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Efficacy of a Hygiene Protocol for Patients Undergoing Maxillary Disjunction with Haas Palatal Expander

Clinical Efficacy of a Professional Hygiene Protocol and its Impact on the Oral Microbiome of Patients Undergoing Maxillary Disjunction with Haas Palatal Expander: Randomized Controlled Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2d9sfvj
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-06-02
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

Oral Hygiene

Interventions

This is a randomized, controlled, blind clinical study. A total of 20 individuals who meet the eligibility criteria will be randomly selected, using a random number table, into the control or the expe
experimental group: 10 individuals with maxillary atresia who will use Haas-type expander and will be submitted to professional oral hygiene by professional cleaning of the teeth and the device, in ad
D02.078.370.141.100

Sponsors

Universidade Federal do Rio de Janeiro
Lead Sponsor
Faculdade de Odontologia da Universidade Federal do Rio de janeiro
Collaborator

Eligibility

Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: Systemically healthy patients; mixed or permanent dentition phases; erupted upper incisors and first deciduous or permanent molars; maxillary atresia; feminine and masculine genders; 8 to 18 years old

Exclusion criteria

Exclusion criteria: Presence of systemic or periodontal disease; use of antibiotics or anti-inflammatories for up to six months; use of mouthwashes or antimicrobial gels for up to one month before or during treatment; smoking; pregnancy

Design outcomes

Primary

MeasureTime frame
In order to establish a specific hygiene protocol for the period of orthodontic treatment with a Haas-type rapid palatal expander, we will analyze the changes in the oral microbiome caused by the presence of the fixed appliance and the difficulty in hygiene that it offers. Based on its resilience property, we will determine the time interval necessary for the reestablishment of the oral microbiome after treatment and removal of the appliance, as well as the influence of the application of the new proposed protocol in this time interval, by sequencing the 16s rRNA gene present in the collected samples. ;In addition, we will evaluate the relationship between the probable oral dysbiosis and the manifestation of infectious diseases of the oral cavity and halitosis in individuals with maxillary atresia admitted to the Postgraduate Clinic in Orthodontics of the School of Dentistry of the Federal University of Rio de Janeiro (UFRJ), RJ, Brazil, by identifying clinical parameters of periodontal disease, caries, integrity of the palatal mucosa and halitosis at different times, before and during treatment.

Secondary

MeasureTime frame
No secondary effects are expected.

Countries

Brazil

Contacts

Public ContactAmanda de Freitas

Faculdade de Odontologia da Universidade Federal do Rio de janeiro

amandaoaf@gmail.com+55 (21) 99531-7750

Outcome results

None listed

Source: REBEC (via WHO ICTRP)