NCT02953392

Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Different Transcrestal Sinus Floor Elevation

Evaluation of Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Two Different Transcrestal Sinus Floor Elevation Approaches: A Multi-Center, Double Blind, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: NYU College of Dentistry · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 60 subjects who require at least one posterior maxilla implant in the areas of the second pre-molars or (first or second) molars with 6 to 9 mm of crestal bone below the sinus floor, as determined on the computerized axial tomographic (CT) scan, will be recruited for the study. Subjects will receive dental implants to replace a missing tooth (second pre-molar or first/second molar) on one side of the maxillary arch. Each subject will receive one type of implant: platform switched (PS) or platform matching (PM). Each site will receive either a bone graft material composed of anorganic bovine bone mineralized (ABBM, Bio-Oss, Geistlich Pharma) or no graft material (collagen membrane used for wound healing (Collatape, Zimmer)). At implant placement surgery and post-surgical follow-ups, the treated site will be examined, clinically measured, and radiographs and photographs will be taken. The central hypothesis is that the mean crestal bone level for the platform switched (test implants) implants will be superior to the mean crestal bone level for the platform matching (control implants) implants when placed in limited maxillary residual bone in the posterior regions, regardless of the use of bone graft material or collagen membrane.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
DEVICE	Anorganic Bovine Bone Graft Material	Anorganic bovine bone graft material is intended for augmentation or reconstructive treatment of the alveolar ridge, filling periodontal defects, filling defects after root resection, apicoectomy, and cystectomy, filling extraction sockets to enhance preservation of the alveolar ridge, and elevation of maxillary sinus floor.
DEVICE	Collagen Membrane	Collagen dental wound dressing is intended for the management of oral wounds and sores, including; dental sores, oral ulcers, periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds.
DEVICE	Shelta Platform Switching Premium Implants	Shelta implant systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
DEVICE	Shelta Platform Matching Premium Implants	Shelta implant systems are intended for immediate placement and function on single tooth and /or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Timeline

• Start date: 2016-05-10
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2016-11-02
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States