Trial Outcomes & Findings for Survival and Success of MIS C1 Implants- a Field Study (NCT NCT01707108)

NCT ID: NCT01707108

Last Updated: 2021-06-15

Results Overview

1 year survival rate

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 1 year post implantation
• Results posted on: 2021-06-15

Participant Flow

Unit of analysis: Dental Implants

Participant milestones

Measure	Dental Implants Patients with missing teeth that are indicated for rehabilitation with Dental Implants (MIS Technologies) will be recruited. All the implants needed in the surgical area of the recruited patients will be allowed into the study Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants
Overall Study STARTED	60 117
Overall Study 1 Year	60 117
Overall Study COMPLETED	60 117
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Survival and Success of MIS C1 Implants- a Field Study

Baseline characteristics by cohort

Measure	Dental Implants n=117 implants Rehabilitation of missing teeth with Dental Implant (MIS Technologies) Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants
Age, Categorical <=18 years	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=60 Participants
Age, Categorical >=65 years	13 Participants n=60 Participants
Sex: Female, Male Female	32 Participants n=60 Participants
Sex: Female, Male Male	28 Participants n=60 Participants
Region of Enrollment Israel	60 participants n=60 Participants

PRIMARY outcome

Timeframe: 1 year post implantation

Population: Fifteen patients (25%) received 1 implant and 45 patients (75%) received 2 or more implants.

1 year survival rate

Outcome measures

Measure	Dental Implants n=117 dental implants Rehabilitation of missing teeth with Dental Implant (MIS Technologies) Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants
Survival Rate	115 dental implants

SECONDARY outcome

Timeframe: 1 year post implantation

Population: 117 implants in 60 patients

bone change in millimeters after 1 year

Outcome measures

Measure	Dental Implants n=117 dental implants Rehabilitation of missing teeth with Dental Implant (MIS Technologies) Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants
1 Year Implant Bone Level Changes	0.54 millimeters Standard Deviation 0.55

Adverse Events

Dental Implants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Trial

Rambam Health Care Campus

Phone: +97247772983

Email: j_horwitz@rambam.health.gov.il

Results disclosure agreements

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