Clinical trial NCT03851289: Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation
Official title: Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Keywords: socket augmentation
platelet-rich fibrin
calcium sulfate
xenograft
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: vertical dimension at baseline
timeFrame: before extraction
measure: horizontal dimension at baseline
timeFrame: before extraction
measure: soft tissue level at baseline
timeFrame: before extraction
measure: volume at baseline
timeFrame: before extraction
Secondary outcomes:
measure: vertical dimension after extraction
timeFrame: five months after extraction
measure: horizontal dimension after extraction
timeFrame: five months after extraction
measure: soft tissue level after extraction
timeFrame: five months after extraction
measure: volume after extraction
timeFrame: five months after extraction
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: CHIA W CHEAH
role: PRINCIPAL_INVESTIGATOR
References:
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