NCT06063980

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 2, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

September 19, 2023

Last Update Submit

October 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bone formation recorded after two-step-sinus-augmentation.

    9,98mm bone height is recorded on CBCT.

    21 months

Study Arms (2)

Conventional sinus lift procedure

OTHER

Participants assigned to conventional sinus augmentation

Procedure: Conventional sinus lift surgery

Two-stage-sinus-lift procedure

OTHER

Participants assigned to two-stage - sinus - lift procedure

Procedure: Two-stage-sinus-lift procedure

Interventions

After graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures.

Conventional 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.

Two-stage-sinus-lift procedure

Eligibility Criteria

Age40 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • mm bone height at posterior maxillae region

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VNU University of Medicine and Pharmacy

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 3, 2023

Study Start

March 2, 2019

Primary Completion

September 25, 2021

Study Completion

May 1, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Locations