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

Not Applicable

Not yet recruiting

• Conditions: Pyogenic Granuloma of Gingiva
• Interventions: Device: laser therapy; Drug: Sclerotherapy

• Registration Number: NCT06639230
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Study Start: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Laser-treated group	laser therapy	10 patients will be treated by laser surgery to remove oral granuloma
Sclerotherapy-treated group (group 2)	Sclerotherapy	This group was made up of ten patients who were treated with injections of sclerosing agent to remove pyogenic granuloma

Primary Outcome Measures

Name	Time	Method
Postoperative pain was evaluated (NRS)	3 months	Postoperative pain intensity will be perceived on the 2nd and 7th days using the ten-point Numeric Rating Scale (NRS) interpreted as 0 grade (No pain), 1-3 grade (mild pain), 4-6 grade (moderate pain) and 7-10 grade (severe pain)
Recurrence rate	3 months	Patients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.
Patient compliance (VAS).	3 months	compliance of patients will be assessed on a scale from 1 to 10

Secondary Outcome Measures

Name	Time	Method
Details of side effects	1 week	details of any side effect as bleeding, oedema, necrosis, infection after the procedure.