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Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting

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ClinicalTrials.gov Identifier: NCT02699866
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

Brief Summary:

The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow treatment of patients with single tooth gaps of small dimensions in the lateral and central incisor positions in the mandible and in the lateral incisor positions in the maxilla. These positions are reduced-load-bearing compared to more posterior positions.

During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.


Condition or disease Intervention/treatment Phase
Tooth Loss Device: BLT Implant Ø 2.9 mm Not Applicable

Detailed Description:

This is a multi-center, prospective, single cohort, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 12 ± 1 months.

Straumann BLT implants Ø 2.9 mm will be placed in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement, followed by provisional prosthetic loading after 6 ± 2 weeks and by final prosthetic loading 4 ± 1 months after implant placements.

In total 7 visits per patient are scheduled in this study. Implant survival, PES, implant success, bone level changes and adverse events (AEs) will be assessed.

The investigational device is a CE-(Conformité Européenne, meaning European Conformity) marked product. Straumann BLT implants Ø 2.9 mm Roxolid SLActive (sand blasted, large grit, acid etched surface) are available in lengths of 10, 12 and 14 mm.

Four centers in Germany will participate. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-Center, Prospective, Single Cohort, Post-Market Clinical Follow-Up (PMCF) Study to Assess Implant Survival After Insertion of Straumann® Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
Study Start Date : February 2016
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Experimental: BLT Implant Ø 2.9 mm
The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.
Device: BLT Implant Ø 2.9 mm
Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
Other Name: Short Diameter Implant (SDI)




Primary Outcome Measures :
  1. Implant survival at 12 months after implant placement [ Time Frame: 12 months after implant placement ]
    A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.


Secondary Outcome Measures :
  1. Pink esthetic score (PES) at 6 months after implant placement [ Time Frame: 6 months after implant placement ]
    The PES allows an objective evaluation of peri-implant soft tissue of single tooth implants based on 7 variables and is highly reproducible. Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. The minimum achievable PES is 0 and the maximum score is 14.


Other Outcome Measures:
  1. Implant success at 12 months after implant placement [ Time Frame: 12 months after implant placement ]

    A "successful implant" is an implant where all of the following success criteria (according to Buser et al., 1992) apply:

    1. Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation);
    2. Absence of recurrent peri-implant infection with suppuration;
    3. Absence of tactile implant mobility;
    4. Absence of a continuous peri-implant radiolucency.

  2. Marginal bone level changes at 12 months after implant placement [ Time Frame: 12 months after implant placement ]
    An independent expert is contracted to perform the bone level measurements from the X-rays. The vertical bone level is evaluated by measuring the distance from the implant shoulder to the first visible bone contact on the implant. Measurements are taken at the mesial and distal aspects of the implant, and an average value is calculated. Mean bone level changes are computed by subtracting the average bone level at 12 months after implant placement from the average bone level at baseline (implant placement). Hence, negative bone level changes are representing bone loss; vice versa positive changes representing bone gain. Measurements take into account distortion based on changes on the radiograph from the true dimension of the implant.

  3. Incidence of adverse events and adverse device effects [ Time Frame: Screening, Baseline, 7-14 days after implant placement, 6 weeks after implant placement, 4 months after implant placement, 6 months after implant placement and 12 months after implant placement ]
    At each visit the Investigator should determine if any adverse events occurred since the last study visit by speaking with the patient and reviewing any dental and medical records. These AEs, along with any AEs from the current study visit, should be documented and reported as described in Section 8 of the protocol. In addition the Investigator should evaluate the status of any ongoing AEs throughout the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.
  • Patients must be males or females who are a minimum of 18 years of age.
  • Patients with a minimum of 4 weeks history of edentulism in the study area, minimal interdental space and in need of a single tooth replacement with a dental implant central and lateral incisors in the mandible and lateral incisors in the maxilla (Federation Dentaire Internationale (FDI) positions 12, 22, 31, 32, 41 or 42).
  • Presence of natural tooth or implants adjacent to the study implant position (single tooth gap).
  • Patients with complete soft tissue coverage of the socket at implant placement.

Exclusion Criteria:

  • Patients with inadequate bone volume and / or quality or metabolic bone disorder.
  • Patients with local root remnants.
  • Patients with inadequate wound healing capacity.
  • Patients with not completed maxillary and mandibular growth.
  • Patients with serious internal medical problems, uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders.
  • Patients with poor general state of health.
  • Patients with drug or alcohol abuse.
  • Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy.
  • Patients 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.
  • A woman who is pregnant or planning to become pregnant at any point during the study duration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699866


Locations
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Germany
Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen
Düsseldorf, Germany, 40210
Medi+
Mainz, Germany, 55128
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
Mainz, Germany, 55131
Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie
Münster, Germany, 48149
Kieferchirurgische Praxen Hentschel & Herrmann
Zwickau, Germany, 08056
Sponsors and Collaborators
Institut Straumann AG
Investigators
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Principal Investigator: Keyvan Sagheb, Dr. Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen

Additional Information:
Publications:

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Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT02699866     History of Changes
Other Study ID Numbers: CR02/15
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institut Straumann AG:
Small diameter implant

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases