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AzTrials

Tooth ExtractionNCT03851289

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

A study testing platelet-rich fibrin and calcium sulfate and platelet-rich fibrin and xenograft in people with Tooth Extraction, run by University of Malaya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Tooth Extraction
What is being tested?
platelet-rich fibrin and calcium sulfate and platelet-rich fibrin and xenograft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
22 Apr 2016to 6 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the 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.

Being tested
platelet-rich fibrin and calcium sulfate, platelet-rich fibrin and xenograft
Keywords
socket augmentation, platelet-rich fibrin, calcium sulfate, xenograft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • platelet-rich fibrin and calcium sulfateCombination product

  • platelet-rich fibrin and xenograftCombination product

Study groups in NCT03851289
Study groupRoleWhat they receive
test (PRF-CS)ExperimentalAfter 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.
Receives: Combination Product: platelet-rich fibrin and calcium sulfate
control (PRF-X)Active comparatorAfter 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.
Receives: Combination Product: platelet-rich fibrin and xenograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. vertical dimension at baseline

    measurements were done on radiograph (CBCT) images

    Measured: before extraction

  2. horizontal dimension at baseline

    measurements were done on radiograph (CBCT) images

    Measured: before extraction

  3. soft tissue level at baseline

    measurements were done on stone models

    Measured: before extraction

  4. volume at baseline

    measurements were done on radiograph (CBCT) images

    Measured: before extraction

Secondary outcomes (4)

  1. vertical dimension after extraction

    measurements were done on radiograph (CBCT) images

    Measured: five months after extraction

  2. horizontal dimension after extraction

    measurements were done on radiograph (CBCT) images

    Measured: five months after extraction

  3. soft tissue level after extraction

    measurements were done on stone models

    Measured: five months after extraction

  4. volume after extraction

    measurements were done on radiograph (CBCT) images

    Measured: five months after extraction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start22 Apr 2016
  3. Primary completion14 Jul 2017
  4. Study completion6 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851289
Sponsor's protocol ID
DF RD 1621/0076 (L)
Status last verified
Mar 2020
First submitted
20 Feb 2019
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: socio demographic background

Publications

  • Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.

    PubMed 15691354

  • Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.

    PubMed 19885449

  • Cardaropoli D, Cardaropoli G. Preservation of the postextraction alveolar ridge: a clinical and histologic study. Int J Periodontics Restorative Dent. 2008 Oct;28(5):469-77.

    PubMed 18990998

  • Fickl S, Zuhr O, Wachtel H, Stappert CF, Stein JM, Hurzeler MB. Dimensional changes of the alveolar ridge contour after different socket preservation techniques. J Clin Periodontol. 2008 Oct;35(10):906-13. doi: 10.1111/j.1600-051X.2008.01305.x. Epub 2008 Aug 17.

    PubMed 18713258

  • Jambhekar S, Kernen F, Bidra AS. Clinical and histologic outcomes of socket grafting after flapless tooth extraction: a systematic review of randomized controlled clinical trials. J Prosthet Dent. 2015 May;113(5):371-82. doi: 10.1016/j.prosdent.2014.12.009. Epub 2015 Mar 4.

    PubMed 25749077

  • Anwandter A, Bohmann S, Nally M, Castro AB, Quirynen M, Pinto N. Dimensional changes of the post extraction alveolar ridge, preserved with Leukocyte- and Platelet Rich Fibrin: A clinical pilot study. J Dent. 2016 Sep;52:23-9. doi: 10.1016/j.jdent.2016.06.005. Epub 2016 Jun 20.

    PubMed 27338946

  • Guarnieri R, Pecora G, Fini M, Aldini NN, Giardino R, Orsini G, Piattelli A. Medical grade calcium sulfate hemihydrate in healing of human extraction sockets: clinical and histological observations at 3 months. J Periodontol. 2004 Jun;75(6):902-8. doi: 10.1902/jop.2004.75.6.902.

    PubMed 15295959

  • Strocchi R, Orsini G, Iezzi G, Scarano A, Rubini C, Pecora G, Piattelli A. Bone regeneration with calcium sulfate: evidence for increased angiogenesis in rabbits. J Oral Implantol. 2002;28(6):273-8. doi: 10.1563/1548-1336(2002)0282.3.CO;2.

    PubMed 12498535

  • Simon BI, Gupta P, Tajbakhsh S. Quantitative evaluation of extraction socket healing following the use of autologous platelet-rich fibrin matrix in humans. Int J Periodontics Restorative Dent. 2011 Jun;31(3):285-95.

    PubMed 21556385

  • Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.

    PubMed 19089687

  • Cheah CW, Vaithilingam RD, Siar CH, Swaminathan D, Hornbuckle GC. Histologic, histomorphometric, and cone-beam computerized tomography analyses of calcium sulfate and platelet-rich plasma in socket preservation: a pilot study. Implant Dent. 2014 Oct;23(5):593-601. doi: 10.1097/ID.0000000000000148.

    PubMed 25192162

  • Yilmaz S, Karaca EO, Ipci SD, Cakar G, Kuru BE, Kullu S, Horwitz J. Radiographic and histologic evaluation of platelet-rich plasma and bovine-derived xenograft combination in bilateral sinus augmentation procedure. Platelets. 2013;24(4):308-15. doi: 10.3109/09537104.2012.695033. Epub 2012 Jun 21.

    PubMed 22720715

  • Potres Z, Deshpande S, Kloeppel H, Voss K, Klineberg I. Assisted Wound Healing and Vertical Bone Regeneration with Simultaneous Implant Placement: A Histologic Pilot Study. Int J Oral Maxillofac Implants. 2016 Jan-Feb;31(1):45-54. doi: 10.11607/jomi.3951.

    PubMed 26800162

  • Manavella V, Romano F, Corano L, Bignardi C, Aimetti M. Three-Dimensional Volumetric Changes in Severely Resorbed Alveolar Sockets After Ridge Augmentation with Bovine-Derived Xenograft and Resorbable Barrier: A Preliminary Study on CBCT Imaging. Int J Oral Maxillofac Implants. 2018 March/April;33(2):373-382. doi: 10.11607/jomi.5684. Epub 2017 Aug 17.

    PubMed 28817739

  • Aimetti M, Manavella V, Corano L, Ercoli E, Bignardi C, Romano F. Three-dimensional analysis of bone remodeling following ridge augmentation of compromised extraction sockets in periodontitis patients: A randomized controlled study. Clin Oral Implants Res. 2018 Feb;29(2):202-214. doi: 10.1111/clr.13099. Epub 2017 Nov 17.

    PubMed 29148597

Questions about this trial

What is this clinical trial studying?

A study testing platelet-rich fibrin and calcium sulfate and platelet-rich fibrin and xenograft in people with Tooth Extraction, run by University of Malaya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

vertical dimension at baseline (time frame: before extraction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851289, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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