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Completed

NCT Number: NCT05329974

Computer Guided Buccal Cortical Plate Separation for Removal of Calcified Benign Odontogenic Tumors Affecting Mandibular Angle Region

Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

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Key information

Conditions

Odontogenic Tumors Neoplasms Neoplasms by Histologic Type Odontoma

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo, Egypt

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About this study

Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique

Exclusion criteria

  • Patients with any medical condition contraindicating the surgical procedures were excluded

Treatment and study plan

Computer guided buccal cortical plate separation

Other

Computer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors

Primary outcomes

  1. Intra-operative time

    Time frame: during the surgery

    Intra-operative time was measured from the start of the incision till suturing

Secondary outcomes

  1. Postoperative pain

    Time frame: 2, 5, and 10 days after the surgery

    Postoperative pain using 0 - 10 visual analog scale

  2. Edema

    Time frame: 5 and 10 days after the surgery

    Edema was assessed using a four grades scale: Grade 0, No edema; Grade 1, mild edema (just visible); Grade 2; moderate edema (local); Grade 3, severe edema (extended).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2022
Registry last updated
Apr 15, 2022

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

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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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