Minimally Invasive Sinus Lift Through the Interradicular Septum

• Sponsor: Universidad de Murcia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05237570
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Loss; Bone Loss, Age-related; Atrophy; Alveolar Process; Surgical Procedure, Unspecified	Procedure: Interradicular septum window	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Minimally Invasive Microsurgical Sinus-lift Through the Interradicular Septum. A Clinical Trial
• Actual Study Start Date: Mar 2, 2021
• Anticipated Primary Completion Date: Feb 2, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Bone height [9 months]

   Bone height change

Secondary Outcome Measures

1. Bucco-palatal bone width [9 months]

   Bucco-palatal bone width change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Odontologico Del Sureste Slp	Murcia		Spain	30007

Sponsors and Collaborators

• Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio José Ortiz Ruiz, MD, Professor and researcher, Universidad de Murcia
• ClinicalTrials.gov Identifier: NCT05237570
• Other Study ID Numbers: 2939/2020
• First Posted: Feb 14, 2022
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio José Ortiz Ruiz, MD, Professor and researcher, Universidad de Murcia: maxillary sinus; sinus lift; xenograft
• Additional relevant MeSH terms: Osteoporosis; Alveolar Bone Loss

Study Results

No Results Posted as of May 19, 2022