Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma
Condition: Pyogenic Granuloma of Gingiva
MeSH terms: Granuloma; Granuloma, Pyogenic
Study type: Interventional

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.
    

Intervention name(s): diode laser application; intra-lesional injection of ethanolamine oleate
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; 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.
Intervention MeSH terms: Ethanolamine oleate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pyogenic granuloma; Diode laser; Sclerotherapy; Ethanolamine oleate