NCT05872321

Brief Summary

For patients requiring LSFE, demographic data, including age, sex and smoking habits were collected. Preoperative CBCT images were analyzed for radiographic assessment of risk factors through measurement of sinus mucosa thickness, sinus lateral wall thickness, sinus width, presence of Underwood's septa, and presence of the alveolar antral artery. A bone consuming technique using piezosurgery was implemented. This technique involved eroding the buccal bone prior to window outlining followed mucosal elevation using novel ultrasonic curettes. sinus mucosa perforation, hemorrhage, and postoperative infectious complications were documented. The measurement of the studied factors was performed on Newtom VGI viewer software, by two evaluators J.B. and A.M.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

February 12, 2026

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

May 14, 2023

Last Update Submit

February 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perioperative complication

    We will monitor the prevalence of membrane perforation during external sinus lift procedure

    During surgical procedure

Study Arms (1)

Per-operative Complication

Other: Complication

Interventions

whether or not complications occur

Per-operative Complication

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patient needing lateral sinus lift procedure prior to implant placement.

You may qualify if:

  • Patients who received lateral sinus floor elevation using this new piezosurgery technique.

You may not qualify if:

  • the usual exclsion criteria for external sinus lift procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph University

Beirut, Lebanon

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2023

First Posted

May 24, 2023

Study Start

July 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

February 12, 2026

Record last verified: 2023-06

Locations