Minimally Invasive Sinus Lift Through the Interradicular Septum

November 27, 2023 updated by: Antonio José Ortiz Ruiz, MD, Universidad de Murcia

Minimally Invasive Microsurgical Sinus-lift Through the Interradicular Septum. A Clinical Trial

This study aims to describe a new approach for the reconstruction of the alveolar process in the sinus area. This minimally invasive approach will access the maxillary sinus through the alveolar process, elevating the sinus membrane in the area immediately above it. The regeneration may be achieved in the specific area required for dental implant placement, reducing the morbidity of the procedure.

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

  • Name: Antonio J Ortiz-Ruiz, MD
  • Phone Number: +34 868888581
  • Email: ajortiz@um.es

Study Contact Backup

Study Locations

  • Spain
      • Murcia, Spain, 30007
        • Recruiting
        • Centro Odontologico Del Sureste Slp
        • Contact:
          • Antonio J Ortiz-Ruiz, MD
          • Phone Number: +34 868888581
          • Email: ajortiz@um.es
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient older than 18 years.
  • Plaque index and bleeding index less than 30%.
  • Invagination of the sinus cavity in the interradicular area of the upper first molar.
  • Upper first molar not restorable and with height of the interradicular remnant less than 5 mm.

Exclusion Criteria:

  • Presence of systemic disease contraindicating the intervention.
  • Pregnant women.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
After the molar extraction, no intervention will be performed.
Experimental: Interradicular septum window group
After the extraction of the molar, the maxillary sinus membrane will be elevated through a micro-window, previously done in the interradicular septum.
Procedure: Interradicular septum window
In this group, the maxillary sinus will be accessed through a window in the interradicular septum and the membrane will be elevated, carrying out the regeneration of the area to facilitate subsequent implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone height
Time Frame: 9 months
Bone height change
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bucco-palatal bone width
Time Frame: 9 months
Bucco-palatal bone width change
9 months

Collaborators and Investigators

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

Sponsor

Universidad de Murcia

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)

March 2, 2021

Primary Completion (Estimated)

September 2, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2939/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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