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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Resorption
• Intervention / Treatment: Procedure: Conventional sinus lift surgery; Procedure: Two-stage-sinus-lift procedure

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • VNU University of Medicine and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional sinus lift procedure; Participants assigned to conventional sinus augmentation	Procedure: Conventional sinus lift surgery; After graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures.
Other: Two-stage-sinus-lift procedure; Participants assigned to two-stage - sinus - lift procedure	Procedure: Two-stage-sinus-lift procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone formation recorded after two-step-sinus-augmentation.	9,98mm bone height is recorded on CBCT.	21 months

Collaborators and Investigators

• Sponsor: VNU University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2019
• Primary Completion (Actual): September 25, 2021
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: VNUMed

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No