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

NCT02953392 | Completed DMC

• 1 other identifier: 15-01349
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (14)

• Crestal bone height changes measured in mm using periapical radiographs.

  12 months

• Implant Stability Quotient (ISQ) measured in N/cm.

  6 months

• Periodontal Pocket Depths measured in mm.

  12 months

• Subject satisfaction assessed through questionnaire.

  12 months

• Changes in sinus anatomy measured in mm compared to implant survival.

  12 months

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Transcrestal Sinus Floor Elevation using platform switched implant with bone graft material.

Device: Anorganic Bovine Bone Graft Material; Device: Shelta Platform Switching Premium Implants

Arm 2

ACTIVE COMPARATOR

Transcrestal Sinus Floor Elevation using platform switched implant with no bone graft material.

Device: Collagen Membrane; Device: Shelta Platform Switching Premium Implants

Arm 3

ACTIVE COMPARATOR

Transcrestal Sinus Floor Elevation using platform matching implant with bone graft material.

Device: Anorganic Bovine Bone Graft Material; Device: Shelta Platform Matching Premium Implants

Arm 4

ACTIVE COMPARATOR

Transcrestal Sinus Floor Elevation using platform matching implant with no bone graft material.

Device: Collagen Membrane; Device: Shelta Platform Matching Premium Implants

Interventions

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.

Arm 1; Arm 3

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.

Arm 2; Arm 4

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.

Arm 1; Arm 2

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.

Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The implant must penetrate at least 2 mm into the sinus on the mesial or distal sides.
• Sufficient bone width in the edentulous region (≥ 6mm).
• Subjects must be committed to the study and attend the required follow-up visits.

You may not qualify if:

• 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).
• 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.
• Oblique sinus floor (\> 45 inclination).
• Subjects with any untreated endodontic lesions or untreated periodontal disease.
• 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.
• Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene.
• Subjects who are pregnant or intending to become pregnant during the duration of the study.
• Subjects requiring bone augmentation or socket grafting prior to surgery.
• Subject allergic to collagen or porcine derived products.

Sponsors & Collaborators

• NYU College of Dentistry: lead

Study Sites (1)

Bluestone Center for Clinical Research

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Ismael E Khouly, DDS, MS, PhD

  Bluestone Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Periodontology & Implant Dentistry

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: November 2, 2016
• Study Start: May 10, 2016
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)