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

Sponsor

University of Malaya (Other)

Overall Status

Completed

CT.gov ID

NCT03851289

Collaborator

(none)

Enrollment

Arms

21.5

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Extraction	Combination Product: platelet-rich fibrin and calcium sulfate Combination Product: platelet-rich fibrin and xenograft	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 22, 2016

Actual Primary Completion Date :

Jul 14, 2017

Actual Study Completion Date :

Feb 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: test (PRF-CS) 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
Active Comparator: control (PRF-X) 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

Arm

Intervention/Treatment

Experimental: test (PRF-CS)

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

Active Comparator: control (PRF-X)

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Malaya

Investigators

Principal Investigator: CHIA W CHEAH, University of Malaya

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Oct 24, 2018

More Information

Publications

Responsible Party:

Dr CHEAH CHIA WEI, Principal Investigator, University of Malaya

ClinicalTrials.gov Identifier:

NCT03851289

Other Study ID Numbers:

DF RD 1621/0076 (L)

First Posted:

Feb 22, 2019

Last Update Posted:

Mar 25, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr CHEAH CHIA WEI, Principal Investigator, University of Malaya

Additional relevant MeSH terms:

Calcium

Study Results

No Results Posted as of Mar 25, 2020