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

February 1, 2017 updated by: Lauren Bernard, KU Leuven

Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Materialise Universal®/ mucosa (Mat Mu)
Procedure: Guided placement
implant placement with use of guide
Device: Astra Tech TX implant
EXPERIMENTAL: Materialise Universal®/ bone (Mat Bo)
Procedure: Guided placement
implant placement with use of guide
Device: Astra Tech TX implant
EXPERIMENTAL: FacilitateTM/ mucosa (Fac Mu)
Procedure: Guided placement
implant placement with use of guide
Device: Astra Tech TX implant
EXPERIMENTAL: FacilitateTM/ bone (Fac Bo)
Procedure: Guided placement
implant placement with use of guide
Device: Astra Tech TX implant
ACTIVE_COMPARATOR: mental navigation (Mental)
Device: Astra Tech TX implant
Procedure: Non-guided placement
conventional implant placement
ACTIVE_COMPARATOR: pilot-drill template (Templ)
Device: Astra Tech TX implant
Procedure: Non-guided placement
conventional implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic outcome
Time Frame: Change between baseline and 3 Year
Bone loss in mm
Change between baseline and 3 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing pocket depth
Time Frame: Change between baseline and 3 Year
measurement in mm of pocket around implant, 4 per implant
Change between baseline and 3 Year
bleeding on probing
Time Frame: Change between baseline and 3 Year
measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant
Change between baseline and 3 Year
plaque
Time Frame: Change between baseline and 3 Year
measurement of presence of plaque, Yes =1, No=0. 4 per implant
Change between baseline and 3 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Dentsply Sirona Implants and Consumables

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (ESTIMATE)

February 3, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • B32220095376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Implant Failure Nos

Clinical Trials on Guided placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe