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Completed

NCT Number: NCT06054204

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

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

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Key information

Conditions

Oroantral Fistula Displaced Tooth Fistula Mouth Diseases Oral Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lateral bony window

Device

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

Primary outcomes

  1. 1. degree of pain evaluated clinically

    Time frame: one-two weeks

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

  2. soft tissue healing evaluated clinically

    Time frame: one- two week

    presence of dehiscence and exposure of bone or not

  3. the position of bony window evaluated radiographically

    Time frame: one week

    using panoramic view to evaluate the precise position of bony window

  4. bony window osteointegration and density evaluated radiographically

    Time frame: 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 outcomes

  1. inflammation clinically

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Lecturer of Oral &Maxillofacial Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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