An interventional study of Leukocyte platelet rich fibrin plug + d-PTFE membrane and d-PTFE membrane in Alveolar Ridge Preservation and Tooth Extraction, sponsored by Firas Al Yafi. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by Firas Al Yafi · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Device: d-PTFE membrane
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.
Biological: Leukocyte platelet rich fibrin plug + d-PTFE membrane
Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane
Following tooth extraction, the socket will be covered with a d-PTFE membrane
Also known as: Cytoplast
Quality of the Newly Formed Bone
Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
Time frame: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
Dimensional Changes of the Alveolar Ridge (Ridge Width)
Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
Time frame: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
All patients were recruited from the University of Kentucky College of Dentistry clinics between Mar 2018 and Dec 2019.
| Milestone | Control Group | Test Group |
|---|---|---|
| Started | 12 | 15 |
| Completed | 11 | 11 |
| Not completed | 1 | 4 |
Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
| Percentage of newly formed bone | Control Group | Test Group |
|---|---|---|
| Quality of the Newly Formed Bone | 24.14 ± 16.26 | 19.12 ± 10.57 |
Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
| mm | Control Group | Test Group |
|---|---|---|
| Dimensional Changes of the Alveolar Ridge (Ridge Width) | 0.81 ± 0.59 | 1.22 ± 0.97 |
Collected over Adverse event data collection was performed over 14 weeks for each patient, The patient's visits included: • Baseline visit. • Week-one visit. • Week-four visit. • Week-twelve visit. • Week-fourteen visit. All procedures described above were standard of care except for bone core biopsy which was research related.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Test Group | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | Control Group | Test Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 9 | 12 | 21 |
| Sex: Female, Male(Participants) | Control Group | Test Group | Total |
|---|---|---|---|
| Female | 5 | 8 | 13 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Control Group | Test Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 15 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control Group | Test Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 9 | 13 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control Group | Test Group | Total |
|---|---|---|---|
| United States | 12 | 15 | 27 |
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