Leukocyte-platelet Rich Fibrin for Alveolar Ridge Preservation

Summary

After tooth extraction, there is a subsequent bone loss as a part of the natural healing of the tissue. Up to 50% of bone loss occurs during the first three months after extraction, jeopardizing a possible implant treatment. Alveolar ridge preservation techniques reduce bone loss, allowing a future implant treatment. Different bone filling materials have been used with good clinical results. The second-generation platelet concentrates (L-PRF) have recently been shown to induce bone regeneration when filling the socket after extraction, with significant biological and economic advantages. The hypothesis of this study is to test whether or not the use of L-PRF in alveolar ridge preservation results in a non-inferior horizontal radiographic change compared with the combination of a xenogeneic bone substitute with a collagen matrix.

Conditions

• Alveolar Ridge Enlargement

Interventions

PROCEDURE

Premolar extraction and socked preservation with L-PRF

Partially edentulous patients in need of a single-tooth extraction in the premolar region\[ (maxilla or mandible), with two neighboring natural teeth, will be included in the study. The tooth will be luxated first with elevators and then carefully extracted with forceps without raising a flap. L-PRF group will use 2-5 PRF clots, depending on the size of the socket, which will be inserted and compressed with a large plunger until they reach the alveolar crest. The site will thereafter be covered with L-PRF membranes. Then, crossed horizontal mattress suture will be placed followed by single interrupted sutures for stabilization. No efforts will be undertaken to obtain primary wound closure. The grafted socket will be left to heal for 4 months. After 4 months of socket preservation, a dental implant will be inserted into the socket. After 4 months of implant healing, a cad cam final restoration will be delivered. The follow-up will be up to 12 months after the final restoration.

PROCEDURE

Premolar extraction and socked preservation with Xenogenic bone and collagen membrane.

Partially edentulous patients in need of a single-tooth extraction in the premolar region (maxilla or mandible), with two neighboring natural teeth, will be included in the study. The tooth will be luxated first with straight and angled elevators and then carefully extracted with forceps without raising a flap. In the control group, the socket will be grafted with xenogeneic bone substitute material (up to the palatal/lingual bone crest) and covered with a collagen matrix. Single interrupted sutures will be placed to stabilize the collagen matrix. Sutures will be removed at 7-10 days. The grafted socket will then be left to heal for a period of 4 months. The xenogenic material will be Bio-Oss Collagen® and collagen matrix Bio-Gide® . After 4 months of socket preservation, a dental implant will be placed. After 4 months of implant healing, a cad cam final restoration will be delivered. The follow-up will be up to 12 months after the final restoration.

Sponsors & Collaborators

• Geistlich Pharma AG

  collaborator INDUSTRY

• BioHorizons, Inc.

  collaborator INDUSTRY

• Universidad de los Andes, Chile

  lead OTHER

Principal Investigators

• Antonio Sanz, DDS · Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-01

Primary Completion

2024-10-31

Completion

2025-03-31

Countries

• Chile

Study Locations