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Performance Evaluation of FullCeram Implants in Single Tooth Gaps

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ClinicalTrials.gov Identifier: NCT02163395
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Results First Posted : July 16, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Tooth Loss
Intervention Device: FullCeram implant
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

Period Title: Overall Study
Started 44
Completed 39
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             3
Adverse Event             1
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  90.9%
>=65 years
4
   9.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
48  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
27
  61.4%
Male
17
  38.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 44 participants
44
1.Primary Outcome
Title The Implant Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

Overall Number of Participants Analyzed 42
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.6
(86.6 to 99.9)
2.Secondary Outcome
Title The Implant Success
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Implant success rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 26 (n=43) Number Analyzed 43 participants
93.0
(80.7 to 98.3)
Month 12 (n=42) Number Analyzed 42 participants
97.6
(86.6 to 99.9)
Month 24 (n=41) Number Analyzed 41 participants
95.1
(83.0 to 99.5)
Month 36 (n=40) Number Analyzed 40 participants
97.5
(86.0 to 99.9)
3.Secondary Outcome
Title Mean Bone Level Changes (Distal and Mesial)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Standardised bone level measurements provided for the ITT population. Missing data were not imputed.
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mm
Week 26 (n=39) Number Analyzed 39 participants
-0.88  (0.86)
Month 12 (n=39) Number Analyzed 39 participants
-1.02  (0.90)
Month 24 (n=38) Number Analyzed 38 participants
-1.24  (0.94)
Month 36 (n=37) Number Analyzed 37 participants
-0.97  (0.88)
4.Secondary Outcome
Title The Implant Survival
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

Overall Number of Participants Analyzed 43
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 26 (n= 43) Number Analyzed 43 participants
97.7
(86.6 to 99.9)
Month 24 (n= 41) Number Analyzed 41 participants
97.6
(86.3 to 99.9)
Month 36 (n= 40) Number Analyzed 40 participants
97.5
(86.0 to 99.9)
Time Frame Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FullCeram Implant
Hide Arm/Group 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

FullCeram implant: FullCeram implantation

All-Cause Mortality
FullCeram Implant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FullCeram Implant
Affected / at Risk (%) # Events
Total   5/44 (11.36%)    
Blood and lymphatic system disorders   
Sepsis  [1]  1/44 (2.27%)  1
General disorders   
Hospitalization   1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Meniscus surgery   1/44 (2.27%)  1
Calcaneal spur   1/44 (2.27%)  1
Pregnancy, puerperium and perinatal conditions   
Birth of a boy   1/44 (2.27%)  1
Renal and urinary disorders   
Kidney infection   1/44 (2.27%)  1
Surgical and medical procedures   
Fracture  [1]  1/44 (2.27%)  1
Indicates events were collected by systematic assessment
[1]
not related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FullCeram Implant
Affected / at Risk (%) # Events
Total   33/44 (75.00%)    
Cardiac disorders   
Hypertonus   1/44 (2.27%)  1
General disorders   
Pain   18/44 (40.91%)  18
Headache   1/44 (2.27%)  1
Abdominal pain   1/44 (2.27%)  1
Accident   1/44 (2.27%)  1
Thyroid hypofunction   1/44 (2.27%)  1
Infections and infestations   
Adenovirus   1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Back pain   1/44 (2.27%)  1
Pocket formation and bone loss   1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Fibroma   1/44 (2.27%)  1
Chronic lymphocytic leukemia   1/44 (2.27%)  1
Melanoma   1/44 (2.27%)  1
Reproductive system and breast disorders   
Uterine abrasion   1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Cold, influenza or sore throat   8/44 (18.18%)  8
Chronic bronchitis   1/44 (2.27%)  1
Skin and subcutaneous tissue disorders   
Decrease of gingiva   1/44 (2.27%)  1
Surgical and medical procedures   
Bleeding, swelling, inflammation / infection   10/44 (22.73%)  10
Insufficient, loose or broken crown   8/44 (18.18%)  8
Implant success criteria not fulfilled   3/44 (6.82%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Intsitut Straumann AG
Organization: Clinical Research
Phone: 0041619651111
Publications:
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.
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT02163395     History of Changes
Other Study ID Numbers: CR 01/07
First Submitted: June 10, 2014
First Posted: June 13, 2014
Results First Submitted: May 18, 2015
Results First Posted: July 16, 2015
Last Update Posted: December 4, 2018