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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Diode Laser Versus Sclerotherapy in the Treatment of Oral Pyogenic Granuloma: a Randomized-controlled Clinical Trial

Conditions
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Pyogenic Granuloma of Gingiva

Intervention / Treatment
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* Procedure: diode laser application
* Procedure: intra-lesional injection of ethanolamine oleate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders diagnosed clinically and confirmed histologically with oral pyogenic granuloma. Size of the lesion not less than 5mm. Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence. Patient age ranges from 19 to 50 years old. Exclusion Criteria: Patients with uncontrolled diabetes. Immuno-compromised patients. Patients with renal disease. Patients having coagulation disorders. Patients having allergic reaction to any of the sclerosing drug constituents. Pregnant and lactating women.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diode laser<br>diode laser application | Procedure: diode laser application<br>* Local anesthesia will be applied Lesion will be excised with diode laser (Medency, Italy) continuous wave mode 980 nm wave length with an output power 3 W in contact mode<br>|
| Active Comparator: sclerotherapy<br>intra-lesional injection of ethanolamine oleate | Procedure: intra-lesional injection of ethanolamine oleate<br>* Local anesthesia will be applied Injection of ethanolamine oleate (sclerosing gent) with concentration 5% diluted in distilled water to form 2.5% ethanolamine oleate According to lesion size range from 1.5 to 3 ml of solution will be injected slowly into lesion using gauge needle until leaked from lesion. Lesion will be compressed for 5 minutes. Lesion will be observed once a week after injection until it becomes necrotic and falls off spontaneously. Repeated injection may be needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | 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. | at baseline | 
| Change in pain score | 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. | at 2nd and 7th day | 
| Change in healing quality index | Will be measured according to landry classification = very poor = poor = good = very good = excellent | at 1st week, 2nd week ,4th week and 3rd month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pyogenic granuloma, Diode laser, Sclerotherapy, Ethanolamine oleate