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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukocyte platelet rich fibrin plug + d-PTFE membrane | Biological | Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the Newly Formed Bone | Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement. | The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth). |
| Measure | Description | Time Frame |
|---|---|---|
| Dimensional Changes of the Alveolar Ridge (Ridge Width) | Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis. | The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mhdfiras Al Yafi, DDS | University of Kentucky College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity of Kentucky College of Dentistry | Lexington | Kentucky | 40536 | United States |
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All patients were recruited from the University of Kentucky College of Dentistry clinics between Mar 2018 and Dec 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | 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. d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 4, 2018 |
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| d-PTFE membrane | Device | Following tooth extraction, the socket will be covered with a d-PTFE membrane |
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| Test Group |
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. 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | 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. d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane |
| BG001 | Test Group | 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. 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of the Newly Formed Bone | Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement. | Posted | Mean | Standard Deviation | Percentage of newly formed bone | The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth). |
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| Secondary | Dimensional Changes of the Alveolar Ridge (Ridge Width) | Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis. | Posted | Mean | Standard Deviation | mm | The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction. |
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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.
Subjects were monitored for any adverse reactions throughout the study. All adverse events were managed and documented by the principal investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | 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. d-PTFE membrane: Following tooth extraction, the socket will be covered with a d-PTFE membrane | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | Test Group | 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. 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 | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ridge Preservation with Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphomet | University of Kentucky | 8593236193 | firasayafi@uky.edu |
| Mar 22, 2018 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2020 | Mar 20, 2021 | SAP_001.pdf |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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