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Sclerotherapy with Ethanolamine Oleate of Oral Vascular Anomalies: What is the Ideal Concentration?

Sclerotherapy with 5% Monoethanolamine Oleate Foam in Treatment of Vascular Malformations of the Head and Neck Region: A Case Series

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9xcx69
Enrollment
Unknown
Registered
2017-11-21
Start date
2014-04-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Diseases of the circulatory system, Endothelium vascular

Interventions

Control group: 10 patients sclerotherapy with monoethanolamine oleate diluted in distilled water in the ratio of 1:4 in concentration of 1.25%. Experimental group 1: 09 patients: sclerotherapy with et
Drug

Sponsors

Faculdade de Odontologia da Universidade Federal de Minas Gerais
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Minas Gerais
Collaborator

Eligibility

Age
10 Years to 86 Years

Inclusion criteria

Inclusion criteria: Patients with oral vascular anomalies less than 20 mm;diagnosis of based on the Mulliken and Glowacki (1982; indications for treatment of these lesions included pain; growth; swelling; pressure or esthetics.

Exclusion criteria

Exclusion criteria: oral vascular anomalies larger than 20mm Lesions that do not have the clinical diagnosis of vascular anamolias. Patients with a history of allergy to the drugs used.

Design outcomes

Primary

MeasureTime frame
Primary outcome: Efficacy of monoethanolamine oleate in the clinical cure of vascular anomaly, evaluated by lesion size, in mm, number of sessions and final volume of drug used.;All 3 concentrations of monoethanolamine oleate showed 100% clinical cure of the lesion, observed within a period of 12 months after the last application. Regarding the size of the lesions, there was no statistical difference between the groups, these ranged from 3-20 mm in the 5% and 2.5% concentration groups and 5-20 mm in the 1.25% group. The number of sessions of the 5% concentration group ranged from 1 to 2 sessions and was statistically different (p = 0.03 with the Kruskal-Wallis test) from the other groups (for the 1.25% group the number of sessions ranged from 1 to 4, and for the 2.5% concentration group ranged from 1 to 5 sessions). As for the final volume of monoethanolamine oleate, there was also a statistical difference (p<0.001, Kruskal-Wallis test) between the groups. In the 5% concentration group, 0.1 to 0.4 mL of monoethanolamine oleate was used, whereas for the 1.25% group it ranged from 1 to 4 mL, and for the group of 2.25% from 1 to 5 mL. Therefore, the concentration of 5% monoethanolamine oleate was more effective than the other concentrations, because it presented a smaller number of sessions (1 to 2), smaller volume (0.1 to 0.4 mL) to treat anomalies of size 3 to 20 mm.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactRicardo Mesquita

Faculdade de Odontologia da Universidade Federal de Minas Gerais

ramesquita@ufmg.br55-31-34092499

Outcome results

None listed

Source: REBEC (via WHO ICTRP)