Back to resultsImplant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
Primary Purpose
Tooth Loss
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
BLT Implant Ø 2.9 mm
Sponsored by
About this trial
This is an interventional other trial for Tooth Loss focused on measuring Small diameter implant
Eligibility 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.
Sites / Locations
- Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen
- Medi+
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
- Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie
- Kieferchirurgische Praxen Hentschel & Herrmann
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BLT Implant Ø 2.9 mm
Arm Description
The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.
Outcomes
Primary Outcome Measures
Implant Survival Rate at 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
Pink Esthetic Score (PES) at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02699866
Brief Title
Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
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 Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Small diameter implant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BLT Implant Ø 2.9 mm
Arm Type
Experimental
Arm Description
The Straumann BLT Implants Ø 2.9 mm are available with a length of 10, 12 and 14 mm.
Intervention Type
Device
Intervention Name(s)
BLT Implant Ø 2.9 mm
Other Intervention Name(s)
Short Diameter Implant (SDI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Implant Survival Rate at 12 Months After Implant Placement
Description
A "surviving implant" is an implant stably inserted in the subject's jaw bone at the time of assessment.
Time Frame
12 months after implant placement
Secondary Outcome Measure Information:
Title
Pink Esthetic Score (PES) at 6 Months After Implant Placement
Description
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.
Time Frame
6 months after implant placement
Other Pre-specified Outcome Measures:
Title
Implant Success Rate at 12 Months After Implant Placement
Description
A "successful implant" is an implant where all of the following success criteria (according to Buser et al., 1992) apply:
Absence of persisting subjective discomfort such as pain, foreign body perception and/or dysesthesia (painful sensation);
Absence of recurrent peri-implant infection with suppuration;
Absence of tactile implant mobility;
Absence of a continuous peri-implant radiolucency.
Time Frame
12 months after implant placement
Title
Marginal Bone Level Changes at 12 Months After Implant Placement
Description
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.
Time Frame
Baseline and 12 months after implant placement
Title
Incidence of Adverse Events and Adverse Device Effects
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Sagheb, Dr.
Organizational Affiliation
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kieferchirurgische Gemeinschaftspraxis Dr. Dr. Stroink & Kollegen
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Medi+
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Mund-Kiefer-Gesichtschirurgie, Plastische Operationen
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Mund-, Kiefer- und Gesichtschirurgie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Kieferchirurgische Praxen Hentschel & Herrmann
City
Zwickau
ZIP/Postal Code
08056
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10337309
Citation
Steinemann SG. Titanium--the material of choice? Periodontol 2000. 1998 Jun;17:7-21. doi: 10.1111/j.1600-0757.1998.tb00119.x. No abstract available.
Results Reference
background
PubMed Identifier
20586785
Citation
Gottlow J, Dard M, Kjellson F, Obrecht M, Sennerby L. Evaluation of a new titanium-zirconium dental implant: a biomechanical and histological comparative study in the mini pig. Clin Implant Dent Relat Res. 2012 Aug;14(4):538-45. doi: 10.1111/j.1708-8208.2010.00289.x. Epub 2010 Jun 25.
Results Reference
background
PubMed Identifier
7593037
Citation
Kobayashi E, Matsumoto S, Doi H, Yoneyama T, Hamanaka H. Mechanical properties of the binary titanium-zirconium alloys and their potential for biomedical materials. J Biomed Mater Res. 1995 Aug;29(8):943-50. doi: 10.1002/jbm.820290805.
Results Reference
background
PubMed Identifier
21414131
Citation
Al-Nawas B, Bragger U, Meijer HJ, Naert I, Persson R, Perucchi A, Quirynen M, Raghoebar GM, Reichert TE, Romeo E, Santing HJ, Schimmel M, Storelli S, ten Bruggenkate C, Vandekerckhove B, Wagner W, Wismeijer D, Muller F. A double-blind randomized controlled trial (RCT) of Titanium-13Zirconium versus Titanium Grade IV small-diameter bone level implants in edentulous mandibles--results from a 1-year observation period. Clin Implant Dent Relat Res. 2012 Dec;14(6):896-904. doi: 10.1111/j.1708-8208.2010.00324.x. Epub 2011 Mar 17.
Results Reference
background
PubMed Identifier
24015975
Citation
Benic GI, Gallucci GO, Mokti M, Hammerle CH, Weber HP, Jung RE. Titanium-zirconium narrow-diameter versus titanium regular-diameter implants for anterior and premolar single crowns: 1-year results of a randomized controlled clinical study. J Clin Periodontol. 2013 Nov;40(11):1052-61. doi: 10.1111/jcpe.12156. Epub 2013 Sep 8.
Results Reference
background
PubMed Identifier
24666383
Citation
Al-Nawas B, Domagala P, Fragola G, Freiberger P, Ortiz-Vigon A, Rousseau P, Tondela J. A Prospective Noninterventional Study to Evaluate Survival and Success of Reduced Diameter Implants Made From Titanium-Zirconium Alloy. J Oral Implantol. 2015 Aug;41(4):e118-25. doi: 10.1563/AAID-JOI-D-13-00149. Epub 2014 Mar 25.
Results Reference
background
PubMed Identifier
24713048
Citation
Quirynen M, Al-Nawas B, Meijer HJ, Razavi A, Reichert TE, Schimmel M, Storelli S, Romeo E; Roxolid Study Group. Small-diameter titanium Grade IV and titanium-zirconium implants in edentulous mandibles: three-year results from a double-blind, randomized controlled trial. Clin Oral Implants Res. 2015 Jul;26(7):831-40. doi: 10.1111/clr.12367. Epub 2014 Apr 9.
Results Reference
background
PubMed Identifier
24660189
Citation
Klein MO, Schiegnitz E, Al-Nawas B. Systematic review on success of narrow-diameter dental implants. Int J Oral Maxillofac Implants. 2014;29 Suppl:43-54. doi: 10.11607/jomi.2014suppl.g1.3.
Results Reference
background
PubMed Identifier
15635943
Citation
Hammerle CH, Chen ST, Wilson TG Jr. Consensus statements and recommended clinical procedures regarding the placement of implants in extraction sockets. Int J Oral Maxillofac Implants. 2004;19 Suppl:26-8. No abstract available.
Results Reference
background
PubMed Identifier
3507627
Citation
Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
Results Reference
background
PubMed Identifier
15635945
Citation
Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
Results Reference
background
PubMed Identifier
16307569
Citation
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
Results Reference
background
PubMed Identifier
19681932
Citation
Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x.
Results Reference
background
Links:
URL
https://www.mah.se/CAPP/Methods-and-Indices/Oral-Hygiene-Indices/Silness-Loe-Index/.
Description
Silness J, Loe H. 196, available at
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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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