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Treatment effects of Anterior Open Bite and Maxillary Deficiency

Evaluation of Anterior Open Bite and Maxillary Transverse Discrepancy treatment: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3p9h7dy
Enrollment
Unknown
Registered
2023-01-14
Start date
2022-09-12
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

Open bite

Interventions

This study will be a randomized clinical trial (RCT) designed following the guidelines of the Consolidated Standards of Reporting Trials (CONSORT). The sample will consist of individuals of both gende
group 2- treated with rapid maxillary expansion
group 3- treated with rapid maxillary expansion associated with the use of spurs and group 4- treated with rapid maxillary expansion related to the use of the palatal crib. The control group will init

Sponsors

Centro Universitário Ingá - UNINGA
Lead Sponsor
Faculdade De Ensino Superior de Chapecó (FACESC)
Collaborator

Eligibility

Age
7 Years to 11 Years

Inclusion criteria

Inclusion criteria: Schoolchildren aged 7 through10 years old; systemically healthy; at the end of the first transitional period or in the intransient period of occlusion development according to the Van der Linden classification; with the maxillary first permanent molars fully erupted; patients with anterior open bite equal to or greater than 1 mm; transverse maxillary deficiency of at least 3 millimeters; etiology of anterior open bite caused by non-nutritive habits and/or atypical swallowing; prepubertal stage of vertebral maturation (cs1 or cs2 stages); agreement of parents or guardians and children to participate in the study by signing written informed consent.

Exclusion criteria

Exclusion criteria: Children with craniofacial anomalies, hyperdivergent facial pattern, congenital absence of any permanent tooth, with severe crowding, with complete deciduous or permanent dentition, with structural alterations in the anchor teeth (e.g. enamel hypoplasia, amelogenesis or dentinogenesis imperfecta), in speech therapy, children with a history of behavioral problems or uncooperative patients, children previously diagnosed as mouth breathers in treatment or who have already undergone previous orthodontic treatment.

Design outcomes

Secondary

MeasureTime frame
We do not expect secondary outcomes.

Primary

MeasureTime frame
We expect to observe greater correction of anterior open bite and increases in dental transverse distances in the experimental groups after one year of treatment. The dental changes will be evaluated using measurements obtained in the lateral cephalograms and the cast models; we expected to observe differences between the initial and final dental measurements of at least 2 mm in the control groups and 3 mm in the experimental groups. We do not expect secondary outcomes. ;Skeletal changes in the vertical and transverse measurements are expected in the experimental groups after one year of treatment. Skeletal changes will be evaluated using measurements performed on lateral cephalograms, hoping to observe differences between the initial and final skeletal measurements of at least 70% in the experimental groups. We do not expect secondary outcomes. ;In assessing oral health quality of life, we expect to observe an improvement in the experimental groups after one year of treatment. For this evaluation, the Child Perceptions Questionnaire 8-10 years old (CPQ8-10) will be applied, hoping to find an improvement in the quality of life of patients of at least 50 points in the experimental groups. We do not expect secondary outcomes. ;We expect to observe the occurrence of mild pain during activation of the expander screw, discomfort during chewing and phonation, and difficulty in performing hygiene with the use of appliances. However, we expect to observe the adaptation of patients to the devices during the treatment. These evaluations will be measured by applying visual analog scales, expecting to observe differences of around 20 to 50% between the evaluated times. We do not expect secondary outcomes.

Countries

Brazil

Contacts

Public ContactCélia Regina Vercelino

Centro Universitário Ingá - UNINGA

cepinzan@hotmail.com+55(44) 3033 5009

Outcome results

None listed

Source: REBEC (via WHO ICTRP)