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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: d-PTFE membrane
    Following tooth extraction, the socket will be covered with a d-PTFE membrane
    Other names:
    • Cytoplast
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.
  • 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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Univerisity of Kentucky College of Dentistry
Lexington, Kentucky 40536
Contact:
Firas Al Yafi, DDM
859-323-3368
firasyafi@uky.edu

More Details

NCT ID
NCT03487718
Status
Recruiting
Sponsor
Firas Al Yafi

Study Contact

Mhdfiras Al Yafi, DDS
859-323-6193
firasyafi@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.