Status:
COMPLETED
Comparison of Incidence Between Two Techniques
Lead Sponsor:
Tufts University
Conditions:
Edentulous Posterior Maxilla
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sinus augmentation, also referred to as a sinus lift or a sinus graft, is an oral surgery procedure where bone is added to the upper jaw near the molars. The goal of the surgery is to add enough bone ...
Detailed Description
Experimental Design The proposed study design is a single site, double armed, randomized clinical trial. Subjects will be those whose diagnosis requires restoring the lateral maxillary edentulous are...
Eligibility Criteria
Inclusion
- 18 years of age or older
- patients treatment planned for sinus lift augmentation and implant placement, with a height of the crestal alveolar bone measured in the middle of the edentulous space between four and six mm (calibrated measurements recorded on existing panoramic radiograph)
- the length of the edentulous span is one or two teeth
- non-smokers
Exclusion
- patients who have had a previous sinus lift augmentation procedure
- pathology present within the sinus (sinusitis, polyps, neoplasia, mucoceles, etc.) or any deformity/radiation therapy to the sinus
- medically compromised patients contraindicated to dental surgery at TUSDM periodontal clinic including uncontrolled diabetes (HbA1c ≥7, lab results from within the past 6 months will be reviewed, patient without lab results from within the past 6 months will be excluded) and/or uncontrolled hypertension (more than stage II, ≥160/110)
- patients with medical condition that could potentially affect wound healing (e.g., self-reported Hepatitis B or C, self-reported HIV)
- patients with metabolic bone disease such as Paget's Disease or osteoporosis
- patients who are currently taking bisphosphonates or steroids
- patients who are currently pregnant according to self-report (standard of care in the TUSDM Periodontology clinic for such procedures)
- current smokers
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01832025
Start Date
March 1 2013
End Date
December 1 2016
Last Update
September 24 2018
Active Locations (1)
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1
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111