Evaluation of two different implant designs used for single tooth replacement and bridge reconstructions

Evaluation of two different implant designs used for single tooth replacement and bridge reconstructions - SICmax/SICace 001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007877

Enrollment

Registered

2015-03-06

Start date

2012-08-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K08.1

Interventions

Group 1: Implantation (SICace implants) Group 2: Implantation (SICmax implants)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • The subjects should be more than 18 years old. • The subject should be systemically healthy and have good compliance. • The subject should be in need of an implant supported partial denture (bridge) or implant supported single tooth restorations in the posterior region.

Exclusion criteria

Exclusion criteria: • Alcohol or drug abuse. • Psychiatric problems. • Infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoetic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e. uncontrolled diabetes), pregnancy, or local contraindications (i.e. tumors, ulcers etc) for dental surgery. • The subject is not able to give her/his informed consent to participate. • Not enough bone width or height for proper implant installation. • The need of bone augmentation before implant installation to obtain a prosthetically correct implantation transversally. • Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation. • Severe bruxism. Immediate insertion (e.g. placement of the implant immediately after extraction) will not be an exclusion criterion.

Design outcomes

Primary

Measure	Time frame
The main hypothesis is to test whether or not the mean marginal bone resorption for SICmax oral implants is comparable to that of SICace oral implants after an observation period of 1, 3, and 5 years. Bone resorption will be evaluated with radiographical examinations which will be performed using a standardized method direct after implantation, after the delivery of the final prosthesis, as well as 1, 3 and 5 years postoperatively.	—

Measure

Time frame

The main hypothesis is to test whether or not the mean marginal bone resorption for SICmax oral implants is comparable to that of SICace oral implants after an observation period of 1, 3, and 5 years. Bone resorption will be evaluated with radiographical examinations which will be performed using a standardized method direct after implantation, after the delivery of the final prosthesis, as well as 1, 3 and 5 years postoperatively.

—

Secondary

Measure	Time frame
The secondary objective is the evaluation of the Time-to-Failure-Event (implant loss). Here, the Event-Free-Survival is of interest.	—

Countries

Germany

Contacts

Public ContactMaria Bateli

Klinik für Zahnärztliche ProthetikZMK/Prothetik

maria.bateli@uniklinik-freiburg.de076127048470

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 25, 2026