Trial Outcomes & Findings for A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants (NCT NCT00905840)
NCT ID: NCT00905840
Last Updated: 2016-03-30
Results Overview
Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material. The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
12 months
Results posted on
2016-03-30
Participant Flow
Participant milestones
| Measure |
Titan Grade IV Implant and Titan Zircon Implant
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
|
|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Titan Grade IV Implant and Titan Zircon Implant
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study to Treat Patients With Edentulous Mandibles With Two Straumann 3.3mm Diameter Bone Level Implants
Baseline characteristics by cohort
| Measure |
Two Bone Level Implants in Interforaminal Region
n=91 Participants
All patients received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon alloy. All implants were 3.3 mm in Ø, had a similar macro- and micro-structure, and had the chemically modified SLActive (Sand blasted Large grid Acid-etched) surface.
The implants were placed in the interforaminal region of the mandible, one implant in each side.
Implant placement was double-blinded as the implants are visually identical, and the study was unblinded after 12 month for the first analysis.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Intent To Treat (ITT) populaton consisted of all randomized patients who received implants and who underwent at least one efficacy assessment.
Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material. The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used.
Outcome measures
| Measure |
Titan Grade IV Implant
n=89 implants
split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
Titan Zirkon Implant
n=89 implants
split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
|---|---|---|
|
Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.
|
0.3 mm
Interval -0.31 to 0.56
|
0.1 mm
Interval -0.34 to 0.54
|
SECONDARY outcome
Timeframe: at 12, 24 and 36 months post surgeryPopulation: The analysis was determined as Intent To Treat (ITT). The study population consisted of each randomized patient who received the device.
split-mouth design Implant success and survival rate according the definition by Buser et al. 1990 are: * Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysaesthesia * Absence of a recurrent peri-implant infection with suppuration * Absence of mobility * Absence of a continuous radiolucency around the implant * Possibility for restoration
Outcome measures
| Measure |
Titan Grade IV Implant
n=89 implants
split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
Titan Zirkon Implant
n=89 implants
split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
|---|---|---|
|
Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990
survival and success rates at 12 month
|
84 implants
|
86 implants
|
|
Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990
survival and success rates at 24 month
|
79 implants
|
80 implants
|
|
Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990
survival and success rates at 36 month
|
73 implants
|
74 implants
|
SECONDARY outcome
Timeframe: after 12, 24, and 36 monthPopulation: The numbers represent subjects that are classified as Yes. mPI: if all 4 evaluated scores are 0 or 1, the mPI will be classified as No. If at least one score is 2 or 3, mPI will be classified as Yes. mSBI: if all evaluated scores are 0 or 1, mSBI will be classified as No. If at least one score is 2 or 3, mSBI will be classified as Yes.
Modified Plaque Index (mPI) and modified Sulcus Bleeding Index (mSBI) according to Mombelli at al. (1987). Assessment to be perform at four sites per implant: lingual, buccal, mesial, and distal. mPI: 0=no plaque detected, 1=plaque only recognized by running a probe across the smooth marginal surface of the implant, 2=plaque can be seen by the naked eye, 3=abundance of soft matter. mSBI: 0=no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant, 1=isolated bleeding spot visible, 2=blood forms a confluent red line on margin, 3=heavy or profuse bleeding. Safety evaluations including recording of all complications, adverse events (AEs), and serious adverse events SAEs). Each AE and SAE will be assessed for severity and its potential relationship to the study device.
Outcome measures
| Measure |
Titan Grade IV Implant
n=89 Participants
split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
Titan Zirkon Implant
n=89 Participants
split-mouth
Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
|---|---|---|
|
Soft Tissue and Safety Assessments
Plaque Index 12 month
|
20 participants
|
19 participants
|
|
Soft Tissue and Safety Assessments
Sulcus Beeding Index 12 month
|
10 participants
|
9 participants
|
|
Soft Tissue and Safety Assessments
Plaque Index 24 month
|
16 participants
|
18 participants
|
|
Soft Tissue and Safety Assessments
Sulcus Beeding Index 24 month
|
7 participants
|
9 participants
|
|
Soft Tissue and Safety Assessments
SulcusPlaque Index 36 month
|
20 participants
|
19 participants
|
|
Soft Tissue and Safety Assessments
Sulcus Beeding Index 36 month
|
14 participants
|
13 participants
|
Adverse Events
Two Bone Level Implants in Interforaminal Region
Serious events: 14 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Two Bone Level Implants in Interforaminal Region
n=91 participants at risk
Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
|---|---|
|
Reproductive system and breast disorders
New diagnosis breast cancer
|
1.1%
1/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
General disorders
Sudden Death
|
1.1%
1/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Osteomyelitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Cardiac disorders
Hypertension
|
1.1%
1/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Vascular disorders
Vein thrombosis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Injury, poisoning and procedural complications
Cervical fracture
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Vascular disorders
Aneurism
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Endocrine disorders
Thyroid neoplasm
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Partial knee replacement
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Sepsis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Nervous system disorders
Dementia
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Hip replacement
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Psychiatric disorders
Suicide attempt
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
Other adverse events
| Measure |
Two Bone Level Implants in Interforaminal Region
n=91 participants at risk
Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
|
|---|---|
|
Surgical and medical procedures
Abutment breakage
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Broken arm
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary infection
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Candidiasis
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Eye disorders
Cataract
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
General disorders
Chronic pain
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Psychiatric disorders
Chronic depression
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Costal fracture
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Damage of adjacent or opposing dentition
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Injury, poisoning and procedural complications
Denture damage due to accident
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
General disorders
Fever
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Framework fracture
|
9.9%
9/91 • Number of events 9 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
General disorders
Granuloma
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Ear and labyrinth disorders
Hearing loss
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Infection mycotic
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Gastrointestinal disorders
Infectious colitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
General disorders
Leukoplakia oral
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Loosing of a prosthetic component
|
4.4%
4/91 • Number of events 4 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Minor inflammation during the healing process at implant site
|
5.5%
5/91 • Number of events 5 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Moderate periimplant infection
|
3.3%
3/91 • Number of events 3 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Myositis on leg
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Opposing framework fracture
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Other minor discomforts due to surgical procedure
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Peridontitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Vascular disorders
Phlebitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Prostatitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Radiolucency around implant
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Stomatitis
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Musculoskeletal and connective tissue disorders
Tactile horizontal or vertical implant mobility
|
5.5%
5/91 • Number of events 5 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Tooth removal
|
3.3%
3/91 • Number of events 3 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Transfer piece fracture
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Metabolism and nutrition disorders
Worsening diabetes mellitus
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Infections and infestations
Wound healing delayed
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Blood and lymphatic system disorders
Abdominal aortic aneurism
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Injury, poisoning and procedural complications
Osteomyelitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Renal and urinary disorders
Cystitis
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Suture removal
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Surgical uncovering of implant
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Spinal operation
|
1.1%
1/91 • Number of events 1 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Surgical and medical procedures
Prosthesis maintenance
|
3.3%
3/91 • Number of events 3 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
|
Cardiac disorders
Hypertension
|
2.2%
2/91 • Number of events 2 • Adverse Event (AE) data were collected 4 weeks after informed consent taken. At visit #2, then at Visit #3; 1-2 weeks after visit #2. 5-6 weeks after visit#3 and 2 weeks after visit #4. Then at 6, 12, 24, and 23 month follow up visits after visit #2.
|
Additional Information
Prof. Dr. Dr Bilal Al-Nawas, Principal Investigator
Johannes-Gutenberg-University Mainz
Phone: 0049 6131 17
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place