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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Implant Failure Nos

Intervention / Treatment
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* Procedure: Guided placement
* Procedure: Non-guided placement
* Device: Astra Tech TX implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent An age of at least 18 year Extraction socket healing for at least 6 months Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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