Clinical trial NCT03487718: 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.
Official title: Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Preservation
Tooth Extraction
Keywords: Platelet-Rich Fibrin
high-density polytetrafluoroethylene membrane
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of the Newly Formed Bone
timeFrame: The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
Secondary outcomes:
measure: Dimensional Changes of the Alveolar Ridge (Ridge Width)
timeFrame: The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Univerisity of Kentucky College of Dentistry
state: Kentucky
Study officials:
affiliation: University of Kentucky College of Dentistry
name: Mhdfiras Al Yafi, DDS
role: PRINCIPAL_INVESTIGATOR
References: