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Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization

Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization as a Primary Treatment for Locally Invasive Lesion: Single Blinded Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06759610
Enrollment
14
Registered
2025-01-06
Start date
2024-02-10
Completion date
2024-08-10
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ameloblastoma

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.

Interventions

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic assessment CBCTFrom baseline to 3 and 6 months after the operation dayRadiographic assessment evaluate healing process CBCT (Planmeca Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative ,3 and 6 months postoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026