Jaw, Edentulous, Jaw, Edentulous, Partially
Conditions
Brief summary
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
Detailed description
This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months. In total 8 visits per patient are scheduled in this study. The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication. One center in Beligum will participate.
Interventions
DEVICEStraumann BoneCeramic
Bone augmentation procedure performed with Bone Ceramic
DEVICEBio-Oss
Bone Augmentation procedure performed with Bio Oss
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, 18 years to 80 years of age * At least two missing teeth up to full edentulous arches. * Desiring implant supported restorations. * Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect). * At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone. * Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved; * Patients must be committed to the study and must sign informed consent. * Patient in good general health as documented by self assessment; * Full mouth plaque score of \<20%;
Exclusion criteria
* Any systemic medical condition that could interfere with the surgical procedure or planned treatment; * Current pregnancy or breast feeding/ lactating at the time of recruitment; * Physical handicaps that would interfere with the ability to perform adequate oral hygiene; * Alcoholism or chronically drug abuse causing systemic compromise. * Patients who smoke more than 20 cigarettes per day. * Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability * Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly. * Mucosal diseases such as erosive lichen planus * History of local radiation therapy. * Presence of osseous pathologies. * Presence of oral lesions (such as ulceration, malignancy) * Severe bruxing or clenching habits. * Local inflammation, including untreated periodontitis. * Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement. * Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease. * Existing teeth in the residual dentition with untreated endodontic pathologies. * Patients with inadequate oral hygiene or unmotivated for adequate home care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Vertical Height of Buccal Defects | Baseline to 26 weeks | Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success Rate | 6 months | The success of oral implant will be determined according to the following parameters: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility (based on hand testing) * Absence of a peri-implant infection with suppuration. * 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). * Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection. |
| Implant Survival Rate | 6 Months | A surviving implant will be considered an implant fulfilling the following criteria: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility. * 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 pain or any other adverse observation by the patient, so that the implant has to be removed. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Straumann BoneCeramic and Geistlich Bio-Oss Each patient received both treatments in a split-mouth design. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Straumann BoneCeramic and Geistlich Bio-Oss |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment Belgium | 14 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 14 | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Change of Vertical Height of Buccal Defects
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
Time frame: Baseline to 26 weeks
Population: 14 patients represented the ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Straumann BoneCeramic | Change of Vertical Height of Buccal Defects | -4.5 mm |
| Geistlich Bio-Oss | Change of Vertical Height of Buccal Defects | -4.82 mm |
Secondary
Implant Success Rate
The success of oral implant will be determined according to the following parameters: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility (based on hand testing) * Absence of a peri-implant infection with suppuration. * 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). * Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Straumann BoneCeramic | Implant Success Rate | 100 % of implants |
| Geistlich Bio-Oss | Implant Success Rate | 100 % of implants |
Secondary
Implant Success Rate
The success of oral implant will be determined according to the following parameters: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility (based on hand testing) * Absence of a peri-implant infection with suppuration. * 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). * Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Straumann BoneCeramic | Implant Success Rate | 100 % of implants |
| Geistlich Bio-Oss | Implant Success Rate | 100 % of implants |
Secondary
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility. * 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 pain or any other adverse observation by the patient, so that the implant has to be removed.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Straumann BoneCeramic | Implant Survival Rate | 100 % of implants |
| Geistlich Bio-Oss | Implant Survival Rate | 100 % of implants |
Secondary
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria: * Absence of any continuous peri-implant radiolucency based on radiographic findings. * Absence of implant mobility. * 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 pain or any other adverse observation by the patient, so that the implant has to be removed.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Straumann BoneCeramic | Implant Survival Rate | 100 % of implants |
| Geistlich Bio-Oss | Implant Survival Rate | 100 % of implants |