NCT05237570

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Mar 2021Feb 2027

Study Start

First participant enrolled

March 2, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

5.8 years

First QC Date

February 2, 2022

Last Update Submit

February 16, 2026

Conditions

Keywords

maxillary sinussinus liftxenograft

Outcome Measures

Primary Outcomes (1)

  • Bone height

    Bone height change

    9 months

Secondary Outcomes (1)

  • Bucco-palatal bone width

    9 months

Study Arms (2)

Control group

NO INTERVENTION

After the molar extraction, no intervention will be performed.

Interradicular septum window group

EXPERIMENTAL

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

Interventions

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.

Interradicular septum window group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Odontologico Del Sureste Slp

Murcia, 30007, Spain

RECRUITING

Related Publications (1)

  • Moreno Rodriguez JA, Pecci-Lloret M, Ortiz Ruiz E, Ortiz Ruiz AJ. Preliminary Results of a Minimally Invasive Microsurgical Approach to Sinus Floor Elevation and Bone Reconstruction Using a Palatal Septum Window. Int J Periodontics Restorative Dent. 2021 Nov-Dec;41(6):e255-e263. doi: 10.11607/prd.4810.

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosisAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBone ResorptionPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Antonio J Ortiz-Ruiz, MD

CONTACT

José A Moreno-Rodriguez, DDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and researcher

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 14, 2022

Study Start

March 2, 2021

Primary Completion (Estimated)

December 2, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations