Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization

NCT ID: NCT06759610

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2024-08-10

Brief Summary

Ameloblastoma is an epithelial odontogenic tumor. Although ameloblastoma is classified as a benign tumor, it is locally invasive with high recurrence rate. It accounts for up to 18 % of all oral and odontogenic tumors.

Tetracyclines discovered in 1940s show activity against a wide variety of microorganisms including both Gram-positive and Gram-negative bacteria. Chlamydia, rickettsia, mycoplasmas, and protozoan parasites are also under its spectrum. Mechanism of action of tetracyclines is that it inhibits protein synthesis in bacteria by preventing the association of aminoacyl-tRNA with bacterial ribosome.

Detailed Description

Ameloblastoma can be described as a silent lesion, as it grows slowly and usually becomes symptomatic when it reaches a large size. Unicystic ameloblastoma (UA) accounts for about 5 % to 15 % of all ameloblastoma, with reported recurrence rates 10 % to 25%. More than 90 % of unicystic ameloblastoma involve the mandible, mostly the posterior region.

Unicystic ameloblastoma (UA) refers to those lesions that show clinical and radiographic features of an odontogenic cyst but on histological examination show an ameloblastic proliferation into the cystic lumen, confined to the cyst lining, or invade the cystic wall, hence their name are intraluminar, luminar, or mural unicystic ameloblastoma (UA), respectively.

As UA less aggressive and has low recurrence rate than conventional type, conservative approaches have been widely used for treatment of UA such as marsupialization, marsupialization followed by enucleation, or enucleation alone or with adjunctive modalities as bone curettage, or application of liquid nitrogen or carnoy's solution.

Despite progress in reconstructive surgery, extensive jaw resection influences quality of life and causes numerous complications. For this cause particularly, conservative treatment of unicystic ameloblastoma in young patients should be superior choice over other treatment methods. Marsupialization by simple definition, is the creation of a pouch surgically, by removing part of the overlying mucoperiosteoum and accompanying cyst wall; followed by suturing of the incised mucosa with the border of the remaining cyst wall that has been leaved.The reduced tension gives rise to healing and formation of bone with the surrounding bone.

Matrix metalloproteinases (MMPs) are a group of Zn-dependent enzymes which regulate inflammation. Pathologically, the elevation of MMPs causes connective tissue and bone loss in various inflammatory diseases. Tetracyclines are effective inhibitors of mammalian MMPs. Tetracyclines can inhibit both intracellular and extracellular MMPs. Tetracycline inhibits MMPs on specific sites that have been identified as the calcium and zinc-binding site at C-11 and 12.

The anti-inflammatory nature of tetracycline is utilized in the various dermatological diseases and in periodontitis too. The anti-inflammatory property of tetracyclines can be useful in the reduction of postoperative sequalae following extraction.

Conditions

Ameloblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

About 7 patients who will be subjected to marsupialization procedure with a tetracycline socked pack during marsupialization

Group Type: ACTIVE_COMPARATOR

Tetracyclin

Intervention Type: DRUG

to evaluate the effect of tetracycline socked pack on acceleration of healing during marsupialization as a primary treatment for locally invasive lesions.

Group B

About 7 patients who will undergo conventional marsupialization procedure

Group Type: ACTIVE_COMPARATOR

Tetracyclin

Intervention Type: DRUG

to evaluate the effect of tetracycline socked pack on acceleration of healing during marsupialization as a primary treatment for locally invasive lesions.

Interventions

Tetracyclin

to evaluate the effect of tetracycline socked pack on acceleration of healing during marsupialization as a primary treatment for locally invasive lesions.

Intervention Type: DRUG

Other Intervention Names

marsupialization procedure

Eligibility Criteria

Inclusion Criteria

• patients (class I category according to American society of anesthesiologists) over 20 years and under 40 years of age, of either gender who are seeking treatment of a painful intra-body mandibular swelling cystic lesions 3 x 4 cm in size with biopsy conformation that the lesion is a Uni-cystic ameloblastoma

Exclusion Criteria

• any systemic disease that interferes with bone healing,
• patients with significant medical condition,
• alcoholic individuals,
• patients on drugs that affect the central nervous systems,
• patients who reported pregnancy, lactation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Abdelbarry

Lecturer of Oral and Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TAREK ABDELBARY, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Minia University

Locations

Faculty of Dentistry, Minia University

Minya, , Egypt

Countries

Egypt

Other Identifiers

Tetracycline Socked Pack

Identifier Type: -

Identifier Source: org_study_id