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MalocclusionNCT03702881

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

A study testing Bonded Spurs associated with posterior build-ups and Conventional bonded spurs in people with Malocclusion and Open Bite, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 11 years
Conditions the study is for
Malocclusion, Open Bite
What is being tested?
Bonded Spurs associated with posterior build-ups and Conventional bonded spurs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
9 Jun 2017to 15 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Bauru Dental School, University of São Paulo

    Bauru, São Paulo, 17012901

Other trials in Brazil

About this study

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

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.

Read the detailed description

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.

Being tested
Bonded Spurs associated with posterior build-ups, Conventional bonded spurs
Keywords
Open Bite, Orthodontic appliance, Cephalometry, Dental models
Medical subject headings
Malocclusion, Open Bite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bonded Spurs associated with posterior build-upsDevice

    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 spursDevice

    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.

Study groups in NCT03702881
Study groupRoleWhat they receive
Bonded Spurs associated with posterior build-ups GroupExperimentalThe experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.
Receives: Device: Bonded Spurs associated with posterior build-ups
Conventional bonded spurs GroupActive comparatorActive comparator group will consist of 25 patients treated with conventional bonded spurs
Receives: Device: Conventional bonded spurs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overbite (mm)

    Measured: 12 months

  2. Gonial angle (º)

    Measured: 12 months

  3. Mandibular plane angle (º)

    Measured: 12 months

  4. Maxillary and mandibular molar vertical development (mm)

    Measured: 12 months

Secondary outcomes (62)

  1. Overbite (mm)

    Measured: 24 months

  2. Gonial angle (º)

    Measured: 24 months

  3. Mandibular plane angle (º)

    Measured: 24 months

  4. Maxillary and mandibular molar vertical development (mm)

    Measured: 24 months

  5. Maxillary and mandibular position (º)

    Measured: 12 months

  6. Maxillary and mandibular position (º)

    Measured: 24 months

  7. Maxillary and mandibular length (mm)

    Measured: 12 months

  8. Maxillary and mandibular length (mm)

    Measured: 24 months

  9. Mandibular ramus height (mm)

    Measured: 12 months

  10. Mandibular ramus height (mm)

    Measured: 24 months

  11. Sagittal skeletal discrepancy (º)

    Measured: 12 months

  12. Sagittal skeletal discrepancy (º)

    Measured: 24 months

  13. Facial axis angle (º)

    Measured: 12 months

  14. Facial axis angle (º)

    Measured: 24 months

  15. Maxillomandibular divergence angle (º)

    Measured: 12 months

  16. Maxillomandibular divergence angle (º)

    Measured: 24 months

  17. Palatal plane inclination (º)

    Measured: 12 months

  18. Palatal plane inclination (º)

    Measured: 24 months

  19. Anterior face height (mm)

    Measured: 12 months

  20. Anterior face height (mm)

    Measured: 24 months

  21. Posterior face height (mm)

    Measured: 12 months

  22. Posterior face height (mm)

    Measured: 24 months

  23. Lower anterior face height (mm)

    Measured: 12 months

  24. Lower anterior face height (mm)

    Measured: 24 months

  25. Overjet (mm)

    Measured: 12 months

  26. Overjet (mm)

    Measured: 24 months

  27. Maxillary and mandibular incisors Inclination (º)

    Measured: 12 months

  28. Maxillary and mandibular incisors Inclination (º)

    Measured: 24 months

  29. Maxillary and mandibular incisors position (mm)

    Measured: 12 months

  30. Maxillary and mandibular incisors position (mm)

    Measured: 24 months

  31. Maxillary and mandibular incisors height (mm)

    Measured: 12 months

  32. Maxillary and mandibular incisors height (mm)

    Measured: 24 months

  33. Nasolabial angle (º)

    Measured: 12 months

  34. Nasolabial angle (º)

    Measured: 24 months

  35. Upper lip inclination (º)

    Measured: 12 months

  36. Upper lip inclination (º)

    Measured: 24 months

  37. Upper and lower lip position (mm)

    Measured: 12 months

  38. Upper and lower lip position (mm)

    Measured: 24 months

  39. Interlabial gap (mm)

    Measured: 12 months

  40. Interlabial gap (mm)

    Measured: 24 months

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

    Measured: 12 months

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

    Measured: 24 months

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

    Measured: 12 months

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

    Measured: 24 months

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

    Measured: 12 months

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

    Measured: 24 months

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

    Measured: 12 months

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

    Measured: 24 months

  49. Maxillary and mandibular arch perimeters (mm)

    Measured: 12 months

  50. Maxillary and mandibular arch perimeters (mm)

    Measured: 24 months

  51. Maxillary and mandibular arch lengths (mm)

    Measured: 12 months

  52. Maxillary and mandibular arch lengths (mm)

    Measured: 24 months

  53. Palatal depth (mm)

    Measured: 12 months

  54. Palatal depth (mm)

    Measured: 24 months

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

    Measured: 12 months

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

    Measured: 24 months

  57. Discomfort and pain intensity evaluated with questionnaires

    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.

    Measured: 1 month

  58. Discomfort and pain intensity evaluated with questionnaires

    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.

    Measured: 12 months

  59. Discomfort and pain intensity evaluated with questionnaires

    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.

    Measured: 24 months

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

    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.

    Measured: 1 month

  61. Quality of life evaluation with questionnaires

    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.

    Measured: 12 months

  62. Quality of life evaluation with questionnaires

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start9 Jun 2017
  3. Primary completion15 Apr 2019
  4. Study completion15 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03702881
Sponsor's protocol ID
68551617.8.0000.5417
Status last verified
May 2021
First submitted
7 Oct 2018
Last updated
12 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aliaga-Del Castillo A, Maranon-Vasquez GA, Janson G, Vilanova L, Miranda F, Massaro C, Bellini-Pereira SA, Arriola-Guillen LE, Yatabe M, Ruellas AC, Cevidanes L, Garib D. Oral health-related quality of life, adaptation/discomfort during open bite treatment with spurs: complementary analysis from a randomized clinical trial. Sci Rep. 2024 Mar 8;14(1):5732. doi: 10.1038/s41598-024-56363-0.

    PubMed 38459254

  • Aliaga-Del Castillo A, Janson G, Vilanova L, Cevidanes L, Yatabe M, Garib D, Arriola-Guillen LE, Miranda F, Massaro C, Bellini-Pereira SA, Ruellas AC. Three-dimensional dentoalveolar changes in open bite treatment in mixed dentition, spurs/posterior build-ups versus spurs alone: 1-year follow-up randomized clinical trial. Sci Rep. 2022 Jul 20;12(1):12378. doi: 10.1038/s41598-022-15988-9.

    PubMed 35858941

  • Aliaga-Del Castillo A, Bellini-Pereira SA, Vilanova L, Miranda F, Massaro C, Arriola-Guillen LE, Garib D, Janson G. Dental arch changes after open bite treatment with spurs associated with posterior build-ups in the mixed dentition: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Jun;159(6):714-723.e1. doi: 10.1016/j.ajodo.2020.11.036. Epub 2021 Mar 30.

    PubMed 33795189

  • Aliaga-Del Castillo A, Vilanova L, Miranda F, Arriola-Guillen LE, Garib D, Janson G. Dentoskeletal changes in open bite treatment using spurs and posterior build-ups: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Jan;159(1):10-20. doi: 10.1016/j.ajodo.2020.06.031. Epub 2020 Nov 18.

    PubMed 33221096

Questions about this trial

What is this clinical trial studying?

A study testing Bonded Spurs associated with posterior build-ups and Conventional bonded spurs in people with Malocclusion and Open Bite, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overbite (mm) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03702881, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.

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