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

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851289
• Other study ID #: DF RD 1621/0076 (L)
• Status: Completed
• Phase: N/A
• Start date: April 22, 2016
• Est. completion date: February 6, 2018

Study information

• Verified date: March 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 6, 2018
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

Combination Product:
• platelet-rich fibrin and calcium sulfate

• platelet-rich fibrin and xenograft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vertical dimension at baseline	measurements were done on radiograph (CBCT) images	before extraction
Primary	horizontal dimension at baseline	measurements were done on radiograph (CBCT) images	before extraction
Primary	soft tissue level at baseline	measurements were done on stone models	before extraction
Primary	volume at baseline	measurements were done on radiograph (CBCT) images	before extraction
Secondary	vertical dimension after extraction	measurements were done on radiograph (CBCT) images	five months after extraction
Secondary	horizontal dimension after extraction	measurements were done on radiograph (CBCT) images	five months after extraction
Secondary	soft tissue level after extraction	measurements were done on stone models	five months after extraction
Secondary	volume after extraction	measurements were done on radiograph (CBCT) images	five months after extraction