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

NCT ID: NCT03041584

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Implant Failure Nos

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Materialise Universal®/ mucosa (Mat Mu)

Group Type EXPERIMENTAL

Guided placement

Intervention Type PROCEDURE

implant placement with use of guide

Astra Tech TX implant

Intervention Type DEVICE

Materialise Universal®/ bone (Mat Bo)

Group Type EXPERIMENTAL

Guided placement

Intervention Type PROCEDURE

implant placement with use of guide

Astra Tech TX implant

Intervention Type DEVICE

FacilitateTM/ mucosa (Fac Mu)

Group Type EXPERIMENTAL

Guided placement

Intervention Type PROCEDURE

implant placement with use of guide

Astra Tech TX implant

Intervention Type DEVICE

FacilitateTM/ bone (Fac Bo)

Group Type EXPERIMENTAL

Guided placement

Intervention Type PROCEDURE

implant placement with use of guide

Astra Tech TX implant

Intervention Type DEVICE

mental navigation (Mental)

Group Type ACTIVE_COMPARATOR

Non-guided placement

Intervention Type PROCEDURE

conventional implant placement

Astra Tech TX implant

Intervention Type DEVICE

pilot-drill template (Templ)

Group Type ACTIVE_COMPARATOR

Non-guided placement

Intervention Type PROCEDURE

conventional implant placement

Astra Tech TX implant

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guided placement

implant placement with use of guide

Intervention Type PROCEDURE

Non-guided placement

conventional implant placement

Intervention Type PROCEDURE

Astra Tech TX implant

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lauren Bernard

Periodontist

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B32220095376

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Accuracy of Half-guided Implant Placement
NCT04854239 COMPLETED PHASE4
Immediate Versus Late Placement
NCT04741607 RECRUITING NA