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

Not Applicable

Completed

• Conditions: Tooth Extraction
• Interventions: Combination Product: platelet-rich fibrin and calcium sulfate; Combination Product: platelet-rich fibrin and xenograft

• Registration Number: NCT03851289
• Lead Sponsor: University of Malaya

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04-22
• Primary Completion: 2017-07-14
• Study Completion: 2018-02-06
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test (PRF-CS)	platelet-rich fibrin and calcium sulfate	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.
control (PRF-X)	platelet-rich fibrin and xenograft	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.

Primary Outcome Measures

Name	Time	Method
vertical dimension at baseline	before extraction	measurements were done on radiograph (CBCT) images
horizontal dimension at baseline	before extraction	measurements were done on radiograph (CBCT) images
soft tissue level at baseline	before extraction	measurements were done on stone models
volume at baseline	before extraction	measurements were done on radiograph (CBCT) images

Secondary Outcome Measures

Name	Time	Method
vertical dimension after extraction	five months after extraction	measurements were done on radiograph (CBCT) images
horizontal dimension after extraction	five months after extraction	measurements were done on radiograph (CBCT) images
soft tissue level after extraction	five months after extraction	measurements were done on stone models
volume after extraction	five months after extraction	measurements were done on radiograph (CBCT) images