Effect of Laser and Sclerotic Agent in the Treatment of Oral Granuloma

Assiut University

Status: Not yet enrolling

Conditions: Pyogenic Granuloma of Gingiva

Treatments: Device: laser therapy; Drug: Sclerotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06639230

oral recurrent granuloma

Details and patient eligibility

About

Pyogenic granuloma is a common tumor-like growth of the oral cavity considered to be non-neoplastic in nature. They usually present as a reactive lesion occur in response to chronic and recurring tissue injury, in which capillaries are very prominent commonly seen arising from interdental gingiva. Pyogenic granuloma may occur in all ages, with a peak age of incidence in the second decade of life, more common in young adult females, possibly because of vascular effects of female hormones.

Full description

Oral PG can be treated by conservative excision. Local irritants or the source of trauma must be eliminated to minimize the risk of recurrence. Although, surgical excision is considered a simple procedure, it might be complicated by several complications such as intraoperative bleeding, and postoperative infection that might delay the healing of the wound. Other treatment modalities such as laser, injection of sclerosing agents have been used.

Laser has proven to be an effective therapy for oral soft tissue pathologies. Moreover, its ability to perform precise incisions, better hemostasias, and less invasive procedures with less discomfort to patients have made it a preferred treatment option for several soft tissue lesions.

Sclerotherapy has been proposed as an effective method of treatment for pyogenic granuloma. Their mechanism of action is endothelial injury, inflammation, thrombosis, fibrosis, and final lesion destruction. Polidocanol is a widely used nonionic detergent sclerosant that was first developed as an anesthetic. It acts through endothelial overhydration, vascular injury, and closure.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All the subjects were principally diagnosed based on history and clinical features such as oral pyogenic granuloma are selected for this study. Radiographic evaluation was also done to rule out any bony involvement.
• The sizes of participants' lesions were not less than 5 mm. • Age > 18 years

Exclusion criteria

• Patients were excluded if they had uncontrolled diabetes, renal diseases, coagulation disorders or were allergic to any of the sclerosing drug constituents. Immune-compromised patients and pregnant and lactating women were also excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group 1: Laser-treated group

Active Comparator group

Description:

10 patients will be treated by laser surgery to remove oral granuloma

Treatment:

Device: laser therapy

Sclerotherapy-treated group (group 2)

Active Comparator group

Description:

This group was made up of ten patients who were treated with injections of sclerosing agent to remove pyogenic granuloma

Treatment:

Drug: Sclerotherapy