Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation

Study Overview
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Brief Summary
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This study evaluated the effectiveness of socket grafting material, combination of plate-rich fibrin and calcium sulfate. 5 subjects were grafted with this material, 5 subjects were grafted with combination of plate-rich fibrin and xenograft.

Detailed Description
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Calcium sulfate (CS), an alloplastic material, is widely accepted as a socket grafting material and undergoes rapid and complete resorption. Studies have shown that CS creates an osteoconductive lattice that stimulates bone ingrowth into a defect. PRF poses multiple growth factors, anti-inflammatory cytokines and adhesion molecules. It is biologically active up to one week. The combination of these 2 materials will serve as good grafting material for tooth socket, in order to preserve vertical and horizontal dimensions.

Official Title
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Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation

Conditions
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Tooth Extraction

Intervention / Treatment
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* Combination Product: platelet-rich fibrin and calcium sulfate
* Combination Product: platelet-rich fibrin and xenograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: maxillary premolar teeth requiring extraction neighboring mesial and distal sound/restored teeth present alveolar bone level (measured from periapical radiographs) more than 50% of the root length age ranges from 25-55 years Exclusion Criteria: bony fenestration of the socket wall confirmed from CBCT scan acute signs of infection periodontally compromised teeth absence of buccal plates any systemic disease which may hinder the healing process

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test (PRF-CS)<br>After atraumatic tooth extraction, the socket was gently curettage and irrigated with saline. Combination of platelet-rich fibrin and calcium sulfate was placed into the socket followed by a PRF plug . Black silk suture (3-0) was placed on mesial, mid and distal using simple interrupted technique. | Combination Product: platelet-rich fibrin and calcium sulfate<br> <br> |
| Active Comparator: control (PRF-X)<br>After atraumatic tooth extraction, the socket was gently curettage and irrigated with saline. Combination of platelet-rich fibrin and xenograft (MinerOss® X) was placed into the socket followed by a PRF plug . Black silk suture (3-0) was placed on mesial, mid and distal using simple interrupted technique. | Combination Product: platelet-rich fibrin and xenograft<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertical dimension at baseline | measurements were done on radiograph (CBCT) images | before extraction | 
| horizontal dimension at baseline | measurements were done on radiograph (CBCT) images | before extraction | 
| soft tissue level at baseline | measurements were done on stone models | before extraction | 
| volume at baseline | measurements were done on radiograph (CBCT) images | before extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertical dimension after extraction | measurements were done on radiograph (CBCT) images | five months after extraction | 
| horizontal dimension after extraction | measurements were done on radiograph (CBCT) images | five months after extraction | 
| soft tissue level after extraction | measurements were done on stone models | five months after extraction | 
| volume after extraction | measurements were done on radiograph (CBCT) images | five months after extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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socket augmentation, platelet-rich fibrin, calcium sulfate, xenograft