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

NCT03391258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-13

No results posted yet for this study

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

Interventions

PROCEDURE

Bone Regeneration with GLAM technique

Bone regeneration with GLAM technique in full arch implant supported rehabilitation

Sponsors & Collaborators

  • Implantology Institute

    lead OTHER

Principal Investigators

  • Duarte Marques, DDS, PhD · Implantology Institute

  • João Caramês, DDS, PhD · Implantology Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03391258 on ClinicalTrials.gov