Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization

NCT06759610 | Completed DMC

• 1 other identifier: Tetracycline Socked Pack
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Ameloblastoma

Outcome Measures

Primary Outcomes (1)

• Radiographic assessment CBCT

  Radiographic assessment evaluate healing process CBCT (Planmeca Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative ,3 and 6 months postoperative

  From baseline to 3 and 6 months after the operation day

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Tetracyclin

Group B

ACTIVE COMPARATOR

About 7 patients who will undergo conventional marsupialization procedure

Drug: Tetracyclin

Interventions

Tetracyclin DRUG

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

Also known as: marsupialization procedure

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Location

MeSH Terms

Conditions

Ameloblastoma

Interventions

Tetracycline

Condition Hierarchy (Ancestors)

Odontogenic Tumors; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• TAREK ABDELBARY, Lecturer

  Faculty of Dentistry, Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: February 10, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 10, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-02

Locations

EG (1)