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

Not Applicable

Completed

• Conditions: Dental Implant Failure Nos
• Interventions: Procedure: Guided placement; Procedure: Non-guided placement; Device: Astra Tech TX implant

• Registration Number: NCT03041584
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-06
• Study Completion: 2015-06
• Study First Submitted: 2017-01-26
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FacilitateTM/ mucosa (Fac Mu)	Guided placement	-
Materialise Universal®/ mucosa (Mat Mu)	Astra Tech TX implant	-
Materialise Universal®/ bone (Mat Bo)	Astra Tech TX implant	-
FacilitateTM/ bone (Fac Bo)	Guided placement	-
mental navigation (Mental)	Non-guided placement	-
pilot-drill template (Templ)	Non-guided placement	-
Materialise Universal®/ mucosa (Mat Mu)	Guided placement	-
Materialise Universal®/ bone (Mat Bo)	Guided placement	-
FacilitateTM/ mucosa (Fac Mu)	Astra Tech TX implant	-
FacilitateTM/ bone (Fac Bo)	Astra Tech TX implant	-
mental navigation (Mental)	Astra Tech TX implant	-
pilot-drill template (Templ)	Astra Tech TX implant	-

Primary Outcome Measures

Name	Time	Method
Radiographic outcome	Change between baseline and 3 Year	Bone loss in mm

Secondary Outcome Measures

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