Alveolar Ridge PreservationNCT03487718
A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study.
A study testing Leukocyte platelet rich fibrin plug + d-PTFE membrane and d-PTFE membrane in people with Alveolar Ridge Preservation and Tooth Extraction, run by Firas Al Yafi at 1 site in United States.
Trial summary
This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation, Tooth Extraction
- What is being tested?
- Leukocyte platelet rich fibrin plug + d-PTFE membrane and d-PTFE membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject must have an unsalvageable tooth that is planned for extraction and delayed implant placement.
- The tooth should be free of acute odontogenic infections.
- Extraction sockets with minimal to moderate bony defect.
Who cannot join
- Any patient who is planned for full mouth extraction.
- Heavy smoker (more than 10 cigarettes a day).
- History of malignancy, chemotherapy, radiation therapy.
- Immunosuppressive disease.
- Uncontrolled systemic disease.
- Any contraindications to surgical procedures.
- Females who are pregnant or breastfeeding.
- For multi-rooted teeth, if the most coronal part of the interradicular septum is less than 5 mm below the crest of the bone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Kentucky College of Dentistry
Lexington, Kentucky, 40536
About this study
Official title: Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.
This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures.
Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
Read the detailed description
This 14 weeks longitudinal study was conducted from March 2018 to June 2020, with a 27 participants. No subjects has received placebo medication at any point in the research procedures.
The proposed sample population has been recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have had an unsalvageable tooth that was planned for extraction and delayed implant placement and was assigned into a control group and a test group by chance. Fifteen extraction socket sites of the test group were filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) was laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) was laid on the top of twelve extraction sockets to allow natural blood clot formation in the extraction socket.
The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of implant placement by comparing the percentage of new vital bone in the histomorphometric analysis. The second aim was to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12 weeks of healing.
Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
- Conditions
- Alveolar Ridge Preservation, Tooth Extraction
- Being tested
- Leukocyte platelet rich fibrin plug + d-PTFE membrane, d-PTFE membrane
- Keywords
- Platelet-Rich Fibrin, high-density polytetrafluoroethylene membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte platelet rich fibrin plug + d-PTFE membraneBiological
Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane
d-PTFE membraneDevice
Also called Cytoplast
Following tooth extraction, the socket will be covered with a d-PTFE membrane
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge. Receives: Device: d-PTFE membrane |
| Test group | Experimental | Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge. Receives: Biological: Leukocyte platelet rich fibrin plug + d-PTFE membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the Newly Formed Bone
Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
Measured: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
Secondary outcomes (1)
Dimensional Changes of the Alveolar Ridge (Ridge Width)
Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
Measured: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start26 Mar 2018
- Primary completion30 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alveolar Ridge PreservationStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firas Al Yafi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Firas Al Yafi, University of Kentucky
- Investigators
- Mhdfiras Al Yafi, DDS, Principal investigator, University of Kentucky College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487718
- Sponsor's protocol ID
- 17-0815-F2L
- Status last verified
- May 2021
- First submitted
- 14 Mar 2018
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.
- ClinicalTrials.gov ID
- NCT03487718
- Acronym / sponsor ID
- 17-0815-F2L
- Conditions
- Alveolar Ridge Preservation, Tooth Extraction
- Keywords
- Platelet-Rich Fibrin, high-density polytetrafluoroethylene membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Firas Al YafiUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures.
Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
Detailed description
This 14 weeks longitudinal study was conducted from March 2018 to June 2020, with a 27 participants. No subjects has received placebo medication at any point in the research procedures.
The proposed sample population has been recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have had an unsalvageable tooth that was planned for extraction and delayed implant placement and was assigned into a control group and a test group by chance. Fifteen extraction socket sites of the test group were filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) was laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) was laid on the top of twelve extraction sockets to allow natural blood clot formation in the extraction socket.
The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of implant placement by comparing the percentage of new vital bone in the histomorphometric analysis. The second aim was to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12 weeks of healing.
Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: d-PTFE membraneUnder the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge. |
| Test group | Experimental | Biological: Leukocyte platelet rich fibrin plug + d-PTFE membraneUnder the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject must have an unsalvageable tooth that is planned for extraction and delayed implant placement.
- The tooth should be free of acute odontogenic infections.
- Extraction sockets with minimal to moderate bony defect.
Key exclusion criteria (8 listed)
- Any patient who is planned for full mouth extraction.
- Heavy smoker (more than 10 cigarettes a day).
- History of malignancy, chemotherapy, radiation therapy.
- Immunosuppressive disease.
- Uncontrolled systemic 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 |
|---|---|---|
| Leukocyte platelet rich fibrin plug + d-PTFE membraneFollowing tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane | Biological | Test group |
| d-PTFE membraneAlso: CytoplastFollowing tooth extraction, the socket will be covered with a d-PTFE membrane | Device | Control group |
Primary outcome
Quality of the Newly Formed Bone
Time frame: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
1 secondary outcome
Dimensional Changes of the Alveolar Ridge (Ridge Width)
Time frame: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mhdfiras Al Yafi, DDS principal investigator
University of Kentucky College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukocyte platelet rich fibrin plug + d-PTFE membrane and d-PTFE membrane in people with Alveolar Ridge Preservation and Tooth Extraction, run by Firas Al Yafi at 1 site in United States.
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 3 inclusion and 8 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 24 May 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of the Newly Formed Bone (time frame: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).). 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 24 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.