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NCT Number: NCT05099081

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

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.

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Key information

Conditions

Pyogenic Granuloma of Gingiva Granuloma Granuloma, Pyogenic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diode laser application

Procedure

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

intra-lesional injection of ethanolamine oleate

Procedure

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.

Primary outcomes

  1. Bleeding

    Time frame: 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.

  2. Change in pain score

    Time frame: 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.

  3. Change in healing quality index

    Time frame: at 1st week, 2nd week ,4th week and 3rd month

    Will be measured according to landry classification

    • = very poor
    • = poor
    • = good
    • = very good
    • = excellent

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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