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

NCT03851289 | Completed

• 1 other identifier: DF RD 1621/0076 (L)
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tooth Extraction

Keywords

socket augmentation; platelet-rich fibrin; calcium sulfate; xenograft

Outcome Measures

Primary Outcomes (4)

• vertical dimension at baseline

  measurements were done on radiograph (CBCT) images

  before extraction

• horizontal dimension at baseline

  measurements were done on radiograph (CBCT) images

  before extraction

• soft tissue level at baseline

  measurements were done on stone models

  before extraction

• volume at baseline

  measurements were done on radiograph (CBCT) images

  before extraction

Secondary Outcomes (4)

• vertical dimension after extraction

  five months after extraction

• horizontal dimension after extraction

  five months after extraction

• soft tissue level after extraction

  five months after extraction

• volume after extraction

  five months after extraction

Study Arms (2)

test (PRF-CS)

EXPERIMENTAL

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

control (PRF-X)

ACTIVE COMPARATOR

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

Interventions

platelet-rich fibrin and calcium sulfate COMBINATION_PRODUCT

test (PRF-CS)

platelet-rich fibrin and xenograft COMBINATION_PRODUCT

control (PRF-X)

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (47)

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• Sultan T, Cheah CW, Ibrahim NB, Asif MK, Vaithilingam RD. Three-dimensional assessment of the extraction sockets, augmented with platelet-rich fibrin and calcium sulfate: A clinical pilot study. J Dent. 2020 Oct;101:103455. doi: 10.1016/j.jdent.2020.103455. Epub 2020 Aug 21.

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MeSH Terms

Interventions

Calcium Sulfate; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Transplantation; Surgical Procedures, Operative

Study Officials

• CHIA W CHEAH

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Study Start: April 22, 2016
• Primary Completion: July 14, 2017
• Study Completion: February 6, 2018
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share