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NCT Number: NCT06639230

Effect of Laser and Sclerotic Agent in the Treatment of Oral Granuloma

Pyogenic granuloma is a common tumor-like growth of the oral cavity considered to be non-neoplastic in nature. They usually present as a reactive lesion occur in response to chronic and recurring tissue injury, in which capillaries are very prominent commonly seen arising from interdental gingiva. Pyogenic granuloma may occur in all ages, with a peak age of incidence in the second decade of life, more common in young adult females, possibly because of vascular effects of female hormones.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Oral PG can be treated by conservative excision. Local irritants or the source of trauma must be eliminated to minimize the risk of recurrence. Although, surgical excision is considered a simple procedure, it might be complicated by several complications such as intraoperative bleeding, and postoperative infection that might delay the healing of the wound. Other treatment modalities such as laser, injection of sclerosing agents have been used.

Laser has proven to be an effective therapy for oral soft tissue pathologies. Moreover, its ability to perform precise incisions, better hemostasias, and less invasive procedures with less discomfort to patients have made it a preferred treatment option for several soft tissue lesions.

Sclerotherapy has been proposed as an effective method of treatment for pyogenic granuloma. Their mechanism of action is endothelial injury, inflammation, thrombosis, fibrosis, and final lesion destruction. Polidocanol is a widely used nonionic detergent sclerosant that was first developed as an anesthetic. It acts through endothelial overhydration, vascular injury, and closure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All the subjects were principally diagnosed based on history and clinical features such as oral pyogenic granuloma are selected for this study. Radiographic evaluation was also done to rule out any bony involvement.
  • The sizes of participants' lesions were not less than 5 mm. • Age > 18 years

Exclusion criteria

  • Patients were excluded if they had uncontrolled diabetes, renal diseases, coagulation disorders or were allergic to any of the sclerosing drug constituents. Immune-compromised patients and pregnant and lactating women were also excluded from the study.

Treatment and study plan

Laser Therapy

Device

Laser-treated group (test group): This group consisted of ten patients treated using diode lasers. The diode laser was operated in continuous wave mode with an output power of 3 W in contact mode to excise the pyogenic granuloma. The tip was moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised.

Sclerotherapy

Drug

Sclerotherapy-treated group (control group): This group consisted of ten patients treated with injections of sclerosing agent. After anaesthetizing the surgical site with a local anesthetic agent, The lesion was injected with a 2.5% concentration until it leaked out from the surface, leading to necrosis and spontaneous detachment of the lesion.

Primary outcomes

  1. Postoperative pain was evaluated (NRS)

    Time frame: 3 months

    Postoperative pain intensity will be perceived on the 2nd and 7th days using the ten-point Numeric Rating Scale (NRS) interpreted as 0 grade (No pain), 1-3 grade (mild pain), 4-6 grade (moderate pain) and 7-10 grade (severe pain)

  2. Recurrence rate

    Time frame: 3 months

    Patients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.

  3. Patient compliance (VAS).

    Time frame: 3 months

    compliance of patients will be assessed on a scale from 1 to 10

Secondary outcomes

  1. Details of side effects

    Time frame: 1 week

    details of any side effect as bleeding, oedema, necrosis, infection after the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

AlAlzahraa Ahmed Ibrahim Alghriany, lecturer

CONTACT

[email protected]

+201203770058

Nashwa Helaly Mohamed, lecturer

CONTACT

[email protected]

+2001002226405

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

A Comparative Randomized Clinical Study on the Recurrence Rate of Gingival Pyogenic Granuloma Treated with Sclerotherapy Versus Diode Laser Therapy.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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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