Back to resultsMinimally Invasive Sinus Lift Through the Interradicular Septum
Primary Purpose
Bone Loss, Bone Loss, Age-related, Atrophy; Alveolar Process
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Interradicular septum window
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss focused on measuring maxillary sinus, sinus lift, xenograft
Eligibility Criteria
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.
Sites / Locations
- Centro Odontologico Del Sureste SlpRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Interradicular septum window group
Arm Description
After the molar extraction, no intervention will be performed.
After the extraction of the molar, the maxillary sinus membrane will be elevated through a micro-window, previously done in the interradicular septum.
Outcomes
Primary Outcome Measures
Bone height
Bone height change
Secondary Outcome Measures
Bucco-palatal bone width
Bucco-palatal bone width change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05237570
Brief Title
Minimally Invasive Sinus Lift Through the Interradicular Septum
Official Title
Minimally Invasive Microsurgical Sinus-lift Through the Interradicular Septum. A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Bone Loss, Age-related, Atrophy; Alveolar Process, Surgical Procedure, Unspecified
Keywords
maxillary sinus, sinus lift, xenograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
After the molar extraction, no intervention will be performed.
Arm Title
Interradicular septum window group
Arm Type
Experimental
Arm Description
After the extraction of the molar, the maxillary sinus membrane will be elevated through a micro-window, previously done in the interradicular septum.
Intervention Type
Procedure
Intervention Name(s)
Interradicular septum window
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone height
Description
Bone height change
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Bucco-palatal bone width
Description
Bucco-palatal bone width change
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name or Official Title & Degree
José A Moreno-Rodriguez, DDS
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
Facility Information:
Facility Name
Centro Odontologico Del Sureste Slp
City
Murcia
ZIP/Postal Code
30007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio J Ortiz-Ruiz, MD
Phone
+34 868888581
Email
ajortiz@um.es
First Name & Middle Initial & Last Name & Degree
Jose A Moreno-Rodriguez
Phone
+34 620538483
Email
joseantonio171087@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34818393
Citation
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.
Results Reference
result
Learn more about this trial
Minimally Invasive Sinus Lift Through the Interradicular Septum
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