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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06639230
Enrollment
20
Registered
2024-10-15
Start date
2024-10-15
Completion date
2025-01-30
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyogenic Granuloma of Gingiva

Keywords

pyogenic granuloma, laser therapy, sclerosing agent

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.

Interventions

DEVICElaser therapy

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-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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain was evaluated (NRS)3 monthsPostoperative 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)
Recurrence rate3 monthsPatients will be recalled monthly for 3 months after the end of treatment to evaluate if recurrent occur or not.
Patient compliance (VAS).3 monthscompliance of patients will be assessed on a scale from 1 to 10

Secondary

MeasureTime frameDescription
Details of side effects1 weekdetails of any side effect as bleeding, oedema, necrosis, infection after the procedure.

Contacts

Primary ContactNashwa Helaly Mohamed, lecturer
nashwahelaly@aun.edu.eg+2001002226405
Backup ContactAlAlzahraa Ahmed Ibrahim Alghriany, lecturer
mortadafikry@aun.edu.eg+201203770058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026