Randomized controlled trial
Dentoskeletal changes in open bite treatment using spurs and posterior build-ups: A randomized clinical trial

https://doi.org/10.1016/j.ajodo.2020.06.031Get rights and content

Highlights

  • Two protocols for anterior open bite treatment in children were evaluated.

  • Treatment with spurs and posterior build-ups was compared with treatment with spurs alone.

  • Overbite increase was similar.

  • The experimental group showed smaller maxillary molar extrusion and similar counterclockwise rotation of the mandible.

Introduction

This single-center 2-arm parallel randomized clinical trial aimed to compare the dentoskeletal effects of bonded spurs combined with posterior build-ups vs conventional bonded spurs in the treatment of anterior open bite malocclusion in the mixed dentition.

Methods

Patients aged from 7 to 11 years with anterior open bite, recruited at a university orthodontic clinic, were randomly allocated into 2 groups. The experimental group consisted of patients treated with bonded spurs combined with posterior build-ups. The comparison group comprised patients treated with conventional bonded spurs. Lateral headfilms were obtained at pretreatment and after 12 months of treatment. The primary outcome was the change in the overbite. Randomization was performed using the Web site www.randomization.com. Sequentially numbered opaque and sealed envelopes were used for allocation concealment. Blinding was applicable for outcome assessment only. Intergroup comparisons were performed using t or Mann-Whitney U tests (P <0.05). Mean difference (MD) and 95% confidence interval (CI) were obtained.

Results

The experimental group included 24 patients (17 female, 7 male; mean age, 8.22 ± 1.06 years) and the comparison group comprised 25 patients (14 female, 11 male; mean age, 8.30 ± 0.99 years). Baseline demographic and cephalometric characteristics were similar between groups. After 12 months, all patients showed improvements. Both groups showed similar improvements of the overbite (MD, 0.00 mm; 95% CI, −0.92 to 0.91), similar slight decreases of the gonial (MD, 0.02°; 95% CI, −1.11 to 1.15) and mandibular plane (MD, 0.15°; 95% CI, −0.64 to 0.93) angles, and similar mandibular molar extrusion (MD, 0.14 mm; 95% CI, −0.27 to 0.56). The experimental group showed significantly smaller extrusion of the maxillary first molar than the comparison group (MD, −0.70 mm; 95% CI, −0.92 to −0.49). The other dentoskeletal variables showed similar changes without statistically significant intergroup differences. No serious harm was observed other than plaque accumulation around the spurs.

Conclusions

Similar overbite increases and dentoskeletal changes were observed in both groups after 12 months of treatment. Although the experimental group showed significantly smaller extrusion of the maxillary molars, no greater counterclockwise rotation of the mandible than the comparison group was observed.

Registration

This trial was registered at Clinicaltrials.gov (Identifier NCT03702881).

Protocol

The protocol was not published.

Funding

This trial was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES), Finance Code 001; and by grants: no. 2017/06440-3, no. 2018/05238-9 and no. 2018/24003-2, São Paulo Research Foundation (FAPESP).

Section snippets

Specific objectives or hypotheses

This study aimed to compare the dentoskeletal changes of bonded spurs combined with posterior build-ups vs conventional bonded spurs in anterior open bite early treatment. The null hypothesis tested was that both therapies produce similar dentoskeletal effects.

Trial design and any changes after trial commencement

This project was a single-center RCT with 2 parallel arms and a 1:1 allocation ratio. This RCT followed the Consolidated Standards of Reporting Trials statement and guidelines,21 and did not require changes in methods after trial commencement.

Participants, eligibility criteria, and settings

This study was approved by the Ethics in Research Committee of Bauru Dental School, University of São Paulo, Bauru, Brazil (protocol no. 68551617.8.0000.5417/2.112.035). In addition, the protocol of this study was registered at Clinicaltrials.gov with the

Participant flow

A total of 1025 children were assessed for eligibility; 969 were excluded because they did not meet the inclusion criteria, and 6 declined to participate. Fifty patients were randomized in a 1:1 ratio (Fig 2).

Baseline data

The groups showed similar characteristics regarding age and sex distribution and initial cephalometric variables (Tables II and III; Fig 3, A).

Number analyzed for each outcome, estimation, and precision

One out of 25 patients (4%) was lost during the follow-up in the experimental group because the patient moved to another city. Considering that the

Main findings in the context of the existing evidence and interpretation

Early treatment of anterior open bite malocclusion has been studied, and different protocols were reported to treat this condition.10, 11, 12,14, 15, 16, 17,23,28, 29, 30 However, RCT evaluating conventional and new associated protocols are still necessary.6, 7, 8, 9

Previous studies have reported the efficiency of bonded spurs alone for early treatment of anterior open bite.10, 11, 12 Bonded spurs combined with posterior build-ups could produce a combined effect of eliminating deleterious

Conclusions

  • 1.

    Both treatment protocols produced similar overbite increases and showed similar dentoskeletal changes after 12 months of treatment.

  • 2.

    Although the bonded spurs combined with posterior build-ups showed significantly smaller extrusion of the maxillary molars, no greater counterclockwise rotation of the mandible was observed in comparison with conventional bonded spurs alone in the short term.

Acknowledgments

This trial was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES), Finance Code 001; and by grants: no. 2017/06440-3, no. 2018/05238-9 and no. 2018/24003-2, São Paulo Research Foundation (FAPESP).

The authors thank Morelli (Sorocaba, São Paulo, Brazil) and FGM Dental Products (Joinville, Santa Catarina, Brazil) for their support.

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  • Cited by (6)

    • Effects of bonded spurs, fixed and removable palatal crib in the early treatment of anterior open bite: A systematic review and meta-analysis

      2023, American Journal of Orthodontics and Dentofacial Orthopedics
      Citation Excerpt :

      Mucedero et al28 compared quad-helix with crib appliances with the combined use of 3 appliances, that is, transpalatal arch, high-pull headgear, and lip bumper, in treating AOB. Bonded spurs associated with posterior build-ups and bonded spurs alone were assessed in 2 articles.29,30 Dental arch changes after AOB treatment produced by the miniscrew-supported palatal crib and conventional fixed palatal crib were evaluated by Fouda.31

    • Authors’ response

      2022, American Journal of Orthodontics and Dentofacial Orthopedics
    • Dental arch changes after open bite treatment with spurs associated with posterior build-ups in the mixed dentition: A randomized clinical trial

      2021, American Journal of Orthodontics and Dentofacial Orthopedics
      Citation Excerpt :

      Some patients in both groups still had a residual AOB at T2 and continued with bonded spurs for a longer time. This has been reported in previous studies and was related to the initial AOB severity, associated with greater skeletal vertical involvement at pretreatment, a short-term follow-up period, and persistence of some oral habits (thumb/finger sucking, pacifier, and tongue habits).9,10,13,28 Further research with greater samples should be planned to confirm our results.

    All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest, and none were reported.

    This trial was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brasil (CAPES), Finance Code 001; and by grants: no. 2017/06440-3, no. 2018/05238-9 and no. 2018/24003-2, São Paulo Research Foundation (FAPESP).

    This article is based on research submitted by Dr 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.

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