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

NCT ID: NCT06639230

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-01-30

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.

Conditions

Pyogenic Granuloma of Gingiva

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Laser-treated group

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

Group Type: ACTIVE_COMPARATOR

laser therapy

Intervention Type: DEVICE

Laser-treated group (test group): This group consisted of ten patients treated using diode lasers. The diode laser was operated in continuous wave mode with an output power of 3 W in contact mode to excise the pyogenic granuloma. The tip was moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised.

Sclerotherapy-treated group (group 2)

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

Group Type: ACTIVE_COMPARATOR

Sclerotherapy

Intervention Type: DRUG

Sclerotherapy-treated group (control group): This group consisted of ten patients treated with injections of sclerosing agent. After anaesthetizing the surgical site with a local anesthetic agent, The lesion was injected with a 2.5% concentration until it leaked out from the surface, leading to necrosis and spontaneous detachment of the lesion.

Interventions

laser therapy

Laser-treated group (test group): This group consisted of ten patients treated using diode lasers. The diode laser was operated in continuous wave mode with an output power of 3 W in contact mode to excise the pyogenic granuloma. The tip was moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised.

Intervention Type: DEVICE

Sclerotherapy

Sclerotherapy-treated group (control group): This group consisted of ten patients treated with injections of sclerosing agent. After anaesthetizing the surgical site with a local anesthetic agent, The lesion was injected with a 2.5% concentration until it leaked out from the surface, leading to necrosis and spontaneous detachment of the lesion.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nashwa Helaly Mohamed

lecturer, Oral medicine, Periodontology and Oral diagnosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Mortada Fikry, professor

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nashwa Helaly Mohamed, lecturer

Role: CONTACT

nashwahelaly@aun.edu.eg

+2001002226405

AlAlzahraa Ahmed Ibrahim Alghriany, lecturer

Role: CONTACT

mortadafikry@aun.edu.eg

+201203770058

Related Links

https://pubmed.ncbi.nlm.nih.gov/24509373/

Percutaneous sclerotherapy for vascular malformations: a systematic review

https://www.jrmds.in/articles/treatment-of-pyogenic-granuloma-with-diode-laser-91896.html

treatment of intraoral pyogenic granuloma with diode laser 810-980 nm.

https://pubmed.ncbi.nlm.nih.gov/22434943/

Oral pyogenic granuloma: Various concepts of etiopathogenesis.

https://pubmed.ncbi.nlm.nih.gov/24027901/

Oral Pyogenic Granuloma with Sodium Tetra Decyl Sulphate: A Case Series.

Other Identifiers

oral recurrent granuloma

Identifier Type: -

Identifier Source: org_study_id