CClinicalTrials.gg
CompletedNCT06820229Updated Feb 12, 2025

Adjunctive Methods In Treatment Of Odontogenic Keratocyst

An interventional study of Enucleation and cyst enucleation in Keratocysts of the Jaw, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Oct 2022, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Keratocysts of the Jaw

Keywords

  • Odontogenic keratocyst
  • topical 5-fluorouracil
  • modified carnoy's solution
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • patients with biopsy proved odontogenic keratocyst

Exclusion criteria

Exclusion Criteria:

  • relevant systemic diseases which might affect healing process.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    5-FU cream Group

    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

  • Active comparator
    Modified carnoy's solution Group

    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

  • ProcedureEnucleation

    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

  • Procedurecyst enucleation

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 month

  2. 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

    Time frame: 6 month

Secondary outcomes

  1. Quantitative computed tomography (CT)

    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

    Time frame: 12 month

07

Study locations

1 site
  • Tanta University
    Tanta, Gharbia 3111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06820229
Lead sponsor
Tanta University
Responsible party
Mohamed Kamal Eid Allam (Associate professor, Tanta University) — Principal investigator
First posted
Feb 11, 2025
Start date
Oct 2, 2022
Primary completion
Oct 2, 2024
Completion
Jan 4, 2025
Last update
Feb 12, 2025

Study contacts

Mohamed K Allam, Ass prof
principal investigator · Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion