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.

Tooth Extraction Clinical Trial

Official title:

Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487718
• Other study ID #: 17-0815-F2L
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Ridge Preservation
• Tooth Extraction

Intervention

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

Device:
• d-PTFE membrane
Following tooth extraction, the socket will be covered with a d-PTFE membrane

Locations

Country	Name	City	State
United States	Univerisity of Kentucky College of Dentistry	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Firas Al Yafi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Secondary	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.