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

March 23, 2020 updated by: Dr CHEAH CHIA WEI, University of Malaya
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: CHIA W CHEAH, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2016

Primary Completion (Actual)

July 14, 2017

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF RD 1621/0076 (L)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

socio demographic background

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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