Clinical trial NCT06639230: Effect of Laser and Sclerotic Agent in the Treatment of Oral Granuloma
Official title: A Comparative Randomized Clinical Study on the Recurrence Rate of Gingival Pyogenic Granuloma Treated with Sclerotherapy Versus Diode Laser Therapy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pyogenic Granuloma of Gingiva
Keywords: pyogenic granuloma
laser therapy
sclerosing agent
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * group 1: This group was made up of ten patients treated using diode lasers with an output power of 3 W in the contact mode, the tip will be moved around the base of the lesion in circles. The base of the lesion was cut precisely till the whole mass was entirely excised.
* group 2: This group was made up of ten patients who were treated with sclerosing agent after anaesthetizing the surgical site with a local anesthetic agent, the lesion will be injected with the sclerosing agent, diluted in distilled water, the solution is injected slowly into the lesion using a 23-gauge needle until it leaks out from the surface.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain was evaluated (NRS)
timeFrame: 3 months
measure: Recurrence rate
timeFrame: 3 months
measure: Patient compliance (VAS).
timeFrame: 3 months
Secondary outcomes:
measure: Details of side effects
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
name: Ahmed Mortada Fikry, professor
role: PRINCIPAL_INVESTIGATOR
References: