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Gel for orthodontic aligners

Chitosan gel and Melaleuca essential oil for orthodontic aligners - a randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7yqtbvk
Enrollment
Unknown
Registered
2023-12-27
Start date
2025-03-03
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

Gingivitis

Interventions

This is a randomized controlled clinical study. Participants will be randomized by chance and randomly allocated to 3 groups: 1 - 40 patients who will use the control gel (CG)
2 - 40 patients who will use the chitosan gel (CG)
3 - 40 patients who will use the chitosan gel + melaleuca essential oil (COG). Participants must follow the following protocol: wear the aligners for 6 months, 24 hours a day, except for eating and cl
put the gel on the two aligners (upper and lower) before going to bed, so that it covers the buccal and palatal surfaces of all the teeth
in the morning, clean the aligners and wear them without the gel.

Sponsors

Universidade Federal de Juiz de Fora
Lead Sponsor
Universidade Federal de Juiz de Fora
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: Participants will be included in the study: both sexes; aged between 18 and 30 years; absence of systemic disease known by the individual to affect periodontal tissues (such as cardiovascular diseases, diseases leading to neutropenia, diabetes, leukemia and AIDS); absence of periodontal disease prior to orthodontic therapy; absence of extensive restorations.

Exclusion criteria

Exclusion criteria: Participants who do not correctly follow the protocol for using gel in orthodontic aligners will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
It is expected to find a positive impact of the antimicrobial action of chitosan gel and tea tree essential oil on periodontal tissues during the use of orthodontic aligners

Secondary

MeasureTime frame
Using the periodontal indices (plaque indice - Silness and Löe, 1964; gingival bleeding indice on probing - Löe, 1967), we will analyse whether there has been a reduction in their values between the different times analyse, and thus analyse whether there was an improvement in periodontal health

Countries

Brazil

Contacts

Public ContactFernanda Faria

Universidade Federal de Juiz de Fora

fernandaramosfaria@gmail.com+5532984294949

Outcome results

None listed

Source: REBEC (via WHO ICTRP)