Tooth Loss
Conditions
Keywords
Ceramic implant
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.
Interventions
DEVICEFullCeram implant
FullCeram implantation
Sponsors
Institut Straumann AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Implant Survival | Measured at 12 months +/- 4 weeks after implant placement | A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Implant Success | Measured at Week 26, Month 12, Month 24 and Month 36 | 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) | Measured at Week 26, Month 12, Month 24 and Month 36 | 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 | Measured at Week 26, Month 24 and Month 36 | A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FullCeram Implant 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 | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | FullCeram Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 14 |
| Region of Enrollment Germany | 44 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 44 |
| serious Total, serious adverse events | 5 / 44 |
Outcome results
Primary
The Implant Survival
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
Population: Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FullCeram Implant | The Implant Survival | 97.6 percentage of participants |
Secondary
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.
Time frame: Measured at Week 26, Month 12, Month 24 and Month 36
Population: Standardised bone level measurements provided for the ITT population. Missing data were not imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FullCeram Implant | Mean Bone Level Changes (Distal and Mesial) | Month 12 (n=39) | -1.02 mm | Standard Deviation 0.9 |
| FullCeram Implant | Mean Bone Level Changes (Distal and Mesial) | Week 26 (n=39) | -0.88 mm | Standard Deviation 0.86 |
| FullCeram Implant | Mean Bone Level Changes (Distal and Mesial) | Month 24 (n=38) | -1.24 mm | Standard Deviation 0.94 |
| FullCeram Implant | Mean Bone Level Changes (Distal and Mesial) | Month 36 (n=37) | -0.97 mm | Standard Deviation 0.88 |
Secondary
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
Time frame: Measured at Week 26, Month 12, Month 24 and Month 36
Population: Implant success rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FullCeram Implant | The Implant Success | Week 26 (n=43) | 93.0 percentage of participants |
| FullCeram Implant | The Implant Success | Month 12 (n=42) | 97.6 percentage of participants |
| FullCeram Implant | The Implant Success | Month 24 (n=41) | 95.1 percentage of participants |
| FullCeram Implant | The Implant Success | Month 36 (n=40) | 97.5 percentage of participants |
Secondary
The Implant Survival
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
Population: Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FullCeram Implant | The Implant Survival | Week 26 (n= 43) | 97.7 percentage of participants |
| FullCeram Implant | The Implant Survival | Month 24 (n= 41) | 97.6 percentage of participants |
| FullCeram Implant | The Implant Survival | Month 36 (n= 40) | 97.5 percentage of participants |