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

July 3, 2025 updated by: Jose Antonio Sánchez-Nicolás, Aula Dental Avanzada

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Alicante, Spain, 03001
        • Recruiting
        • Clínica Dental Esteve
        • Contact:
        • Sub-Investigator:
          • Guillem Esteve-Pardo, PhD
    • Murcia
      • Cabezo De Torres, Murcia, Spain, 30110
        • Recruiting
        • Clínica Dental Sánchez Nicolás
        • Contact:
        • Principal Investigator:
          • Jose Antonio Sánchez-Nicolás, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tooth supported guide
Patients who will receive implant placement using a tooth supported surgical guide.
Procedure: Dental implant placement
Placement of two dental implants in the jaw.
Experimental: Bone and tooth supported guide
Patients who will receive implant placement using a bone and tooth supported surgical guide.
Procedure: Dental implant placement
Placement of two dental implants in the jaw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three-dimensional implant position deviations (measured by CBCT 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 cone-beam computed tomography (CBCT) 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.
From enrollment to the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aula Dental Avanzada

Collaborators

Mozo Grau Ticare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 8, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUIDED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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