Trial Outcomes & Findings for Performance Evaluation of FullCeram Implants in Single Tooth Gaps (NCT NCT02163395)

NCT ID: NCT02163395

Last Updated: 2023-11-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Measured at 12 months +/- 4 weeks after implant placement
• Results posted on: 2023-11-22

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	44
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	3
Overall Study Adverse Event	1

Baseline Characteristics

Performance Evaluation of FullCeram Implants in Single Tooth Gaps

Baseline characteristics by cohort

Measure	FullCeram Implant n=44 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Germany	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	FullCeram Implant n=42 Participants 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
The Implant Survival	97.6 percentage of participants Interval 86.6 to 99.9

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	FullCeram Implant n=43 Participants 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
The Implant Success Week 26 (n=43)	93.0 percentage of participants Interval 80.7 to 98.3
The Implant Success Month 12 (n=42)	97.6 percentage of participants Interval 86.6 to 99.9
The Implant Success Month 24 (n=41)	95.1 percentage of participants Interval 83.0 to 99.5
The Implant Success Month 36 (n=40)	97.5 percentage of participants Interval 86.0 to 99.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	FullCeram Implant n=39 Participants 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
Mean Bone Level Changes (Distal and Mesial) Week 26 (n=39)	-0.88 mm Standard Deviation 0.86
Mean Bone Level Changes (Distal and Mesial) Month 12 (n=39)	-1.02 mm Standard Deviation 0.90
Mean Bone Level Changes (Distal and Mesial) Month 24 (n=38)	-1.24 mm Standard Deviation 0.94
Mean Bone Level Changes (Distal and Mesial) Month 36 (n=37)	-0.97 mm Standard Deviation 0.88

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	FullCeram Implant n=43 Participants 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
The Implant Survival Week 26 (n= 43)	97.7 percentage of participants Interval 86.6 to 99.9
The Implant Survival Month 24 (n= 41)	97.6 percentage of participants Interval 86.3 to 99.9
The Implant Survival Month 36 (n= 40)	97.5 percentage of participants Interval 86.0 to 99.9

Adverse Events

FullCeram Implant

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	FullCeram Implant n=44 participants at risk 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
Blood and lymphatic system disorders Sepsis	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Surgical and medical procedures Fracture	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Musculoskeletal and connective tissue disorders Meniscus surgery	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Pregnancy, puerperium and perinatal conditions Birth of a boy	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
General disorders Hospitalization	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Musculoskeletal and connective tissue disorders Calcaneal spur	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Renal and urinary disorders Kidney infection	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.

Other adverse events

Measure	FullCeram Implant n=44 participants at risk 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
General disorders Pain	40.9% 18/44 • Number of events 18 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Surgical and medical procedures Bleeding, swelling, inflammation / infection	22.7% 10/44 • Number of events 10 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Respiratory, thoracic and mediastinal disorders Cold, influenza or sore throat	18.2% 8/44 • Number of events 8 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Surgical and medical procedures Insufficient, loose or broken crown	18.2% 8/44 • Number of events 8 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Surgical and medical procedures Implant success criteria not fulfilled	6.8% 3/44 • Number of events 3 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Infections and infestations Adenovirus	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Musculoskeletal and connective tissue disorders Back pain	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Skin and subcutaneous tissue disorders Decrease of gingiva	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Musculoskeletal and connective tissue disorders Pocket formation and bone loss	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
General disorders Headache	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Cardiac disorders Hypertonus	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
General disorders Abdominal pain	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
General disorders Accident	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Respiratory, thoracic and mediastinal disorders Chronic bronchitis	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukemia	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
General disorders Thyroid hypofunction	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.
Reproductive system and breast disorders Uterine abrasion	2.3% 1/44 • Number of events 1 • Adverse events (AE) were reported from the time a patient provided written informed consent to the 36-month follow-up visit.

Additional Information

Intsitut Straumann AG

Clinical Research

Phone: 0041619651111

Email: research@straumann.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place