used in this group. |
| Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma | Experimental | Procedure: ridge preservationTooth extraction and ridge prservation with dense PTFE membrane and autologous PRP was used in this group. |
| Ridge preservation with free gingival grafts | Experimental | Procedure: ridge preservationTooth extraction and ridge prservation with autologous free gingival grafts as a method for socket sealing was used. Donor sites were the hard palate and the maxillary tuberosity. |
| Control group | No intervention | –Tooth extraction without ridge preservation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in the age group 18-65 years;
- Patients in good general condition;
- Patients requiring extraction of premolars or molars;
- Patients in whom restoration of the missing tooth with a dental implant and/or prosthetic construction is planned;
- Signed informed consent to participate in the study.
Key exclusion criteria (16 listed)
- Patients with contraindications for general surgical treatment:
- There are local contraindications:
- Lack of informed consent.
- Lack of patient motivation for the treatment.
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 |
|---|---|---|
| Ridge preservation techniqueAlso: ridge preservation, socket preservationTooth extraction, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing. | Procedure or surgery | Ridge preservation with dense polytetrafluoroethylene membrane |
| ridge preservationAlso: socket preservationTooth extraction, socket filling with PRP, deperiostation of the buccal and oral marginal gingiva, placement of d-PTFE membranes and suturing. | Procedure or surgery | Ridge preservation with dense polytetrafluoroethylene membrane and platelet-rich plasma |
| ridge preservationAlso: socket preservationTooth extraction, full-thickness graft harversting and socket sealing with it. | Procedure or surgery | Ridge preservation with free gingival grafts |
Primary outcome
Vertical post-extraction resorption of the socket walls
Time frame: 3 months
Each socket wall is measured using CBCT right after the extraction and after 3 months to assess the vertical resorption.
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 1 Oct 2024.
- Individual participant dataSharing planned: No. It has not been approved by the Research Ethics Committee
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Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
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Autologous Platelet Concentrates on the Healing of Extraction Sockets
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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.
Stefan V Peev, DsC principal investigator
Medical University of Varna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge preservation technique and ridge preservation in people with Post-Extraction Socket Healing and Ridge Preservation, run by Medical University of Varna 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 5 inclusion and 16 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 1 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?
Vertical post-extraction resorption of the socket walls (time frame: 3 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 1 Oct 2024.