Tooth LossNCT02953392
Implant-Abutment Interface Design on Bone and Soft Tissue Levels Around Implants Placed Using Different Transcrestal Sinus Floor Elevation
A study testing Anorganic Bovine Bone Graft Material, Collagen Membrane and Shelta Platform Switching Premium Implants in people with Tooth Loss, run by NYU College of Dentistry at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Anorganic Bovine Bone Graft Material, Collagen Membrane and Shelta Platform Switching Premium Implants
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bluestone Center for Clinical Research
New York, New York, 10010
About this study
Official title: 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
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.
Read the 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
- Being tested
- Anorganic Bovine Bone Graft Material, Collagen Membrane, Shelta Platform Switching Premium Implants, Shelta Platform Matching Premium Implants
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anorganic Bovine Bone Graft MaterialDevice
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 MembraneDevice
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 ImplantsDevice
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 ImplantsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Transcrestal Sinus Floor Elevation using platform switched implant with bone graft material. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Collagen Membrane; Device: Shelta Platform Matching Premium Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (14)
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.
Measured: 12 months
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.
Measured: 6 months
Periodontal Pocket Depths measured in mm.
Periodontal Pocket Depths assessed at screening, implant loading, and 12 months post-implant placement.
Measured: 12 months
Subject satisfaction assessed through questionnaire.
Subject satisfaction at implant placement, immediate post-operative, and 12 months post-implant placement.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 months
Changes residual crestal bone height measured in mm compared to implant survival.
Changes in residual crestal bone height compared to implant survival.
Measured: 12 months
Changes residual crestal bone height measured in mm compared to implant success.
Changes in residual crestal bone height compared to implant success.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 months
Gingival Recession measured in mm.
Gingival recession assessed at screening, implant loading, and 12 months post-implant placement.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start10 May 2016
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismael Khouly, NYU College of Dentistry
- Investigators
- Ismael E Khouly, DDS, MS, PhD, Principal investigator, Bluestone Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953392
- Sponsor's protocol ID
- 15-01349
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2016
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02953392
- Acronym / sponsor ID
- 15-01349
- Conditions
- Tooth Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NYU College of DentistryUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Anorganic Bovine Bone Graft Material, Device: Shelta Platform Switching Premium ImplantsTranscrestal Sinus Floor Elevation using platform switched implant with bone graft material. |
| Arm 2 | Active comparator | Device: Collagen Membrane, Device: Shelta Platform Switching Premium ImplantsTranscrestal Sinus Floor Elevation using platform switched implant with no bone graft material. |
| Arm 3 | Active comparator | Device: Anorganic Bovine Bone Graft Material, Device: Shelta Platform Matching Premium ImplantsTranscrestal Sinus Floor Elevation using platform matching implant with bone graft material. |
| Arm 4 | Active comparator | Device: Collagen Membrane, Device: Shelta Platform Matching Premium ImplantsTranscrestal Sinus Floor Elevation using platform matching implant with no bone graft material. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anorganic Bovine Bone Graft MaterialAnorganic 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 | Arm 1, Arm 3 |
| Collagen MembraneCollagen 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 | Arm 2, Arm 4 |
| Shelta Platform Switching Premium ImplantsShelta 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 | Arm 1, Arm 2 |
| Shelta Platform Matching Premium ImplantsShelta 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 | Arm 3, Arm 4 |
Primary outcome
Mean crestal bone level changes measured in mm using periapical radiographs and CT scans.
Time frame: 12 months
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.
Mean periapical sinus bone level changes measured in mm using periapical radiographs and CT scans.
Time frame: 12 months
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.
Implant survival measured through observation.
Time frame: 12 months
Implant survival will be measured at implant loading and 12 months following implant placement will be assessed through clinical observation.
Implant success rate measured by percentage.
Time frame: 12 months
Implant success rate will be assessed at implant loading and 12 months following implant placement measured by percentage.
14 secondary outcomes
Crestal bone height changes measured in mm using periapical radiographs.
Time frame: 12 months
Implant Stability Quotient (ISQ) measured in N/cm.
Time frame: 6 months
Periodontal Pocket Depths measured in mm.
Time frame: 12 months
Subject satisfaction assessed through questionnaire.
Time frame: 12 months
Changes in sinus anatomy measured in mm compared to implant survival.
Time frame: 12 months
Changes in sinus anatomy measured in mm compared to implant success.
Time frame: 12 months
Changes in sinus anatomy measured in mm compared to crestal bone changes.
Time frame: 12 months
Changes in sinus anatomy measured in mm compared to implant stability.
Time frame: 12 months
Changes residual crestal bone height measured in mm compared to implant survival.
Time frame: 12 months
Changes residual crestal bone height measured in mm compared to implant success.
Time frame: 12 months
Changes residual crestal bone height measured in mm compared to implant stability.
Time frame: 12 months
Changes residual crestal bone height measured in mm compaierd to sinus bone levels.
Time frame: 12 months
Bleeding on probing measured by present or not present.
Time frame: 12 months
Gingival Recession measured in mm.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismael E Khouly, DDS, MS, PhD principal investigator
Bluestone Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anorganic Bovine Bone Graft Material, Collagen Membrane and Shelta Platform Switching Premium Implants in people with Tooth Loss, run by NYU College of Dentistry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean crestal bone level changes measured in mm using periapical radiographs and CT scans. (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.