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Clinical Trials/NCT06764654
NCT06764654
Recruiting
Not Applicable

Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement: A Multicenter Study

Aula Dental Avanzada2 sites in 1 country20 target enrollmentJanuary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Aula Dental Avanzada
Enrollment
20
Locations
2
Primary Endpoint
Three-dimensional implant position deviations (measured by intraoral scan and planning software)
Status
Recruiting
Last Updated
9 months ago

Overview

Brief Summary

This is a randomized multicenter clinical study that compares two static guided surgery techniques in free-end partial edentulism.

The aim is to compare the accuracy obtained between dento-osseous supported and dento-mucosal supported surgical splints to place dental implants in posterior osseous ridges.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
March 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aula Dental Avanzada
Responsible Party
Principal Investigator
Principal Investigator

Jose Antonio Sánchez-Nicolás

Principal Investigator

Aula Dental Avanzada

Eligibility Criteria

Inclusion Criteria

  • Patients who present to one of the two participating clinics with a posterior edentulous area starting from the second premolar.
  • Patients in whom the placement of dental implants is not contraindicated.

Exclusion Criteria

  • Patients with hypersensitivities or allergies that contraindicate the intervention.
  • Presence of orofacial neurological symptoms.
  • Patients treated with bisphosphonates.
  • Pregnant or breastfeeding women, or women undergoing contraceptive treatment.
  • Signs of infection in the surgical area.
  • Need for unconventional surgical procedures (e.g., split crest, vertical regeneration, block graft).
  • Lack of patient cooperation.

Outcomes

Primary Outcomes

Three-dimensional implant position deviations (measured by intraoral scan and planning software)

Time Frame: From enrollment to the end of surgery

Three-dimensional deviations between the planned implant position and the actual postoperative implant position will be assessed. The deviations will be measured using an intraoral scanner (Medit i700®) and planning software (BlueSky Plan®). Units of measure: horizontal and vertical linear deviation (in millimeters), global deviation (in millimeters), and angular deviation (in degrees), evaluated at both implant entry and apex points.

Secondary Outcomes

  • Three-dimensional implant position deviations (measured by CBCT and planning software)(From enrollment to the end of surgery)

Study Sites (2)

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