Clinical Trial

Improving Bone Formation Following Tooth Removal

Study Description

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.

This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects will receive placebo medication at any point in the research procedures. The proposed sample population will be recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have an unsalvageable tooth that is planned for extraction and delayed implant placement and will be assigned into a control group and a test group by chance. Twenty extraction socket sites of the test group will be filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) will be laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) will be laid on the top of twenty 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 is to assess the primary stability of the implant using the resonance frequency analysis (RFA) and insertional torque (IT) of the implant. The third aim is 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. The fourth aim is to assess the soft tissue healing with a series of intraoral occlusal photographs. 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Biological - d-PTFE membrane

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

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03487718

ParticipAid ID

Qe1gqb