Effectiveness of Diode Laser and Sclerotherapy in Treatment of Oral Pyogenic Granuloma
NCT ID: NCT05099081
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-12-04
2021-09-09
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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diode laser
diode laser application
diode laser application
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
sclerotherapy
intra-lesional injection of ethanolamine oleate
intra-lesional injection of ethanolamine oleate
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.
Interventions
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diode laser application
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
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.
Eligibility Criteria
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Inclusion Criteria
2. Size of the lesion not less than 5mm.
3. Patients included in the study will be having gingival pyogenic granuloma as it is the most common site for its occurrence.
4. Patient age ranges from 19 to 50 years old.
Exclusion Criteria
2. Immuno-compromised patients.
3. Patients with renal disease.
4. Patients having coagulation disorders.
5. Patients having allergic reaction to any of the sclerosing drug constituents.
6. Pregnant and lactating women.
19 Years
50 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Principal Investigators
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Sandra N. Edward, B.D
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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Faculty of dentistry, Alexandria University
Alexandria, , Egypt
Countries
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Other Identifiers
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IORG0008839
Identifier Type: -
Identifier Source: org_study_id