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Completed

NCT Number: NCT03702881

Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs

This study compares the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients. Half of participants will be treated with bonded spurs associated with build-ups, while the other half will be treated with conventional bonded spurs.

The null hypothesis to be tested is that there are no differences for the dentoalveolar and skeletal effects between the two protocols.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru Dental School, University of São Paulo

Bauru, São Paulo, 17012901, Brazil

About this study

Anterior open bite is commonly related with lower anterior face height increase. Some early treatment protocols use appliances that control deleterious habits associated to appliances that produce control of the vertical dimension. Usually, these appliances (chincup, removable orthopedics) depend on patient's collaboration. Recently, the efficiency and stability of anterior open bite treatment with resin blocks bonded to the posterior teeth (build-ups) associated with fixed orthodontic appliances was described. They could be considered as a promissory alternative for vertical control during anterior open bite treatment. Then, it could be thought that the association of bonded spurs with posterior build-ups, instead of chincup, would produce vertical control during anterior open bite early treatment without the need of patient collaboration. Therefore, the aim of this study is to compare the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients.

For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. Fifty patients between 7 and 11 years old diagnosed with anterior open bite greater than 1 mm will be prospective and randomly allocated in one of the two study group. The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups. Control group will consist of 25 patients treated with conventional bonded spurs.

Lateral radiographs and digital dental models will be obtained at the beginning (T1), 12 months after treatment (T2), and 24 months after treatment (T3). Dentoalveolar and skeletal variables will be evaluated from the lateral radiographs in the Dolphin® software. Dental casts will be analyzed with the Orthoanalyzer® software to evaluate dentoalveolar anterior vertical development, posterior teeth inclinations and arch dimensions. Superimposition of digital dental models will be performed to evaluate the relative three-dimensional dentoalveolar changes on the maxillary and mandibular arches. Discomfort, pain and quality of life will be evaluated using questionnaires.

After verifying the normal distribution, intergroup comparisons (T1 vs T2 and T1 vs T3) will be performed with t test and intragroup comparisons with dependent t test. Results will be considered statistically significant at P<0.05.

The possible harms that could appear with these therapies are related to temporary tongue discomfort during the first days after the installation of the appliances. Patients and parents will be informed that is it normal. Although it has been reported that the discomfort is temporary and transitory and usually patients adapted to the treatment after 3-5 days, patients or parents will be able to stop the treatment at any moment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 7 to 11 years old,
  • erupted permanent first permanent molars,
  • anterior open bite (AOB) greater than 1 mm,
  • maxillary and mandibular permanent central incisors fully erupted,
  • no or mild crowding,
  • without the need of maxillary expansion
  • Children in the first transitional period will be considered to be eligible for treatment when the maxillary lateral incisors are beginning to erupt and the maxillary central incisors still show an open bite

Exclusion criteria

  • previous orthodontic treatment,
  • craniofacial anomalies or syndromes,
  • tooth agenesis,
  • loss of permanent teeth,
  • severe crowding,
  • maxillary constriction or posterior crossbite

Treatment and study plan

Bonded Spurs associated with posterior build-ups

Device

Twenty-five patients will be treated with bonded spurs associated with posterior build-ups. The cervical portion of the palatal surfaces of the maxillary incisors and the incisal portion of the lingual surfaces of the mandibular incisors will be pumiced, rinsed, dried, and acid etched with 37% phosphoric acid. The etched surfaces will be subsequently rinsed and carefully dried. Then, the spurs will be bonded using Transbond primer/adhesive. The positions for the spurs will be chose to prevent possible future occlusal interferences The spurs will be sharpened with a carborundum disk before bonding. In addition, posterior build-ups (resin blocks) will be cemented on the functional cusps of all maxillary posterior teeth. The treatment time will be 12 months. After this time, the posterior build ups will be removed and the bonded spurs will be maintained for 12 months more, as active retention.

Conventional bonded spurs

Device

Twenty-five patients will be treated only with bonded spurs. The bonding of the spurs will follow the same protocol described for the experimental group. The treatment time will be 12 months. After this time, the bonded spurs will be maintained for 12 months more, as active retention.

Primary outcomes

  1. Overbite (mm)

    Time frame: 12 months

  2. Gonial angle (º)

    Time frame: 12 months

  3. Mandibular plane angle (º)

    Time frame: 12 months

  4. Maxillary and mandibular molar vertical development (mm)

    Time frame: 12 months

Secondary outcomes

  1. Overbite (mm)

    Time frame: 24 months

  2. Gonial angle (º)

    Time frame: 24 months

  3. Mandibular plane angle (º)

    Time frame: 24 months

  4. Maxillary and mandibular molar vertical development (mm)

    Time frame: 24 months

  5. Maxillary and mandibular position (º)

    Time frame: 12 months

  6. Maxillary and mandibular position (º)

    Time frame: 24 months

  7. Maxillary and mandibular length (mm)

    Time frame: 12 months

  8. Maxillary and mandibular length (mm)

    Time frame: 24 months

  9. Mandibular ramus height (mm)

    Time frame: 12 months

  10. Mandibular ramus height (mm)

    Time frame: 24 months

  11. Sagittal skeletal discrepancy (º)

    Time frame: 12 months

  12. Sagittal skeletal discrepancy (º)

    Time frame: 24 months

  13. Facial axis angle (º)

    Time frame: 12 months

  14. Facial axis angle (º)

    Time frame: 24 months

  15. Maxillomandibular divergence angle (º)

    Time frame: 12 months

  16. Maxillomandibular divergence angle (º)

    Time frame: 24 months

  17. Palatal plane inclination (º)

    Time frame: 12 months

  18. Palatal plane inclination (º)

    Time frame: 24 months

  19. Anterior face height (mm)

    Time frame: 12 months

  20. Anterior face height (mm)

    Time frame: 24 months

  21. Posterior face height (mm)

    Time frame: 12 months

  22. Posterior face height (mm)

    Time frame: 24 months

  23. Lower anterior face height (mm)

    Time frame: 12 months

  24. Lower anterior face height (mm)

    Time frame: 24 months

  25. Overjet (mm)

    Time frame: 12 months

  26. Overjet (mm)

    Time frame: 24 months

  27. Maxillary and mandibular incisors Inclination (º)

    Time frame: 12 months

  28. Maxillary and mandibular incisors Inclination (º)

    Time frame: 24 months

  29. Maxillary and mandibular incisors position (mm)

    Time frame: 12 months

  30. Maxillary and mandibular incisors position (mm)

    Time frame: 24 months

  31. Maxillary and mandibular incisors height (mm)

    Time frame: 12 months

  32. Maxillary and mandibular incisors height (mm)

    Time frame: 24 months

  33. Nasolabial angle (º)

    Time frame: 12 months

  34. Nasolabial angle (º)

    Time frame: 24 months

  35. Upper lip inclination (º)

    Time frame: 12 months

  36. Upper lip inclination (º)

    Time frame: 24 months

  37. Upper and lower lip position (mm)

    Time frame: 12 months

  38. Upper and lower lip position (mm)

    Time frame: 24 months

  39. Interlabial gap (mm)

    Time frame: 12 months

  40. Interlabial gap (mm)

    Time frame: 24 months

  41. Maxillary and mandibular anterior dentoalveolar vertical development (mm)

    Time frame: 12 months

  42. Maxillary and mandibular anterior dentoalveolar vertical development (mm)

    Time frame: 24 months

  43. Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)

    Time frame: 12 months

  44. Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)

    Time frame: 24 months

  45. Maxillary and mandibular inter-first permanent molar distances (mm)

    Time frame: 12 months

  46. Maxillary and mandibular inter-first permanent molar distances (mm)

    Time frame: 24 months

  47. Maxillary and mandibular inter-canine distances (mm)

    Time frame: 12 months

  48. Maxillary and mandibular inter-canine distances (mm)

    Time frame: 24 months

  49. Maxillary and mandibular arch perimeters (mm)

    Time frame: 12 months

  50. Maxillary and mandibular arch perimeters (mm)

    Time frame: 24 months

  51. Maxillary and mandibular arch lengths (mm)

    Time frame: 12 months

  52. Maxillary and mandibular arch lengths (mm)

    Time frame: 24 months

  53. Palatal depth (mm)

    Time frame: 12 months

  54. Palatal depth (mm)

    Time frame: 24 months

  55. Dentoalveolar displacements obtained from three-dimensional superimposition (mm)

    Time frame: 12 months

  56. Dentoalveolar displacements obtained from three-dimensional superimposition (mm)

    Time frame: 24 months

  57. Discomfort and pain intensity evaluated with questionnaires

    Time frame: 1 month

    A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.

  58. Discomfort and pain intensity evaluated with questionnaires

    Time frame: 12 months

    A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.

  59. Discomfort and pain intensity evaluated with questionnaires

    Time frame: 24 months

    A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.

  60. Parent´s perception of children discomfort and pain intensity evaluated with questionnaires

    Time frame: 1 month

    A 10-cm Visual Analog Scale will be used, where "0-cm" is the minimum score indicating nor discomfort or pain intensity and "10-cm" is the maximum score denoting the greatest discomfort or pain intensity.

  61. Quality of life evaluation with questionnaires

    Time frame: 12 months

    Oral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from "0" indicating no impact of oral condition on quality of life, to "100" indicating maximal impact of oral condition on quality of life.

  62. Quality of life evaluation with questionnaires

    Time frame: 24 months

    Oral health related-quality of life evaluation will be performed with the Child Perceptions Questionnaire (CPQ8-10). The questionnaire contains 25 items distributed in four domains: oral symptoms, functional limitations, emotional wellbeing and social wellbeing. The items assess the frequency of the events that occurs in the four weeks previous to the application of the questionnaire. A 5-point Likert scale is used with the options: Never (0), Once/twice (1), Sometimes (2), Often (3), and Every day/almost every day (4). The CPQ8-10 scores are obtained by summing all item scores. The total score ranges from "0" indicating no impact of oral condition on quality of life, to "100" indicating maximal impact of oral condition on quality of life.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 11, 2018
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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