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

August 5, 2021 updated by: Institut Straumann AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40210
        • Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen
      • Mainz, Germany, 55128
        • Medi+
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
      • Münster, Germany, 48149
        • Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie
      • Zwickau, Germany, 08056
        • Kieferchirurgische Praxen Hentschel & Herrmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Short Diameter Implant (SDI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival Rate 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.
12 months after implant placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pink Esthetic Score (PES) at 6 Months After Implant Placement
Time Frame: 6 months after implant placement
The Pink esthetic score 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. The higher the value, the better the outcome.
6 months after implant placement

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Success Rate 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.
12 months after implant placement
Marginal Bone Level Changes at 12 Months After Implant Placement
Time Frame: Baseline and 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.
Baseline and 12 months after implant placement
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Straumann AG

Investigators

  • Principal Investigator: Keyvan Sagheb, Dr., Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR02/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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