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.
Condition: Alveolar Ridge Preservation; Tooth Extraction
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Leukocyte platelet rich fibrin plug + d-PTFE membrane; d-PTFE membrane
Intervention type(s): Biological; Device
Intervention description(s): Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane; Following tooth extraction, the socket will be covered with a d-PTFE membrane
Other intervention name(s): Cytoplast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-Rich Fibrin; high-density polytetrafluoroethylene membrane