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

Primary Purpose

Atrophic Maxilla, Ridge Preservation

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

L-PRF

A-PRF

About this trial

This is an interventional treatment trial for Atrophic Maxilla focused on measuring leucocyte- and platelet rich fibrin, ridge preservation, growth factors, platelet concentrates

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

L-PRF

A-PRF

Control

Arm Description

One socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place.

One socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place.

The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.

Outcomes

Primary Outcome Measures

Changes horizontal width at crest -1mm

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03268512

First Posted

August 28, 2017

Last Updated

October 10, 2018

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT03268512

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 22, 2015 (Actual)

Primary Completion Date

October 10, 2018 (Actual)

Study Completion Date

October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrophic Maxilla, Ridge Preservation

Keywords

leucocyte- and platelet rich fibrin, ridge preservation, growth factors, platelet concentrates

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

L-PRF

Arm Type

Experimental

Arm Description

One socket will be filled with L-PRF membranes and covered with at least 2 L-PRF membranes. A modified horizontal mattress will be place as suture to keep the L-PRF in place.

Arm Title

A-PRF

Arm Type

Experimental

Arm Description

One socket will be filled with A-PRF membranes and covered with at least 2 A-PRF membranes. A modified horizontal mattress will be place as suture to keep the A-PRF in place.

Arm Title

Control

Arm Type

No Intervention

Arm Description

The socket will be filled with a natural blood clot. A modified horizontal mattress will be place as suture.

Intervention Type

Other

Intervention Name(s)

L-PRF

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

A-PRF

Intervention Description

Primary Outcome Measure Information:

Title

Changes horizontal width at crest -1mm

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Post-operative scores

Description

Post-operative discomfort measured with VAS

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana B Castro, PhD student

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Leuven

City

Leuven

State/Province

Vlaams-Brabant

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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