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

KU Leuven60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implant Failure Nos

Interventions

Guided placementPROCEDURE

implant placement with use of guide

Non-guided placementPROCEDURE

conventional implant placement

Astra Tech TX implantDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Radiographic outcome

Bone loss in mm

Time frame: Change between baseline and 3 Year

Secondary Outcomes

probing pocket depth

measurement in mm of pocket around implant, 4 per implant

Time frame: Change between baseline and 3 Year

bleeding on probing

measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant

Time frame: Change between baseline and 3 Year

plaque

measurement of presence of plaque, Yes =1, No=0. 4 per implant

Time frame: Change between baseline and 3 Year

Data from ClinicalTrials.gov

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