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Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

NCT04343066 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-10-23

No results posted yet for this study

Summary

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

Conditions

  • Dental Implantation
  • Bone Remodeling

Interventions

DEVICE

Implant insertion

In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking \< 10 cigarettes, previous horizontal bone augmentation, FMBS \<20% and FMPS \< 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Nada Naaman, PhD · Saint-Joseph University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2019-11-30
Completion
2020-12-30
FDA Device
Yes

Countries

  • Lebanon

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 NCT04343066 on ClinicalTrials.gov