Comparing the Efficacy and Morbidity of Two Vertical Ridge Augmentation Techniques (NCT02703480) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing the Efficacy and Morbidity of Two Vertical Ridge Augmentation Techniques
United States11 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 d…
What they're measuring
1
Changes in Vertical Bone Height
Timeframe: from 6 months to 8 months following the procedure