Clinical trial NCT05099081: Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma
Official title: Effectiveness of Diode Laser Versus Sclerotherapy in the Treatment of Oral Pyogenic Granuloma: a Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pyogenic Granuloma of Gingiva
Keywords: Pyogenic granuloma
Diode laser
Sclerotherapy
Ethanolamine oleate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bleeding
timeFrame: at baseline
measure: Change in pain score
timeFrame: at 2nd and 7th day
measure: Change in healing quality index
timeFrame: at 1st week, 2nd week ,4th week and 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Sandra N. Edward, B.D
role: PRINCIPAL_INVESTIGATOR
References: