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Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.

Primary Purpose

Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Conventional sinus lift surgery
Two-stage-sinus-lift procedure
Sponsored by
VNU University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption

Eligibility Criteria

40 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 0mm bone height at posterior maxillae region Exclusion Criteria: general contraindication to implant surgery subjected to irradiation in the head and neck area <1 one year before implantation uncontrolled diabetes pregnant or nursing substance abuse heavy smoker psychiatric therapy or unrealistic expectations immunosuppressed or immunocompromised treated or under treatment with oral or intravenous aminobisphosphonates untreated periodontitis poor oral hygiene and motivation

Sites / Locations

  • VNU University of Medicine and Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Conventional sinus lift procedure

Two-stage-sinus-lift procedure

Arm Description

Participants assigned to conventional sinus augmentation

Participants assigned to two-stage - sinus - lift procedure

Outcomes

Primary Outcome Measures

Bone formation recorded after two-step-sinus-augmentation.
9,98mm bone height is recorded on CBCT.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2023
Last Updated
October 2, 2023
Sponsor
VNU University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT06063980
Brief Title
Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.
Official Title
Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2019 (Actual)
Primary Completion Date
September 25, 2021 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VNU University of Medicine and Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. This case study aims to compare two cases of 0mm bone height in the posterior maxillae region with different handling procedure. In this article, two female patients in their 40s underwent maxillary sinus augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through conventional sinus augmentation while the other had a two-stage - sinus - lift procedure. Researchers compared the bone - volume induced between the two procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional sinus lift procedure
Arm Type
Other
Arm Description
Participants assigned to conventional sinus augmentation
Arm Title
Two-stage-sinus-lift procedure
Arm Type
Other
Arm Description
Participants assigned to two-stage - sinus - lift procedure
Intervention Type
Procedure
Intervention Name(s)
Conventional sinus lift surgery
Intervention Description
After graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures.
Intervention Type
Procedure
Intervention Name(s)
Two-stage-sinus-lift procedure
Intervention Description
Procedure is performed in two stages with the purpose of stage one to separate the oral mucosa from the sinus membrane using a small amount of bone graft and stage two as actual sinus augmentation, which is performed similar to that of conventional sinus lift procedure.
Primary Outcome Measure Information:
Title
Bone formation recorded after two-step-sinus-augmentation.
Description
9,98mm bone height is recorded on CBCT.
Time Frame
21 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 0mm bone height at posterior maxillae region Exclusion Criteria: general contraindication to implant surgery subjected to irradiation in the head and neck area <1 one year before implantation uncontrolled diabetes pregnant or nursing substance abuse heavy smoker psychiatric therapy or unrealistic expectations immunosuppressed or immunocompromised treated or under treatment with oral or intravenous aminobisphosphonates untreated periodontitis poor oral hygiene and motivation
Facility Information:
Facility Name
VNU University of Medicine and Pharmacy
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.

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