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

Dental Implant Failure Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041584
• Other study ID #: B32220095376
• Status: Completed
• Phase: N/A
• First received: January 26, 2017
• Last updated: February 1, 2017
• Start date: January 2009
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant Failure Nos

Intervention

Procedure:
• Guided placement
implant placement with use of guide
• Non-guided placement
conventional implant placement

Device:
• Astra Tech TX implant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Dentsply Sirona Implants

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic outcome	Bone loss in mm	Change between baseline and 3 Year
Secondary	probing pocket depth	measurement in mm of pocket around implant, 4 per implant	Change between baseline and 3 Year
Secondary	bleeding on probing	measurement of presence of bleeding on probing, Yes =1, No=0. 4 per implant	Change between baseline and 3 Year
Secondary	plaque	measurement of presence of plaque, Yes =1, No=0. 4 per implant	Change between baseline and 3 Year