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

Ridge Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268512
• Other study ID #: B322201525149
• Status: Completed
• Phase: N/A
• Start date: August 22, 2015
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Maxilla
• Ridge Preservation

Intervention

Other:
• L-PRF
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
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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative scores	Post-operative discomfort measured with VAS	1 week
Primary	Changes horizontal width at crest -1mm	Primary outcome variables were de?ned as the changes in horizontal width at crest-1 mm levels.	3 months
Secondary	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 ?ll.	3 months