Leukocyte-platelet Rich Fibrin for Alveolar Ridge Preservation

NCT05572242 | Unknown

• 1 other identifier: CPI-ODO:16
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tooth extraction; socket graft; L-PRF; xenogenic bone; dental implant

Outcome Measures

Primary Outcomes (1)

• Bone socket horizontal and vertical changes evaluated using cbct ((cone beam computed tomography)

  Cone-beam computed tomographic (CBCT) imaging will be used to assess the primary outcome (horizontal radiographic changes at -1 mm below the alveolar crest) in both groups between baseline 1 (immediately post socket preservation), visit 4 (4 months after socket preservation), and 12 months after implant rehabilitation. Linear measurements will be performed. The most apical point of the extraction socket will be defined, and two reference lines will be subsequently drawn. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. A horizontal reference line will be drawn perpendicular to the vertical line crossing the apical reference point. Based on these reference lines, the horizontal ridge width will then be measured at -1 mm below the alveolar crest (HW-1). The same procedure will be applied for assessing the horizontal ridge width changes will then be measured at -3 mm (HW-3) and 5- mm (HW-5) below the alveolar crest.

  first cbct immediately after socket preservation surgery, second cbct 4 months after surgery, 12 months after the final restoration of the implant.

Secondary Outcomes (11)

• Mucosal height

  4 months after implant insertion, at the final restoration delivery

• Peri-implant Keratinized Mucosa

  10 days, 6, and 12 months after final restoration

• Bleeding on probing

  10 days, 6, and 12 months after final restoration

• Probing depth

  10 days, 6, and 12 months after final restoration

• Profilometric Changes

  at baseline (socket preservation), 4 months (implant insertion), 10 days and 12 months after final restoration delivery

Study Arms (2)

L-PRF preservation (test)

EXPERIMENTAL

Using L-PRF membranes inside the socket, covering with L-PRF membranes, (test group).

Procedure: Premolar extraction and socked preservation with L-PRF

Xenogenic bone plus collagen membrane (control)

ACTIVE COMPARATOR

Bio-Oss® Collagen at the bone level and application of a collagen matrix (Combi-Kit). Both materials will be used for socket preservation (control).

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

Interventions

Premolar extraction and socked preservation with L-PRF PROCEDURE

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.

L-PRF preservation (test)

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

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.

Xenogenic bone plus collagen membrane (control)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontally healthy individuals with at least 18 years of age
• Good oral hygiene (BOP \& Pl ≤ 20%)
• Patients with a single failing premolar in the maxilla and mandible.
• With or without buccal plate after tooth extraction (similar cases in both groups)
• Surrounded by a mesial and distal natural tooth
• Capability to comply with the study procedures
• Informed Consent as documented by signature

You may not qualify if:

• Pregnant or lactating women
• Known or suspected non-compliance, drug or alcohol abuse
• Smokers (\>10 cigarettes/day)
• Systemic or local conditions presenting a contraindication to implant treatment
• Currently taking drugs that influence bone metabolism
• Use of bisphosphonates in the last 4 years
• History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Geistlich Pharma AG: collaborator
• BioHorizons, Inc.: collaborator

Study Sites (1)

Centro de Salud, Universidad de los Andes

Santiago, Santiago Metropolitan, 8050000, Chile

RECRUITING

Study Officials

• Antonio Sanz, DDS

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Sanz, DDS

CONTACT

56226181372; asanz@clinicasanz.cl

Felipe Cáceres, DDS, MSc

CONTACT

56995097177; felipec.merino@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants: During the socket preservation surgery, the type of intervention will be disclosure to the surgeon. The patient will not have access to this information. Also, during the controls and following interventions (implant placement and rehabilitation), the intervention group will be masked (test or control). Investigator: The investigators will be always masked to the intervention group. (Only the surgeon will be able to know the treatment sequence, during the surgery) Outcomes assessor: The outcome reviewers will be blinded to the intervention. The measures of initial cbct, 4 months cbct control, and the following measurements will be always blind with respect to the intervention group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This study is a non-inferiority clinical controlled trial of parallel groups

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: October 7, 2022
• Study Start: November 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)