NCT06054204

Brief Summary

Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

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

September 28, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

September 19, 2023

Last Update Submit

November 25, 2023

Conditions

Keywords

displaced rootmaxillary sinuslateral bony windowpiezoelectric device

Outcome Measures

Primary Outcomes (4)

  • 1. degree of pain evaluated clinically

    using visual analogue scale:0 represent no pain and 10 represents the highest level of pain

    one-two weeks

  • soft tissue healing evaluated clinically

    presence of dehiscence and exposure of bone or not

    one- two week

  • the position of bony window evaluated radiographically

    using panoramic view to evaluate the precise position of bony window

    one week

  • bony window osteointegration and density evaluated radiographically

    CT scan will be used using hounsfield units to evaluate density \>1250 D1 850-1250 D2 350-850 D3 150-350 D4

    four months

Secondary Outcomes (1)

  • inflammation clinically

    one week

Study Arms (1)

lateral bony window in maxillary sinus

EXPERIMENTAL

a displaced root in maxillary sinus which will be removed through a rectangular bony window will be done on the lateral wall of sinus using piezo-electric device after elevation of a full thickness mucoperiosteal flap, then the bony window will be repositioned, and the flap will be sutured.

Device: lateral bony window

Interventions

bony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane

lateral bony window in maxillary sinus

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • root displaced in maxillary sinus absence of infection

You may not qualify if:

  • patients taking medications that affect bone healing
  • patients underwent head and neck radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral FistulaMouth DiseasesStomatognathic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • mona s sheta, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR
  • marwa t Ibrahim, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single group assignment patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofacial surgery department

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

September 28, 2022

Primary Completion

July 21, 2023

Study Completion

September 30, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations