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Copaíba Oil in the prevention and treatment of wounds in the oral cavity

Copaiba Oil in prevention and treatment of Oral Mucositis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9m57m2
Enrollment
Unknown
Registered
2020-02-11
Start date
2017-09-01
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

Neoplasia, Stomatitis

Interventions

Group 1: will consist of 30 patients under exclusive chemotherapy treatment, regardless of the type of cancer (solid or hematological) and anatomical site, which after random draw will integrate the s
mouthwash with chlorhexidine 0.12% oral solution 12 / 12h (presence of at least 1 tooth in mouth)
mouthwash with oral nystatin solution 6 / 6h - 1,000UI
removal, cleaning and storage of appliances and / or dental prostheses). Subgroup 1b - will consist of 10 patients from group 1 - oral care using the protocol used in the routine of the Service (oral
removal, cleaning and storage of appliances and / or dental prostheses) and topical application of copaiba oil 1 (once) a day, all over the oral mucosa. Subgroup 1c - will consist of 10 patients from
removal, cleaning and storage of appliances and / or dental prostheses) and to
Drug
E02.594.540
E02.190

Sponsors

Universidade de Pernambuco
Lead Sponsor
Universidade de Pernambuco
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Including individuals of both sexes, aged 18 years or older, diagnosed with solid or hematologic malignancy and under chemotherapy or radiotherapy, the latter in the head and neck region, at the Oncology Center of the Oswaldo Cruz University Hospital, to agree to conduct this study after signing the Informed Consent Form, thus allowing the use, after random draw, of one of the three methods used in this study for prevention and treatment of chemoinduced and radioinduced oral mucositis.

Exclusion criteria

Exclusion criteria: Individuals who do not meet the inclusion criteria; Individuals who meet the inclusion criteria but disagree with the study and / or individuals who initially allow the study and then express their desire to abandon the study will be excluded; Also individuals who abandon the oncological or dental treatment for oral mucositis control during the research period, or who die without being able to complete the analysis of oral condition and mucositis.

Design outcomes

Primary

MeasureTime frame
Decrease in the number of severe cases of oral mucositis, verified using the acute toxicity scale proposed by the WHO, based on the finding of a reduction in cases equivalent to grades III and IV of oral mucositis.

Secondary

MeasureTime frame
Adherence of patients, family members and medical staff regarding copaiba oil, verified through the reporting of experiences.

Countries

Brazil

Contacts

Public ContactAurora Vidal

Universidade de Pernambuco

aurorakarla@gmail.com+55-081-999775529

Outcome results

None listed

Source: REBEC (via WHO ICTRP)