Bone RegenerationNCT05791123
Alveolar Ridge Augmentation Following Tooth Extraction Using Bovine Xenograft With Platelet Rich Fibrin Membrane
A study testing a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket in people with Bone Regeneration, run by Future University in Egypt at 1 site in Egypt.
Trial summary
fourteen patients requiring extraction of one posterior tooth with lost buccal bone (>50%) confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2018to 5 Mar 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients required implant treatment after tooth extraction
- Age group ranged from 20-60 years old.
- Patients could undergo the treatment under local anesthesia.
- Loss of buccal bone (>50%) confirmed by preoperative cone beam computed tomography (CBCT).
- Presence of other socket walls; mesial, distal and lingual walls.
- Tooth needed to be extracted in upper or lower posterior regions
Who cannot join
- Uncontrolled diabetic diseases.
- Uncontrolled hypertension, or hepatic and renal disorders.
- Any systemic diseases associated with bone metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
fourteen patients requiring extraction of one posterior tooth with lost buccal bone (>50%) confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. (CBCT) scans, performed before tooth extraction and after 6 months, were used to assess vertical and horizontal bone changes.
- Conditions
- Bone Regeneration
- Being tested
- a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socketProcedure or surgery
Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets.
| Study group | Role | What they receive |
|---|---|---|
| a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket | Experimental | Not described Receives: Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in alveolar bone width and height in mm using CBCT scans.
Cone Beam Computed Tomography were taken for each patients before tooth extraction and after 6 months, which were used to assess alveolar ridge changes in width and length 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 posted30 Mar 2023
- Study start15 Jul 2018
- Primary completion20 Feb 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone RegenerationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Sameh Abdelaziz, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791123
- Sponsor's protocol ID
- REC-FDBSU/05012023-03/ER
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elbanna RM, Abdelaziz MS, Alameldeen HE. Augmentation of single tooth extraction socket with deficient buccal walls using bovine xenograft with platelet-rich fibrin membrane. BMC Oral Health. 2023 Nov 17;23(1):874. doi: 10.1186/s12903-023-03554-2.
PubMed 37978487
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Augmentation Following Tooth Extraction Using Bovine Xenograft With Platelet Rich Fibrin Membrane
- ClinicalTrials.gov ID
- NCT05791123
- Acronym / sponsor ID
- REC-FDBSU/05012023-03/ER
- Conditions
- Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 30 Mar 2023 (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.
fourteen patients requiring extraction of one posterior tooth with lost buccal bone (>50%) confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. (CBCT) scans, performed before tooth extraction and after 6 months, were used to assess vertical and horizontal bone changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket | Experimental | Procedure: a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients required implant treatment after tooth extraction
- Age group ranged from 20-60 years old.
- Patients could undergo the treatment under local anesthesia.
- Loss of buccal bone (>50%) confirmed by preoperative cone beam computed tomography (CBCT).
- Presence of other socket walls; mesial, distal and lingual walls.
Key exclusion criteria (3 listed)
- Uncontrolled diabetic diseases.
- Uncontrolled hypertension, or hepatic and renal disorders.
- Any systemic diseases associated with bone metabolism.
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 |
|---|---|---|
| a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socketExtraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets. | Procedure or surgery | a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket |
Primary outcome
the change in alveolar bone width and height in mm using CBCT scans.
Time frame: 6 months
Cone Beam Computed Tomography were taken for each patients before tooth extraction and after 6 months, which were used to assess alveolar ridge changes in width and length in mm.
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 30 Mar 2023.
- Derived from this study: PubMed 37978487Elbanna RM, Abdelaziz MS, Alameldeen HE. Augmentation of single tooth extraction socket with deficient buccal walls using bovine xenograft with platelet-rich fibrin membrane. BMC Oral Health. 2023 Nov 17;23(1):874. doi: 10.1186/s12903-023-03554-2.
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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 study testing a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket in people with Bone Regeneration, run by Future University in Egypt at 1 site in Egypt.
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 6 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 30 Mar 2023. 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 Egypt. 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?
the change in alveolar bone width and height in mm using CBCT scans. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791123, which also lists 1 linked publication.
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 30 Mar 2023.