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NCT Number: NCT06820229

Adjunctive Methods In Treatment Of Odontogenic Keratocyst

The purpose of this study was to compare both clinically and radiographically the effect of using 5- fluorouracil cream (5-FU) versus modified carnoy's solution (MCS) as adjunctive methods in treatment of odontogenic keratocyst (OKC).

Patients and methods :This is an interventional, comparative study that was carried on 20 patients with mandibular odontogenic keratocyst and were divided randomly into two equal groups, Group I: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of 5-FU cream. Group II: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of MCS. All patients were followed up for 9 months postoperatively.

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Key information

Conditions

Keratocysts of the Jaw Bone Cysts Cysts Jaw Cysts Jaw Diseases Musculoskeletal Diseases Neoplasms Odontogenic Cysts Stomatognathic Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 3111, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with biopsy proved odontogenic keratocyst

Exclusion criteria

  • relevant systemic diseases which might affect healing process.

Treatment and study plan

enucleation

Procedure

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity with meticulous evaluation of any residual daughter cyst lining followed by reduction of lingual and buccal walls bony undercuts to remove any residual cystic epithelium

cyst enucleation

Procedure

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity with meticulous evaluation of any residual daughter cyst lining followed by reduction of lingual and buccal walls bony undercuts to remove any residual cystic epithelium.

Using coarse round surgical carbide burs under copious normal saline irrigation, peripheral ostectomy was done for all bony walls to remove any microscopic daughter cyst, with isolation, retraction, and preservation of the lingual and inferior alveolar bundle. The bony septa were removed using rotary Lindemann fissure burs in case of multilocular lesions.

After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.

Primary outcomes

  1. degree of pain pain

    Time frame: 6 month

    degree of pain pain is measured on a visual analogue scale (VAS) started from 0 which represent (no pain at all) and end by 10 which represent (most severe pain)

  2. swelling

    Time frame: 6 month

    Swelling is assessed using a vertical and horizontal references with a tape on four reference points; outer canthus of the eye, angle of the mandible, tragus, and outer corner of the mouth

Secondary outcomes

  1. Quantitative computed tomography (CT)

    Time frame: 12 month

    Quantitative interpretation of values derived from Hounsfield units with a suitable calibration procedure is the modality of choice to determine the local bone mineral density during the follow up periods

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

5-Fluorouracil Cream Versus Modified Carnoy's Solution As Adjunctive Methods In Treatment Of Odontogenic Keratocyst

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 12, 2025

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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