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

A Comparative Randomized Clinical Study on the Recurrence Rate of Gingival Pyogenic Granuloma Treated with Sclerotherapy Versus Diode Laser Therapy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pyogenic Granuloma of Gingiva
• Intervention / Treatment: Device: laser therapy; Drug: Sclerotherapy

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nashwa Helaly Mohamed, lecturer; Phone Number: +2001002226405; Email: nashwahelaly@aun.edu.eg
• Study Contact Backup: Name: AlAlzahraa Ahmed Ibrahim Alghriany, lecturer; Phone Number: +201203770058; Email: mortadafikry@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Laser-treated group; 10 patients will be treated by laser surgery to remove oral granuloma	Device: 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.
Active Comparator: 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	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain was evaluated (NRS)	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)	3 months
Recurrence rate	Patients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.	3 months
Patient compliance (VAS).	compliance of patients will be assessed on a scale from 1 to 10	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Details of side effects	details of any side effect as bleeding, oedema, necrosis, infection after the procedure.	1 week

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Mortada Fikry, professor

Publications and helpful links

Helpful Links

• Percutaneous sclerotherapy for vascular malformations: a systematic review
• treatment of intraoral pyogenic granuloma with diode laser 810-980 nm.
• Oral pyogenic granuloma: Various concepts of etiopathogenesis.
• Oral Pyogenic Granuloma with Sodium Tetra Decyl Sulphate: A Case Series.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: laser therapy; pyogenic granuloma; sclerosing agent
• Additional Relevant MeSH Terms: Pathologic Processes; Lymphoproliferative Disorders; Lymphatic Diseases; Granuloma; Granuloma, Pyogenic
• Other Study ID Numbers: oral recurrent granuloma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No