Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device

Not Applicable

Completed

• Conditions: Displaced Tooth; Oroantral Fistula
• Interventions: Device: lateral bony window

• Registration Number: NCT06054204
• Lead Sponsor: Tanta University

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

Detailed Description

Purpose: This study is designed to allow removal of displaced root from maxillary sinus with minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of maxillary sinus by repositioning of osteotomized lateral bony window.

Materials \& Methods: Ten patients with displaced root in maxillary sinus will be included in this study.

surgical procedure: A full thickness flap will be elevated to expose the lateral wall of the sinus and a rectangular bony window will be done, then the sinus lining will be incised, the displaced root will be delivered, the bony window will be repositioned, and the flap will be sutured.

Preoperative evaluation: The patients will be evaluated clinically for presence of inflammation, infection or oroantral communication and radiographically using computed tomography (CT) scan to identify the position of the displaced root.

Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation. Radiographically, immediate panoramic view to evaluate the position of bony window and four months later to evaluate bone healing CT scan.

Study Timeline

• Study Start: 2022-09-28
• Primary Completion: 2023-07-21
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-25
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

root displaced in maxillary sinus absence of infection

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lateral bony window in maxillary sinus	lateral bony window	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.

Primary Outcome Measures

Name	Time	Method
1. degree of pain evaluated clinically	one-two weeks	using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing evaluated clinically	one- two week	presence of dehiscence and exposure of bone or not
the position of bony window evaluated radiographically	one week	using panoramic view to evaluate the precise position of bony window
bony window osteointegration and density evaluated radiographically	four months	CT scan will be used using hounsfield units to evaluate density \>1250 D1 850-1250 D2 350-850 D3 150-350 D4

Secondary Outcome Measures

Name	Time	Method
inflammation clinically	one week	0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Egypt