Comparing the Efficacy and Morbidity of Two Vertical Ridge Augmentation Techniques

Running, not enrolling · Not applicable

Conditions studied: Vertical Alveolar Bone Loss

In brief

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.

Key facts

Study ID

NCT02703480

Run by

Tufts University

People needed

11

Starts

2015-12-01

Expected to finish

2025-06-01

Last updated by the study team

2024-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age or older
• Non-smokers
• Existence of bilateral vertical/horizontal ridge deformities (Seibert Class III)
• The length of the edentulous span is from two or more teeth

You may not qualify if…

• The patients will not be admitted in the study if any of the following exclusion criteria are met:
• Patients who have an infectious disease (self reported - HIV, tuberculosis or hepatitis)
• Known allergies to the research-related materials
• Patients who have compromised healing potential:
• bone metabolic disease e.g., Paget's disease, osteoporosis, osteomalacia
• uncontrolled diabetes: HbA1c >=7, values measured within six months (using the existing record in AxiUm or if the subject has the condition, but there is no report in AxiUm - a blood test record will be requested)
• patient currently taking steroid medication
• history of oral bisphosphonate intake greater than 3 years or any IV administration
• Pregnant or lactating patients (self-reported), as part of TUSDM standard of care not to treat for non-emergency surgical procedures
• Presence of surgical scar tissue from previous surgical procedure in the posterior mandible
• Pathology present within the alveolar ridges in the posterior mandible, determined clinically or radiographically
• History of radiation therapy to the mandible
• Smokers
• Elective periodontal procedures are postponed during pregnancy, active infectious disease, bisphosphonate intake or uncontrolled diabetes as standard of care in the TUSDM department of periodontology. Diseases or conditions which have been shown to affect healing are excluded for research. Vertical ridge augmentation is not contraindicated with pregnancy and there is no known safely issues associated with it.

Where it is running

• Tufts University School of Dental Medicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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