Guided Bone Regeneration With L-PRF in the Atrophic Maxilla - The GLAM Technique

NCT03391258 | Completed

• 1 other identifier: II2015-06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

16 patients with severe resorbed maxillae referred to Implantology Institute® will be submitted to full arch surgery, with simultaneous implant placement and regeneration in the aesthetic zone, with the GLAM technique. Informed consents and local ethical committee clearance will be obtained. Pre, post and 12 months' follow-up CBCT scans will be performed and 2 independent, calibrated operators will analyze the CBCT scans and mean bone values calculated. The distance from the nasopalatine canal to the center of each implant will be determined (4 different locations per patient, corresponding to implants 14; 11; 21; 24) and it will be the reference to other CBCTs. Implant length will be measured, from the neck (site 1) to the top and then a middle point will be assessed (site 2). Post-Surgical Volume (mm) will be determined from the most palatal point of cortical bone until the most buccal regenerated bone in each CBCT. Regenerated bone gain (mm) at post-op and at 1-year CBCTs will be calculated by the difference between pre and post-op or pre-op and 1 year CBCT measures, respectively. Regenerated Bone stability (%), defined as the percentage of regenerated bone at 12 months, will be calculated as the comparison between CBCT immediately after surgery and the CBCT at 12 months. Results will be presented as mean, with 95% CI.

Conditions

Bone Regeneration

Keywords

Maxilary atrophy; Leucocyte-platelet-rich-fibrin; bone resorption; autologous growth factors; guided-bone-regeneration; lip support

Outcome Measures

Primary Outcomes (1)

• Changes in Regenerated Bone Gain (mm)

  Measured at the post-op and the 12 months CBCT scans from the most palatal point of cortical bone until the most buccal point of regenerated bone, perpendicular to the implant's long axis. Calculated by the difference between pre and post-op CBCTs (regenerated bone gain at post-op) and by the difference between pre-op and 12 months CBCT measures (regenerated bone gain at 12 months).

  Pre-surgery, Baseline (0 days) and 12 month follow-up

Secondary Outcomes (2)

• Regenerated Bone Stability (%)

  Baseline (0 days) and 12 month follow-up

• Post-Surgical Regenerated Bone Volume (mm)

  Baseline (0 days)

Study Arms (1)

Bone Regeneration with GLAM technique

EXPERIMENTAL

At the beginning of each surgery, a venipuncture will be performed, to obtain the L-PRF membranes. Also, two white topped tubes will be centrifuged for 3 minutes to obtain PRP. After implant placement, achieving a primary stability of at least 45 Ncm, the stiff bone-block (L-PRF membranes and PRP combined with bovine xenograft) will be used in the buccal plate of the pre-maxilla, to enhance bone volume in the esthetic area.

Procedure: Bone Regeneration with GLAM technique

Interventions

Bone Regeneration with GLAM technique PROCEDURE

Bone regeneration with GLAM technique in full arch implant supported rehabilitation

Bone Regeneration with GLAM technique

Eligibility Criteria

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

You may qualify if:

• ≥18years of age, ASA I or ASA II patients

You may not qualify if:

• ASA III or ASA IV patients; uncontrolled diabetes, immunosuppressant medication, heavy smokers or pre-surgical infectious area next to the surgical site

Sponsors & Collaborators

• Implantology Institute: lead

Study Sites (1)

Instituto de Implantologia

Lisbon, 1070-064, Portugal

Location

MeSH Terms

Conditions

Bone Resorption

Interventions

Bone Regeneration

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bone Remodeling; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Regeneration; Biological Phenomena

Study Officials

• Duarte Marques, DDS, PhD

  Implantology Institute

  PRINCIPAL INVESTIGATOR

• João Caramês, DDS, PhD

  Implantology Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To describe the dimensional changes (based on CBCT scans) occurred 12 months after implant placement and simultaneous regeneration with L-PRF and bovine bone graft in the aesthetic zone of atrophic maxillae in full arch implant supported rehabilitations

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 5, 2018
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

PT (1)