Platelet Rich Fibrin (PRF) in Socket Preservation Technique

Study Overview
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Brief Summary
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The loss of a tooth or change in its function is lead to a change in alveolar ridge's height and volume. Socket preservation (SP) is a procedure designed to prevent or limit alteration of the post-extraction bone ridge to achieve an optimal prosthetic implant rehabilitation. The aim of this randomized-controlled clinical trial is to suggest that platelet rich fibrin (PRF) as solely grafting material may be a valid tool in this technique.

Detailed Description
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80 patients with mandibular or maxillary premolars that need to be extracted will be recruited. All patients will be randomly treated by using two different therapeutic approaches, thereby yielding two different study groups, each of which is composed of 40 cases: in the test group the socket preservation technique with PRF will be performed, in control group the post-extraction socket is left healing spontaneously without performing socket preservation. A software will be used to produce a random sequence of 80 integer numbers without duplicates generated by a software and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to test or control group. All patients are informed by the written consent obtained that they could be causally allocated to one of the two groups. Before extraction, patients should undergo to periodontal treatment and instrumental investigations such as orthopantomography. After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the bone cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and the granulation tissue are removed. In the test group, a blood collection of 40 ml will be performed and PRF is made according to the manufacturer instructions. One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements immediately after surgery and three months later. Patients will be checked at 3 days, 1 week after surgery (removal of sutures), 14 days after surgery, 28 days after surgery and at 3 months after surgery (at the time of implant placement). A Cone Beam Computed Tomography (CBCT) is prescribed immediately after surgery and 3 months after surgery before implant placement. Differences between the two analysed groups will be evaluate by test t-student through a statistic software.

Official Title
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The Use of Platelet-Rich Fibrin as Solely Filling Material in Socket Preservation Technique: a Randomized-controlled Clinical Trial

Conditions
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Alveolar Bone Loss, Tooth Extraction

Intervention / Treatment
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* Procedure: Dental extraction
* Device: Platelet Rich Fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mandibular or maxillary premolars that need to be extracted due to endodontic failure, caries or fractures and will need to be replaced with a dental implant after 3 months of healing Full mouth plaque score ≤ 25% at onset Full mouth bleeding score ≤ 25% at onset Integrity of the alveolar walls after extraction Vestibular wall thickness < 1 mm Patients able to understand and sign informed consensus Exclusion Criteria: Significant medical conditions contraindicating surgery Pregnancy and breastfeeding Tobacco smoking (>15 cigarettes per day) Immunocompromised patients Alcohol and drug abuse Uncooperative patients Periodontally compromised patients Acute abscesses at the extraction site Other dental elements that are not premolars Patients who do not show up for scheduled checkups

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Socket ridge preservation with PRF<br>40 ml of blood is drawn and collected in plastic tubes of 10 ml. The tubes are placed in a centrifuge at 2700 rpm for 12 minutes to get the clot of fibrin. After extraction, the clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted. | Procedure: Dental extraction<br>* After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and granulation tissue inside the socket are removed.<br>Device: Platelet Rich Fibrin<br>* The clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.<br>|
| Active Comparator: Spontaneous healing<br>No treatment is applied. The socket is made to heal spontaneously. | Procedure: Dental extraction<br>* After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and granulation tissue inside the socket are removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal probe - alveolar crest distance | Vertical distance measured with a periodontal probe from the alveolar crest (AC) to a reference periodontal probe (P) connecting the cement-enamel junction (CEJ) of the teeth adjacent. | Immediately after surgery, 3 months after surgery | 
| Width | Horizontal alveolar ridge thickness from the external face of the buccal wall to the outer face of the lingual side is measured with a hand caliper, 1 mm apically from the alveolar ridge in the central area. | Immediately after surgery, 3 months after surgery | 
| Vestibular bone wall thickness | It is measured with a hand caliper at the center of the vestibular wall, 1 mm apically from the ridge. | Immediately after surgery, 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing index | Landry index including description from a Very poor to an Excellent wound healing | 3, 7, 14, 28 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implant, Socket ridge preservation, Platelet Rich Fibrin