Dental Implants Placed by Using a Drill Guide Versus Non-guided Placement. Follow-up Study
Implant-centered Outcomes of Guided Surgery, a 3-year Follow-up: An RCT Comparing Guided Surgery With Non-guided Implant Placement
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
February 3, 2017
CompletedFebruary 3, 2017
February 1, 2017
3.4 years
January 26, 2017
February 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic outcome
Bone loss in mm
Change between baseline and 3 Year
Secondary Outcomes (3)
probing pocket depth
Change between baseline and 3 Year
bleeding on probing
Change between baseline and 3 Year
plaque
Change between baseline and 3 Year
Study Arms (6)
Materialise Universal®/ mucosa (Mat Mu)
EXPERIMENTALMaterialise Universal®/ bone (Mat Bo)
EXPERIMENTALFacilitateTM/ mucosa (Fac Mu)
EXPERIMENTALFacilitateTM/ bone (Fac Bo)
EXPERIMENTALmental navigation (Mental)
ACTIVE COMPARATORpilot-drill template (Templ)
ACTIVE COMPARATORInterventions
implant placement with use of guide
conventional implant placement
Eligibility Criteria
You may qualify if:
- Provision of informed consent
- An age of at least 18 year
- Extraction socket healing for at least 6 months
You may not qualify if:
- Unlikely to be able to comply with study procedures
- History of intravenous bisphosphonate treatment
- Medical history that makes implant insertion unfavorable
- Current pregnancy
- Present alcohol and/or drug abuse
- Major systemic diseases
- Untreated, uncontrolled caries and/or periodontal disease
- History of local irradiation
- Need for bone grafting and/or sinus lift in the planned implant area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- Dentsply Sirona Implants and Consumablescollaborator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Periodontist
Study Record Dates
First Submitted
January 26, 2017
First Posted
February 3, 2017
Study Start
January 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2015
Last Updated
February 3, 2017
Record last verified: 2017-02