Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Different Transcrestal Sinus Floor Elevation
NCT ID: NCT02953392
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2016-05-10
2022-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Transcrestal Sinus Floor Elevation using platform switched implant with bone graft material.
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.
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.
Arm 2
Transcrestal Sinus Floor Elevation using platform switched implant with no bone graft material.
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.
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.
Arm 3
Transcrestal Sinus Floor Elevation using platform matching implant with bone graft material.
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.
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.
Arm 4
Transcrestal Sinus Floor Elevation using platform matching implant with no bone graft material.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects must be 18 to 70 years of age.
3. Subjects must be able and willing to follow study procedures and instructions.
4. Subject must maintain good oral hygiene.
5. 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).
6. 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.
7. No apical disorder/inflammation at the area of the implant site.
8. Residual bone height ranging from 6 to 9 mm.
9. The implant must penetrate at least 2 mm into the sinus on the mesial or distal sides.
10. Sufficient bone width in the edentulous region (≥ 6mm).
11. Subjects must be committed to the study and attend the required follow-up visits.
Exclusion Criteria
2. Subjects who have failed to maintain good plaque control.
3. Subjects with any contraindications for oral surgical procedures (e.g. inadequate wound healing capacity, poor oral hygiene, maxillary and mandibular growth not completed, xerostomia).
4. Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site.
5. Subjects presenting with maxillary sinus pathology.
6. Subjects with a history of local irradiation therapy in the head/neck region.
7. Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction.
8. Subjects receiving, or having a history of receiving intravenous or subcutaneous antiresorptive agents associated with osteonecrosis of the jaw, such as bisphosphonates.
9. Oblique sinus floor (\> 45 inclination).
10. Subjects with any untreated endodontic lesions or untreated periodontal disease.
11. Subjects who are heavy smokers (defined as \>10 cigarettes per day or \>1 cigar per day) or chew tobacco, including within 3 months prior to enrollment.
12. Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene.
13. Subjects who are pregnant or intending to become pregnant during the duration of the study.
14. Subjects requiring bone augmentation or socket grafting prior to surgery.
15. Subject allergic to collagen or porcine derived products.
16. Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non- compliance or unreliability.
18 Years
70 Years
ALL
Yes
Sponsors
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NYU College of Dentistry
OTHER
Responsible Party
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Ismael Khouly
Associate Director of Periodontology & Implant Dentistry
Principal Investigators
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Ismael E Khouly, DDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
Bluestone Center for Clinical Research
Locations
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Bluestone Center for Clinical Research
New York, New York, United States
Countries
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Other Identifiers
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15-01349
Identifier Type: -
Identifier Source: org_study_id
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