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

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ClinicalTrials.gov Identifier: NCT03851289
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr CHEAH CHIA WEI, University of Malaya

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 22, 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851289


Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: CHIA W CHEAH University of Malaya
  Study Documents (Full-Text)

Documents provided by Dr CHEAH CHIA WEI, University of Malaya:

Publications:
Kalash S, Aboelsaad N, Shokry M, Choukroun J. The efficiency of using advanced PRF-xenograft mixture around immediate implants in the esthetic zone: a randomized controlled clinical trial. Journal of Osseointegration. 9(4):317-22, 2017
Abraham S, Deepak K, Ambili R, Preeja C, Archana V. Gingival biotype and its clinical significance-A review. The Saudi Journal for Dental Research. 5(1):3-7, 2014

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Responsible Party: Dr CHEAH CHIA WEI, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT03851289     History of Changes
Other Study ID Numbers: DF RD 1621/0076 (L)
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: socio demographic background

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr CHEAH CHIA WEI, University of Malaya:
socket augmentation
platelet-rich fibrin
calcium sulfate
xenograft

Additional relevant MeSH terms:
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Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents