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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02703480
Other study ID # 11877
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date June 2023

Study information

Verified date February 2022
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
d-PTFE
high-density polytetrafluoroethylene (d-PTFE) membrane
Ti-mesh
Titanium mesh

Locations

Country Name City State
United States Tufts University School of Dental Medicine Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Vertical Bone Height intrasurgical clinical measurement in millimeter from 6 months to 8 months following the procedure
Secondary Rate of Post-Operative Complications compare the rate of post-operative complications over the six months healing period after vertical augmentation procedures Up to 6 months to 8 months following the procedure
Secondary Bone Core Histology Histomorphometric measurements of the tissue fractions (newly formed bone, DBBM, autogenous bone, and marrow and/or connective tissue) will be performed for the grafted area. from 6 months to 8 months following the procedure
See also
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Completed NCT05290376 - Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture N/A