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.

NCT03487718 | Completed Results DMC FDA Device

• 1 other identifier: 17-0815-F2L
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Ridge Preservation; Tooth Extraction

Keywords

Platelet-Rich Fibrin; high-density polytetrafluoroethylene membrane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dimensional Changes of the Alveolar Ridge (Ridge Width)

  The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.

Study Arms (2)

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.

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.

Biological: Leukocyte platelet rich fibrin plug + d-PTFE membrane

Interventions

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

Test group

d-PTFE membrane DEVICE

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

Also known as: Cytoplast

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Firas Al Yafi: lead

Study Sites (1)

Univerisity of Kentucky College of Dentistry

Lexington, Kentucky, 40536, United States

Location

Results Point of Contact

• Title: Ridge Preservation with Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphomet
• Organization: University of Kentucky

firasayafi@uky.edu

8593236193

Study Officials

• Mhdfiras Al Yafi, DDS

  University of Kentucky College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Periodontology Resident

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 4, 2018
• Study Start: March 26, 2018
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 24, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)