Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study

Catholic University (KU) of Leuven

Status: Completed

Conditions: Dental Implant Failure Nos

Treatments: Procedure: Non-guided placement; Device: Astra Tech TX implant; Procedure: Guided placement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03041584

B32220095376

Details and patient eligibility

About

To assess implant outcomes, both clinical and radiological, in a randomized study on guided implant placement after 3-year follow-up, compared to non-guided treatment.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of informed consent
2. An age of at least 18 year
3. Extraction socket healing for at least 6 months

Exclusion criteria

1. Unlikely to be able to comply with study procedures
2. History of intravenous bisphosphonate treatment
3. Medical history that makes implant insertion unfavorable
4. Current pregnancy
5. Present alcohol and/or drug abuse
6. Major systemic diseases
7. Untreated, uncontrolled caries and/or periodontal disease
8. History of local irradiation
9. Need for bone grafting and/or sinus lift in the planned implant area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 6 patient groups

Materialise Universal®/ mucosa (Mat Mu)

Experimental group

Treatment:

Device: Astra Tech TX implant

Procedure: Guided placement

Materialise Universal®/ bone (Mat Bo)

Experimental group

Treatment:

Device: Astra Tech TX implant

Procedure: Guided placement

FacilitateTM/ mucosa (Fac Mu)

Experimental group

Treatment:

Device: Astra Tech TX implant

Procedure: Guided placement

FacilitateTM/ bone (Fac Bo)

Experimental group

Treatment:

Device: Astra Tech TX implant

Procedure: Guided placement

mental navigation (Mental)

Active Comparator group

Treatment:

Procedure: Non-guided placement

Device: Astra Tech TX implant

pilot-drill template (Templ)

Active Comparator group

Treatment:

Procedure: Non-guided placement

Device: Astra Tech TX implant