Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis
NCT ID: NCT05124366
Last Updated: 2021-11-18
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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UNKNOWN
NA
21 participants
INTERVENTIONAL
2019-09-01
2022-06-30
Brief Summary
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Study design: Double-blind, randomized controlled study.
Patients: GD patients are being selected from the Postgraduate 'Specialist in Oral Medicine' of the Faculty of Dentistry, Complutense University of Madrid.
Allocation: Patients are being randomly assigned to the study group (dental prophylaxis + oral hygiene instructions + use of propolis gel for 4 weeks) or to the placebo group (dental prophylaxis + oral hygiene instructions + use of placebo gel for 4 weeks ). Both the study gel and the placebo are being used for brushing their teeth and for application in areas with GD.
Variables: The severity of the GD will be collected according to the scale of Arduino et al. 2017 and the periodontal variables (plaque index, probing bleeding index and probing depth). Pain during treatment will be recorded using a 10 cm visual analog scale (VAS). The quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. These variables will be collected on day 0, 2 and 4 weeks after using the study gel or placebo.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Study group
Nanovitamin E, nanovitamin C and propolis extract gel
dental prophylaxis + oral hygiene instructions
Follow up: 2 weeks and 4 weeks
Placebo
Gel without nanovitamin E, nanovitamin C and propolis extract
dental prophylaxis + oral hygiene instructions
Follow up: 2 weeks and 4 weeks
Interventions
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dental prophylaxis + oral hygiene instructions
Follow up: 2 weeks and 4 weeks
Eligibility Criteria
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Inclusion Criteria
2. Patients with a clinical and histological diagnosis of some mucocutaneous disease. Patients diagnosed with oral lichen planus will be selected according to the American Academy of Oral and Maxillofacial Pathology, pemphigus vulgaris and / or scarring pemphigoid according to the 2015 World Workshop on Oral Medicine.
3. Patients who present GD, that is, erythema, epithelial desquamation, atrophy, painful erosions or ulceration of the free and / or attached gingiva, which is not related to the local accumulation of plaque.
Exclusion Criteria
2. Being diabetic.
3. Being on topical corticosteroid treatment in the previous 4 weeks or systemic treatment in the previous 8 weeks.
4. Those patients who do not present the anterosuperior sector (from canine to upper canine) or the anteroinferior sector (from canine to lower canine) will also be excluded.
5. Pregnant or breastfeeding.
6. Being a smoker.
7. Use of rinses for plaque control.
8. Being medicated with drugs associated with gingival enlargement such as cyclosporine, calcium channel blockers and phenytoin.
9. To have taken antibiotics and / or anti-inflammatories 3 months before the study.
10. Taking medications capable of producing lichenoid reactions.
11. Patients who do not want to sign the informed consent.
12. Patients with periodontitis according to the consensus criteria of Papapanou et al. 2018 or patients treated for unstable periodontal disease according to the classification of Chapple et al. 2017.
18 Years
100 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Rosa María López-Pintor Muñoz
Dos, PhD, Associate Professor.
Locations
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Universidad Complutense de Madrid
Madrid, , Spain
Countries
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Facility Contacts
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Rosa María López-Pintor, PhD
Role: primary
References
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Gonzalez-Serrano J, Serrano J, Sanz M, Torres J, Hernandez G, Lopez-Pintor RM. Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial. Clin Oral Investig. 2023 Feb;27(2):879-888. doi: 10.1007/s00784-022-04653-0. Epub 2022 Jul 28.
Other Identifiers
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0005
Identifier Type: -
Identifier Source: org_study_id