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

NCT06639230 | Not Yet Recruiting

• 1 other identifier: oral recurrent granuloma
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pyogenic Granuloma of Gingiva

Keywords

pyogenic granuloma; laser therapy; sclerosing agent

Outcome Measures

Primary Outcomes (3)

• Postoperative pain was evaluated (NRS)

  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)

  3 months

• Recurrence rate

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

  3 months

• Patient compliance (VAS).

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

  3 months

Secondary Outcomes (1)

• Details of side effects

  1 week

Study Arms (2)

Group 1: Laser-treated group

ACTIVE COMPARATOR

10 patients will be treated by laser surgery to remove oral granuloma

Device: laser therapy

Sclerotherapy-treated group (group 2)

ACTIVE COMPARATOR

This group was made up of ten patients who were treated with injections of sclerosing agent to remove pyogenic granuloma

Drug: Sclerotherapy

Interventions

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.

Group 1: Laser-treated group

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.

Sclerotherapy-treated group (group 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Percutaneous sclerotherapy for vascular malformations: a systematic review
• treatment of intraoral pyogenic granuloma with diode laser 810-980 nm.
• Oral pyogenic granuloma: Various concepts of etiopathogenesis.
• Oral Pyogenic Granuloma with Sodium Tetra Decyl Sulphate: A Case Series.

MeSH Terms

Conditions

Granuloma, Pyogenic

Interventions

Laser Therapy; Sclerotherapy

Condition Hierarchy (Ancestors)

Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Drug Therapy

Study Officials

• Ahmed Mortada Fikry, professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nashwa Helaly Mohamed, lecturer

CONTACT

+2001002226405; nashwahelaly@aun.edu.eg

AlAlzahraa Ahmed Ibrahim Alghriany, lecturer

CONTACT

+201203770058; mortadafikry@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer, Oral medicine, Periodontology and Oral diagnosis

Model Details: * 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.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share