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.
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| ClinicalTrials.gov Identifier: NCT03487718 |
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Recruitment Status :
Completed
First Posted : April 4, 2018
Results First Posted : May 24, 2021
Last Update Posted : May 24, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alveolar Ridge Preservation Tooth Extraction | Biological: Leukocyte platelet rich fibrin plug + d-PTFE membrane Device: d-PTFE membrane | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study. |
| Actual Study Start Date : | March 26, 2018 |
| Actual Primary Completion Date : | March 30, 2020 |
| Actual Study Completion Date : | June 30, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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.
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Device: d-PTFE membrane
Following tooth extraction, the socket will be covered with a d-PTFE membrane
Other Name: Cytoplast |
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Experimental: 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.
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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 |
- 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.
- Dimensional Changes of the Alveolar Ridge (Ridge Width) [ Time Frame: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction. ]Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487718
| United States, Kentucky | |
| Univerisity of Kentucky College of Dentistry | |
| Lexington, Kentucky, United States, 40536 | |
| Principal Investigator: | Mhdfiras Al Yafi, DDS | University of Kentucky College of Dentistry |
Documents provided by Firas Al Yafi, University of Kentucky:
| Responsible Party: | Firas Al Yafi, Periodontology Resident, University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT03487718 |
| Other Study ID Numbers: |
17-0815-F2L |
| First Posted: | April 4, 2018 Key Record Dates |
| Results First Posted: | May 24, 2021 |
| Last Update Posted: | May 24, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Platelet-Rich Fibrin high-density polytetrafluoroethylene membrane |