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Completed

NCT Number: NCT03268512

Effect of L-PRF and A-PRF in Ridge Preservation

A split-mouth design study will be performed regarding the use of platelet concentrates on ridge preservation: L-PRF vs A-PRF vs control. Patient needing multiple teeth extractions in the upper jaw (single-rooted teeth) will be recruited. The use of each platelet concentrate or control will be randomized by means of a computer program. The results will be analysed clinical and radiographically (CBCT). When the subject will choose for implant rehabilitation, a biopsy will be taken in the site of the preserved sockets. The region will be localized with a customized stent, fabricated with the position of the extracted teeth. VAS scales will be provided to evaluate the post-operative discomfort.

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Key information

Conditions

Atrophic Maxilla Bone Diseases Bone Resorption Jaw Diseases Maxillary Diseases Musculoskeletal Diseases Ridge Preservation Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 3 single-rooted teeth needed to be extracted in the upper jaw
  • patient in good general health as documented by self-assessment
  • patients must be committed to the study and must be willing to sing the informed consent.

Exclusion criteria

  • any systemic medical condition that could interfere with the surgical procedure or planned treatment.
  • current pregnancy or breast feeding
  • radiotherapy or chemotherapy in head and neck area
  • intravenous and oral bisphosphonate
  • patients smoking >20 cig/day
  • unwillingness to return for the follow-up examination

Treatment and study plan

L-PRF

Other

Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.

A-PRF

Other

Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called "buffy coat" where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days.

Primary outcomes

  1. Changes horizontal width at crest -1mm

    Time frame: 3 months

    Primary outcome variables were defined as the changes in horizontal width at crest-1 mm levels.

Secondary outcomes

  1. Changes horizontal width at crest -3 mm and 5 mm; vertical resorption; socket fill

    Time frame: 3 months

    Changes in horizontal width at crest -3 mm and 5 mm; vertical resorption at the lingual and buccal side; socket fill.

Other outcomes

  1. Post-operative scores

    Time frame: 1 week

    Post-operative discomfort measured with VAS

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Use of L-PRF and A-PRF in Ridge Preservation: a Randomized Controlled Clinical Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2017
Registry last updated
Oct 11, 2018

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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