Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma

Not Applicable

Completed

• Conditions: Pyogenic Granuloma of Gingiva
• Interventions: Procedure: diode laser application; Procedure: intra-lesional injection of ethanolamine oleate

• Registration Number: NCT05099081
• Lead Sponsor: Alexandria University

Brief Summary

To clinically assess the effectiveness of diode laser versus sclerotherapy in the treatment of oral pyogenic granuloma.

A randomized-controlled clinical trial conducted on 20 patients with oral pyogenic granuloma. Patients were assigned into two groups. Group I treated by diode laser1; group II treated by injection of ethanolamine oleate2 as sclerosing agent. All patients were clinically assessed for pain, bleeding during surgery and healing quality; 1st week, 2nd week and 4th week. The patients were followed up after 3 months from the end of treatment.

Detailed Description

Background: Pyogenic granuloma (PG) is one of the most common reactive hyperplasia that causes soft tissue enlargement. It affects skin and oral mucosa. The traditional treatment for oral PG is conservative surgical excision with cold blade together with the removal of causative irritant or source of trauma. Bleeding susceptibility, healing quality and pain represent common complications following surgical excision of pyogenic granuloma. Sclerosing agents are widely used in the treatment of pyogenic granuloma as it is a conservative non painful procedure. The use of lasers in dentistry have grown in the last 4 decades. It has proved its efficacy in the treatment of pyogenic granuloma.

Study objective: Study will be conducted to evaluate healing quality of using diode laser versus sclerotherapy (Ethanolamine oleate) in the treatment of oral pyogenic granuloma.

Materials and Method: This randomized controlled clinical trial will include 20 patients with pyogenic granuloma, divided equally into two groups. Group-I (test group) will be managed by application of diode laser. Group- II (control group) will be managed by injection of ethanolamine oleate as sclerosing agent on weekly injection visits. Patients of both groups will be evaluated intraoperatively for bleeding severity and postoperatively in terms of pain at the 2nd and 7th day and healing quality.

Results: Results will be tabulated and statistically analysed.

Study Timeline

• Study Start: 2020-12-04
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-09
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma.
2. Size of the lesion not less than 5mm.
3. Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
4. Patient age ranges from 19 to 50 years old.

Exclusion Criteria

1. Patients with uncontrolled diabetes.
2. Immuno-compromised patients.
3. Patients with renal disease.
4. Patients having coagulation disorders.
5. Patients having allergic reaction to any of the sclerosing drug constituents.
6. Pregnant and lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diode laser	diode laser application	diode laser application
sclerotherapy	intra-lesional injection of ethanolamine oleate	intra-lesional injection of ethanolamine oleate

Primary Outcome Measures

Name	Time	Method
Change in pain score	at 2nd and 7th day	Postoperative pain will be evaluated at 2nd and 7th day using numeric rating scale (NRS) 0 = no pain. 1-3 = mild pain. 4-6 = moderate pain. 7-10 = severe pain.
Change in healing quality index	at 1st week, 2nd week ,4th week and 3rd month	Will be measured according to landry classification; 1. = very poor; 2. = poor; 3. = good; 4. = very good; 5. = excellent
Bleeding	at baseline	Mild: Subsides at 20 min after applying pressure with gauze. Moderate: Requires haemostatic irrigation. Severe: Needs suturing and might need vitamin K administration or fresh frozen plasma infusion.

Trial Locations

Locations (1)

Faculty of dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt