Survival of 3D-planned and template-based implants inserted depending on the pre-implant hard and soft tissue management - a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005978

Enrollment

Registered

2014-07-08

Start date

2014-05-06

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: It is a single-center randomized controlled clinical trial. The evaluation is performed in a blinded. 60 patients where the removal of a tooth in the upper jaw is necessary and where a supply

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients where the removal of a tooth in the upper jaw is necessary and where a supply of a implant is planned. All patients come from the study before.

Exclusion criteria

Exclusion criteria: • Persons under 18 or not legally competent persons • Detectable primary additional for augmentation need • insertion of the implant with a Drilling template not possible (no sufficient mouth opening). • Heavy smokers (more than 10 cig. / Day) • use of bisphosphonates • Pregnant • Alcohol or drug addicts • Patients with an infectious disease such as hepatitis or HIV or AIDS • Patients with severe diabetes m.

Design outcomes

Primary

Measure	Time frame
Primary target of the analysis is the loss of the implant differentiated in an observation period of 5 years after insertion by the two groups with / without pre-implant hard and soft tissue management. In addition to target size, the accuracy of 3D implant position compared to 3D planning.	—

Secondary

Measure	Time frame
Other side targets biological and technical complications are subdivided into the two groups with / without pre-implant hard and soft tissue studied. In addition, patient satisfaction (VAS), the Pink Aesthetic score after Fürhauser et al are. 2005, the primary stability of the implant (Osstell ISQ) and the subsequent stability of the implant-served (periotest) and the efficiency of the method comparatively evaluated. Acquisition of data: baseline at the completion of prosthetic services, 1/2 year later, 1, 2, 3 and 5 years later	—

Measure

Time frame

Other side targets biological and technical complications are subdivided into the two groups with / without pre-implant hard and soft tissue studied. In addition, patient satisfaction (VAS), the Pink Aesthetic score after Fürhauser et al are. 2005, the primary stability of the implant (Osstell ISQ) and the subsequent stability of the implant-served (periotest) and the efficiency of the method comparatively evaluated. Acquisition of data: baseline at the completion of prosthetic services, 1/2 year later, 1, 2, 3 and 5 years later

—

Countries

Germany

Contacts

Public ContactSigmar Schnutenhaus

Private Praxis und Universitätsklinikum Ulm, Klinik für Zahnärztliche Prothetik

sigmar.schnutenhaus@uniklinik-ulm.de07731 182755

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026