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

Sponsor

VNU University of Medicine and Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT06063980

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Resorption	Procedure: Conventional sinus lift surgery Procedure: Two-stage-sinus-lift procedure	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2019

Actual Primary Completion Date :

Sep 25, 2021

Actual Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Bone formation recorded after two-step-sinus-augmentation. [21 months]
9,98mm bone height is recorded on CBCT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VNU University of Medicine and Pharmacy	Hanoi		Vietnam

Sponsors and Collaborators

VNU University of Medicine and Pharmacy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pham Nhu Hai, Associate professor, VNU University of Medicine and Pharmacy

ClinicalTrials.gov Identifier:

NCT06063980

Other Study ID Numbers:

VNUMed

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Resorption

Study Results

No Results Posted as of Oct 3, 2023