Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Dif… (NCT02953392) | Clinical Trial Compass
CompletedNot Applicable
Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Different Transcrestal Sinus Floor Elevation
United States38 participantsStarted 2016-05-10
Plain-language summary
Sixty patients with partially edentulous posterior maxilla requiring a transcrestal sinus floor elevation technique to insert one implant will be selected. The purpose of this multi-center, prospective, double blind, and randomized investigation is to analyze a platform switched implant when placed at limited maxillary residual bone height with low bone density compared to a platform matching implant with or without bone graft material.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects must have read, understood and signed an informed consent form.
✓. Subjects must be 18 to 70 years of age.
✓. Subjects must be able and willing to follow study procedures and instructions.
✓. Subject must maintain good oral hygiene.
✓. Subjects must have a single tooth missing in the pre-molar or molar region of the maxilla (ADA tooth positions 2-4 and 13-15; FDI tooth positions 15-17 and 25-27).
✓. The mesio-distal distance of the tooth gap at bone level must be at least 6.8 mm to allow for placement of the Ø3.8 mm implant with a minimal distance of 1.5 mm from the implant shoulder to the adjacent tooth at bone level. A minimum of 7.8 mm of buccal-lingual ridge to allow 2 mm of buccal and lingual plate will be required.
✓. No apical disorder/inflammation at the area of the implant site.
✓. Residual bone height ranging from 6 to 9 mm.
Exclusion criteria
✕. Subjects with a systemic disease that would preclude dental implant surgery (e.g. serious internal medical problems, disorders of bone metabolism, uncontrolled bleeding disorders, weakened immune system, illness requiring periodic use of steroids, uncontrollable endocrine disorders, uncontrolled diabetes).
✕. Subjects who have failed to maintain good plaque control.
✕. Subjects with any contraindications for oral surgical procedures (e.g. inadequate wound healing capacity, poor oral hygiene, maxillary and mandibular growth not completed, xerostomia).
What they're measuring
1
Mean crestal bone level changes measured in mm using periapical radiographs and CT scans.
Timeframe: 12 months
2
Mean periapical sinus bone level changes measured in mm using periapical radiographs and CT scans.
✕. Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site.
✕. Subjects presenting with maxillary sinus pathology.
✕. Subjects with a history of local irradiation therapy in the head/neck region.
✕. Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction.
✕. Subjects receiving, or having a history of receiving intravenous or subcutaneous antiresorptive agents associated with osteonecrosis of the jaw, such as bisphosphonates.