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OpenTrials
Completed

NCT Number: NCT03851289

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

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.

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platelet-rich fibrin and calcium sulfate

Combination Product

platelet-rich fibrin and xenograft

Combination Product

Primary outcomes

  1. vertical dimension at baseline

    Time frame: before extraction

    measurements were done on radiograph (CBCT) images

  2. horizontal dimension at baseline

    Time frame: before extraction

    measurements were done on radiograph (CBCT) images

  3. soft tissue level at baseline

    Time frame: before extraction

    measurements were done on stone models

  4. volume at baseline

    Time frame: before extraction

    measurements were done on radiograph (CBCT) images

Secondary outcomes

  1. vertical dimension after extraction

    Time frame: five months after extraction

    measurements were done on radiograph (CBCT) images

  2. horizontal dimension after extraction

    Time frame: five months after extraction

    measurements were done on radiograph (CBCT) images

  3. soft tissue level after extraction

    Time frame: five months after extraction

    measurements were done on stone models

  4. volume after extraction

    Time frame: five months after extraction

    measurements were done on radiograph (CBCT) images

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 22, 2019
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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