Adjunctive Methods In Treatment Of Odontogenic Keratocyst

NCT06820229 | Completed

• 1 other identifier: Research Ethics CommiOS07-22/2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keratocysts of the Jaw

Keywords

Odontogenic keratocyst; topical 5-fluorouracil; modified carnoy's solution

Outcome Measures

Primary Outcomes (2)

• degree of pain pain

  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)

  6 month

• swelling

  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

  6 month

Secondary Outcomes (1)

• Quantitative computed tomography (CT)

  12 month

Study Arms (2)

5-FU cream Group

ACTIVE COMPARATOR

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity After enucleation and peripheral ostectomy a sterile radiopaque gauze coated with 5-fluorouracil cream 5% and put into the surgical cavity.

Procedure: Enucleation; Procedure: cyst enucleation

Modified carnoy's solution Group

ACTIVE COMPARATOR

The entire cyst lining was radically enucleated, followed by thorough curettage of the cavity A gauze was soaked in modified carnoy's solution and applied to the surgical cavity for 3 minutes Following the enucleation and peripheral ostectomy of the cyst.

Procedure: Enucleation; Procedure: cyst enucleation

Interventions

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

5-FU cream Group; Modified carnoy's solution Group

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.

5-FU cream Group; Modified carnoy's solution Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with biopsy proved odontogenic keratocyst

You may not qualify if:

• relevant systemic diseases which might affect healing process.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 3111, Egypt

Location

MeSH Terms

Conditions

Odontogenic Cysts

Interventions

Eye Enucleation

Condition Hierarchy (Ancestors)

Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mohamed K Allam, Ass prof

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: October 2, 2022
• Primary Completion: October 2, 2024
• Study Completion: January 4, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)