Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Transcrestal Sinus Floor Elevation using platform switched implant with bone graft material. |
|
| Arm 2 | Active Comparator | Transcrestal Sinus Floor Elevation using platform switched implant with no bone graft material. |
|
| Arm 3 | Active Comparator | Transcrestal Sinus Floor Elevation using platform matching implant with bone graft material. |
|
| Arm 4 | Active Comparator | Transcrestal Sinus Floor Elevation using platform matching implant with no bone graft material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anorganic Bovine Bone Graft Material | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean crestal bone level changes measured in mm using periapical radiographs and CT scans. | Mean crestal bone level change around the implants will be determined by periapical radiographs of mesial and distal bone levels. CT scans will be used to determine buccal and lingual bone level change between implant placement and 12 months, following placement of a platform switched implants or platform matching implants. | 12 months |
| Mean periapical sinus bone level changes measured in mm using periapical radiographs and CT scans. | Mean periapical sinus bone level change between implant placement and 12 months will be determined by radiographic measurement (using periapical radiographs and CT scans) following placement of a platform switched implant or platform matching implant in the posterior region of the maxilla, with bone graft material or without bone graft material. | 12 months |
| Implant survival measured through observation. | Implant survival will be measured at implant loading and 12 months following implant placement will be assessed through clinical observation. | 12 months |
| Implant success rate measured by percentage. | Implant success rate will be assessed at implant loading and 12 months following implant placement measured by percentage. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal bone height changes measured in mm using periapical radiographs. | Additional crestal bone height change determined by measurements of periapical radiographs of mesial and distal bone levels between implant placement and implant loading, and between implant loading and 12 months post-implant placement. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ismael E Khouly, DDS, MS, PhD | Bluestone Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bluestone Center for Clinical Research | New York | New York | 10010 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 12, 2024 | |
| Reset | Jan 7, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Collagen Membrane | Device | 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. |
|
| Shelta Platform Switching Premium Implants | Device | 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. |
|
| Shelta Platform Matching Premium Implants | Device | 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. |
|
| Implant Stability Quotient (ISQ) measured in N/cm. |
Implant Stability Quotient (ISQ) between implant placement and implant loading and at 6 months and between implant loading. |
| 6 months |
| Periodontal Pocket Depths measured in mm. | Periodontal Pocket Depths assessed at screening, implant loading, and 12 months post-implant placement. | 12 months |
| Subject satisfaction assessed through questionnaire. | Subject satisfaction at implant placement, immediate post-operative, and 12 months post-implant placement. | 12 months |
| Changes in sinus anatomy measured in mm compared to implant survival. | Changes in the sinus anatomy measured in mm compared to implant survival. | 12 months |
| Changes in sinus anatomy measured in mm compared to implant success. | Changes in the sinus anatomy measured in mm compared to implant success. | 12 months |
| Changes in sinus anatomy measured in mm compared to crestal bone changes. | Changes in the sinus anatomy measured in mm compared to crestal bone level changes. implant stability (ISQ). | 12 months |
| Changes in sinus anatomy measured in mm compared to implant stability. | Changes in the sinus anatomy measured in mm compared to implant stability (ISQ). | 12 months |
| Changes residual crestal bone height measured in mm compared to implant survival. | Changes in residual crestal bone height compared to implant survival. | 12 months |
| Changes residual crestal bone height measured in mm compared to implant success. | Changes in residual crestal bone height compared to implant success. | 12 months |
| Changes residual crestal bone height measured in mm compared to implant stability. | Changes in residual crestal bone height compared to implant stability (ISQ). | 12 months |
| Changes residual crestal bone height measured in mm compaierd to sinus bone levels. | Changes in residual crestal bone height compared to sinus bone levels. | 12 months |
| Bleeding on probing measured by present or not present. | Bleeding on probing assessed at screening, implant loading, and 12 months post-implant placement. | 12 months |
| Gingival Recession measured in mm. | Gingival recession assessed at screening, implant loading, and 12 months post-implant placement. | 12 months |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 12, 2024 | Jan 7, 2025 |
| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
Not provided
Not provided