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Performance Evaluation of FullCeram Implants in Single Tooth Gaps

Primary Purpose

Tooth Loss

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FullCeram implant
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tooth Loss focused on measuring Ceramic implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must have voluntary signed the informed consent and the data protection consent form before any study related action
  • Males and females with at least 18 years of age (including 18 years)
  • Implant placement planned in the maxilla or mandible
  • The missing tooth site must have a tooth with a natural root
  • Substantially healed and augmented extraction sockets (minimal 8 weeks)
  • Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position

Exclusion Criteria:

Pre-surgical exclusion criteria:

  • Systemic disease that would interfere with dental implant therapy
  • Any contraindications for oral surgical procedures
  • Mucosal diseases
  • History of local irradiation therapy
  • Current untreated periodontitis or gingivitis
  • Any untreated endodontic lesions
  • Probing pocket depth of > or = 4 mm on one of the teeth immediately adjacent to the dental implant site
  • Severe bruxing or clenching habits
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
  • Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
  • 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
  • Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
  • Pregnant women at screening

Secondary exclusion criteria at or after implant surgery:

  • Lack of primary stability of the implant (hand testing directly after surgery)
  • Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration)
  • Major simultaneous augmentation procedures (at surgery)
  • X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)

Sites / Locations

  • Medizinische Hochschule Hannover Klinik und Poliklinik fuer Mund-, Kiefer- und Gesichtschirurgie
  • Oralchirurgie T1
  • Katharinenhospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FullCeram implant

Arm Description

Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm

Outcomes

Primary Outcome Measures

The Implant Survival
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.

Secondary Outcome Measures

The Implant Success
According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply. Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation) Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics) Absence of implant mobility on manual palpation Absence of any continuous peri-implant radiolucency
Mean Bone Level Changes (Distal and Mesial)
A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.
The Implant Survival
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.

Full Information

First Posted
June 10, 2014
Last Updated
May 16, 2022
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT02163395
Brief Title
Performance Evaluation of FullCeram Implants in Single Tooth Gaps
Official Title
A Prospective Open Label Single Arm Study to Evaluate the Performance of Straumann Monotype FullCeram (Zirconium Dioxide) Implants in Single Tooth Gaps in the Maxilla and Mandible
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2011 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2023 (Anticipated)

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
Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year
Detailed Description
This is a prospective, open label, single arm, multicenter study. The total study duration for each patient was prolonged to 10 years follow-up. It is acceptable to have the visit performed up to 6 month after the aspired date. The primary study parameter will be analyzed as soon as every patient passed visit 6 (annual follow-up visit, 12 month +/- 4 weeks). Implants will be placed transmucosally and will be protected by a thermoplastic splint for healing. A provisional prosthesis will be placed (out of occlusion) 12-14 weeks post implant placement. The final crown will be done between study week 24 and 28. Implant survival, implant success, bone loss, periodontal parameters and adverse events will be assessed in the follow-up visits. In total 10 visits are scheduled in this study. The investigational device: Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm. This is a CE marked product. Three centres in Germany are participating. The study and any amendments will be performed as far as possible according to ISO 14155 (Second Edition, 2011-02-01) and conform to the Declaration of Helsinki (last revised Seoul 2008) 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
Ceramic 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
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FullCeram implant
Arm Type
Other
Arm Description
Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm
Intervention Type
Device
Intervention Name(s)
FullCeram implant
Other Intervention Name(s)
Straumann Monotype FullCeram (Zirconium dioxide)
Intervention Description
FullCeram implantation
Primary Outcome Measure Information:
Title
The Implant Survival
Description
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
Time Frame
Measured at 12 months +/- 4 weeks after implant placement
Secondary Outcome Measure Information:
Title
The Implant Success
Description
According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply. Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation) Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics) Absence of implant mobility on manual palpation Absence of any continuous peri-implant radiolucency
Time Frame
Measured at Week 26, Month 12, Month 24 and Month 36
Title
Mean Bone Level Changes (Distal and Mesial)
Description
A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.
Time Frame
Measured at Week 26, Month 12, Month 24 and Month 36
Title
The Implant Survival
Description
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
Time Frame
Measured at Week 26, Month 24 and Month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must have voluntary signed the informed consent and the data protection consent form before any study related action Males and females with at least 18 years of age (including 18 years) Implant placement planned in the maxilla or mandible The missing tooth site must have a tooth with a natural root Substantially healed and augmented extraction sockets (minimal 8 weeks) Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position Exclusion Criteria: Pre-surgical exclusion criteria: Systemic disease that would interfere with dental implant therapy Any contraindications for oral surgical procedures Mucosal diseases History of local irradiation therapy Current untreated periodontitis or gingivitis Any untreated endodontic lesions Probing pocket depth of > or = 4 mm on one of the teeth immediately adjacent to the dental implant site Severe bruxing or clenching habits Patients with inadequate oral hygiene or unmotivated for adequate home care Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study 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 Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene Pregnant women at screening Secondary exclusion criteria at or after implant surgery: Lack of primary stability of the implant (hand testing directly after surgery) Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration) Major simultaneous augmentation procedures (at surgery) X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gahlert, Prof Dr Dr
Organizational Affiliation
Oralchirurgie T1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Hochschule Hannover Klinik und Poliklinik fuer Mund-, Kiefer- und Gesichtschirurgie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Oralchirurgie T1
City
Munich
ZIP/Postal Code
80333
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Lambrecht TJ, Filipi A, Raetzer Luenzel A, Schiel HJ. Long-Term evaluation of submerged and nonsubmerged ITI solid-screw titanium implants. A 10-year life table analysis of 468 implants. Int J Oral Maxifollofac Implants; 18:826-834, 2003. Kohal R J, et al. Loaded custom-made zirconia and titanium implants show similar osseointegration: an animal experiment. J Periodontol. 75.9, 1262-68, 2004. Scarano A, et al. Bone response to zirconia ceramic implants: an experimental study in rabbits. J Oral Implantol. 8-12, 29.1, 2003. Sennerby L, at al. Bone tissue resonses to surface-modified zirconia implants: A histomorphometric and removal torque study in the rabbit. Clin. Implant. Dent.Relat Res. 7 Suppl: S13-S20, 2005. Blaschke C, and Volz U. Soft and hard tissue response to zirconium dioxide dental implants - a clinical study in man. Neuro.Endocrinol.Lett. 27.Suppl1, 2006. Olivia J, Olivia X, Olivia JD. One year follow-up of first consecutive 100 Zirconia Dental Implants in humans: A comparison of 2 different rough surfaces. Int J Oral Maxillofac Implants; 22:430-435, 2007. Herrmann JS, Buser D, Schenk RK, Schoolfield JD, Cochran DL. Biologic width around one-and two-piece titanium implants. A histometric evaluation of unloaded nonsubmerged and submerged implants in the canine mandible. Clin Oral Impl Res 12, 559-571, 2001. Todescan FF, Pustiglioni FE, Imbronito AV, Albrektson T, Gioso M. Influenze of the microgap in the peri-implant hard and soft tissues. A histomorphometric study in dogs. Int J Pral Maxillofac Implants 17:467-472, 2002. Buser D, Weber HP, Braegger U, Balsinger C. Gewebeintegration einphasiger ITI-Implantate: Drei-Jahres-Ergebnisse einer prospektiven Langzeitstudie mit Hohlzylinder- und Hohlschraubenimplantaten. Buser D, Martin W, Belser UC. Optimizing Esthetics for Implant restorations in the Anterior Maxilla: Anatomic and Surgical Considerations. Int. J Oral and Maxillofacial Implants. Supplement; 19:43-61, 2004.
Results Reference
background
PubMed Identifier
30382850
Citation
Bormann KH, Gellrich NC, Kniha H, Schild S, Weingart D, Gahlert M. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth edentulous area: 3-year follow-up. BMC Oral Health. 2018 Nov 1;18(1):181. doi: 10.1186/s12903-018-0636-x.
Results Reference
derived

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Performance Evaluation of FullCeram Implants in Single Tooth Gaps

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