American Journal of Orthodontics and Dentofacial Orthopedics
Randomized controlled trialDental arch changes after open bite treatment with spurs associated with posterior build-ups in the mixed dentition: A randomized clinical trial
Section snippets
Specific objectives or hypotheses
This RCT aimed to compare the dimensional changes on maxillary and mandibular dental arches after AOB treatment with bonded spurs associated with posterior build-ups (SBU) and bonded spurs alone (S). The null hypothesis tested was that both therapies have similar dental arch outcomes.
Trial design and any changes after trial commencement
This study was conducted as a 2-arm parallel, single-center RCT with a 1:1 allocation ratio, following the Consolidated Standards of Reporting Trials guidelines.19 An untreated control group was not included because of ethical reasons.
Participants, eligibility criteria, and settings
The Ethics in Research Committee of Bauru Dental School, University of São Paulo, Bauru, Brazil approved the study (protocol no. 68551617.8.0000.5417/2.112.035). The protocol was registered at Clinicaltrials.gov with the identifier NCT03702881. Subjects’
Participant flow
During recruitment (June 2017 to April 2018), 1025 children were assessed for eligibility. From this sample, 969 were excluded because they did not meet the selection criteria, and 6 declined to participate in the study. Fifty patients were randomized in a 1:1 ratio (Fig 3).
Baseline data
The groups showed similar age and sex distribution (Table II). Baseline characteristics were also similar in both groups (Table III).
Number analyzed for each outcome, estimation, and precision
The SBU group had 1 patient (4%) lost to follow-up because the patient moved to another
Main findings in the context of the existing evidence and interpretation
Digital dental model assessment after AOB treatment allows evaluation of specific tooth areas that are, sometimes, difficult to visualize in lateral cephalograms because of the superimposition of dental structures. Few studies have reported the treatment changes of AOB after crib therapy using dental models.18,27 The present study is the first randomized clinical trial evaluating the dimensional changes of the dental arches after AOB early treatment with bonded spurs and posterior build-ups by
Conclusions
After a 12-month treatment period:
- 1.
Both treatment protocols showed similar overbite increases, anterior dentoalveolar vertical development, clinical crown height increases, and similar decreases of the arch perimeters and lengths.
- 2.
Bonded spurs associated with posterior build-ups showed a slight decrease in the maxillary intermolar distance and a slight increase in the mandibular intermolar distance, whereas opposite changes were observed when bonded spurs were used alone.
Author Credit Statement
Aron Aliaga-Del Castillo contributed to conceptualization, methodology, investigation, resources, data curation, original draft preparation, visualization, project administration, funding acquisition; Silvio Augusto Bellini-Pereira contributed to the methodology, validation, investigation, resources, original draft preparation, and visualization. Lorena Vilanova contributed to the investigation, resources, original draft preparation; Felicia Miranda contributed to the investigation, resources,
Acknowledgments
The authors thank Dr Bruno Gribel (Compass 3D; Belo Horizonte, Minas Gerais, Brazil), FGM Dental Products (Joinville, Santa Catarina, Brazil), and Morelli (Sorocaba, São Paulo, Brazil) for their support in the present study.
This work was supported by the São Paulo Research Foundation (FAPESP), grants nos. 2017/06440-3, 2018/05238-9 and 2018/24003-2; and financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001.
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All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest, and none were reported.
This work was supported by the São Paulo Research Foundation (FAPESP) grants nos. 2017/06440-3, 2018/05238-9, and 2018/24003-2; and financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (CAPES), Finance Code 001.
This article is based on research submitted by Aron Aliaga-Del Castillo in partial fulfillment of the requirements for the degree of PhD in Orthodontics at Bauru Dental School, University of São Paulo, Bauru, Brazil.