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

Primary Purpose

Malocclusion, Open Bite

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bonded Spurs associated with posterior build-ups
Conventional bonded spurs
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Open Bite, Orthodontic appliance, Cephalometry, Dental models

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bauru Dental School, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bonded Spurs associated with posterior build-ups Group

Conventional bonded spurs Group

Arm Description

The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.

Active comparator group will consist of 25 patients treated with conventional bonded spurs

Outcomes

Primary Outcome Measures

Overbite (mm)
Gonial angle (º)
Mandibular plane angle (º)
Maxillary and mandibular molar vertical development (mm)

Secondary Outcome Measures

Overbite (mm)
Gonial angle (º)
Mandibular plane angle (º)
Maxillary and mandibular molar vertical development (mm)
Maxillary and mandibular position (º)
Maxillary and mandibular position (º)
Maxillary and mandibular length (mm)
Maxillary and mandibular length (mm)
Mandibular ramus height (mm)
Mandibular ramus height (mm)
Sagittal skeletal discrepancy (º)
Sagittal skeletal discrepancy (º)
Facial axis angle (º)
Facial axis angle (º)
Maxillomandibular divergence angle (º)
Maxillomandibular divergence angle (º)
Palatal plane inclination (º)
Palatal plane inclination (º)
Anterior face height (mm)
Anterior face height (mm)
Posterior face height (mm)
Posterior face height (mm)
Lower anterior face height (mm)
Lower anterior face height (mm)
Overjet (mm)
Overjet (mm)
Maxillary and mandibular incisors Inclination (º)
Maxillary and mandibular incisors Inclination (º)
Maxillary and mandibular incisors position (mm)
Maxillary and mandibular incisors position (mm)
Maxillary and mandibular incisors height (mm)
Maxillary and mandibular incisors height (mm)
Nasolabial angle (º)
Nasolabial angle (º)
Upper lip inclination (º)
Upper lip inclination (º)
Upper and lower lip position (mm)
Upper and lower lip position (mm)
Interlabial gap (mm)
Interlabial gap (mm)
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Maxillary and mandibular inter-first permanent molar distances (mm)
Maxillary and mandibular inter-first permanent molar distances (mm)
Maxillary and mandibular inter-canine distances (mm)
Maxillary and mandibular inter-canine distances (mm)
Maxillary and mandibular arch perimeters (mm)
Maxillary and mandibular arch perimeters (mm)
Maxillary and mandibular arch lengths (mm)
Maxillary and mandibular arch lengths (mm)
Palatal depth (mm)
Palatal depth (mm)
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2018
Last Updated
May 11, 2021
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03702881
Brief Title
Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs
Official Title
Anterior Open Bite Treatment With Bonded Spurs Associated With Build-ups Versus Conventional Bonded Spurs: a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Open Bite
Keywords
Open Bite, Orthodontic appliance, Cephalometry, Dental models

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bonded Spurs associated with posterior build-ups Group
Arm Type
Experimental
Arm Description
The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.
Arm Title
Conventional bonded spurs Group
Arm Type
Active Comparator
Arm Description
Active comparator group will consist of 25 patients treated with conventional bonded spurs
Intervention Type
Device
Intervention Name(s)
Bonded Spurs associated with posterior build-ups
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional bonded spurs
Intervention Description
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 Outcome Measure Information:
Title
Overbite (mm)
Time Frame
12 months
Title
Gonial angle (º)
Time Frame
12 months
Title
Mandibular plane angle (º)
Time Frame
12 months
Title
Maxillary and mandibular molar vertical development (mm)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overbite (mm)
Time Frame
24 months
Title
Gonial angle (º)
Time Frame
24 months
Title
Mandibular plane angle (º)
Time Frame
24 months
Title
Maxillary and mandibular molar vertical development (mm)
Time Frame
24 months
Title
Maxillary and mandibular position (º)
Time Frame
12 months
Title
Maxillary and mandibular position (º)
Time Frame
24 months
Title
Maxillary and mandibular length (mm)
Time Frame
12 months
Title
Maxillary and mandibular length (mm)
Time Frame
24 months
Title
Mandibular ramus height (mm)
Time Frame
12 months
Title
Mandibular ramus height (mm)
Time Frame
24 months
Title
Sagittal skeletal discrepancy (º)
Time Frame
12 months
Title
Sagittal skeletal discrepancy (º)
Time Frame
24 months
Title
Facial axis angle (º)
Time Frame
12 months
Title
Facial axis angle (º)
Time Frame
24 months
Title
Maxillomandibular divergence angle (º)
Time Frame
12 months
Title
Maxillomandibular divergence angle (º)
Time Frame
24 months
Title
Palatal plane inclination (º)
Time Frame
12 months
Title
Palatal plane inclination (º)
Time Frame
24 months
Title
Anterior face height (mm)
Time Frame
12 months
Title
Anterior face height (mm)
Time Frame
24 months
Title
Posterior face height (mm)
Time Frame
12 months
Title
Posterior face height (mm)
Time Frame
24 months
Title
Lower anterior face height (mm)
Time Frame
12 months
Title
Lower anterior face height (mm)
Time Frame
24 months
Title
Overjet (mm)
Time Frame
12 months
Title
Overjet (mm)
Time Frame
24 months
Title
Maxillary and mandibular incisors Inclination (º)
Time Frame
12 months
Title
Maxillary and mandibular incisors Inclination (º)
Time Frame
24 months
Title
Maxillary and mandibular incisors position (mm)
Time Frame
12 months
Title
Maxillary and mandibular incisors position (mm)
Time Frame
24 months
Title
Maxillary and mandibular incisors height (mm)
Time Frame
12 months
Title
Maxillary and mandibular incisors height (mm)
Time Frame
24 months
Title
Nasolabial angle (º)
Time Frame
12 months
Title
Nasolabial angle (º)
Time Frame
24 months
Title
Upper lip inclination (º)
Time Frame
12 months
Title
Upper lip inclination (º)
Time Frame
24 months
Title
Upper and lower lip position (mm)
Time Frame
12 months
Title
Upper and lower lip position (mm)
Time Frame
24 months
Title
Interlabial gap (mm)
Time Frame
12 months
Title
Interlabial gap (mm)
Time Frame
24 months
Title
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Time Frame
12 months
Title
Maxillary and mandibular anterior dentoalveolar vertical development (mm)
Time Frame
24 months
Title
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Time Frame
12 months
Title
Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)
Time Frame
24 months
Title
Maxillary and mandibular inter-first permanent molar distances (mm)
Time Frame
12 months
Title
Maxillary and mandibular inter-first permanent molar distances (mm)
Time Frame
24 months
Title
Maxillary and mandibular inter-canine distances (mm)
Time Frame
12 months
Title
Maxillary and mandibular inter-canine distances (mm)
Time Frame
24 months
Title
Maxillary and mandibular arch perimeters (mm)
Time Frame
12 months
Title
Maxillary and mandibular arch perimeters (mm)
Time Frame
24 months
Title
Maxillary and mandibular arch lengths (mm)
Time Frame
12 months
Title
Maxillary and mandibular arch lengths (mm)
Time Frame
24 months
Title
Palatal depth (mm)
Time Frame
12 months
Title
Palatal depth (mm)
Time Frame
24 months
Title
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Time Frame
12 months
Title
Dentoalveolar displacements obtained from three-dimensional superimposition (mm)
Time Frame
24 months
Title
Discomfort and pain intensity evaluated with questionnaires
Description
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.
Time Frame
1 month
Title
Discomfort and pain intensity evaluated with questionnaires
Description
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.
Time Frame
12 months
Title
Discomfort and pain intensity evaluated with questionnaires
Description
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.
Time Frame
24 months
Title
Parent´s perception of children discomfort and pain intensity evaluated with questionnaires
Description
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.
Time Frame
1 month
Title
Quality of life evaluation with questionnaires
Description
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.
Time Frame
12 months
Title
Quality of life evaluation with questionnaires
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bauru Dental School, University of São Paulo
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35858941
Citation
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.
Results Reference
derived
PubMed Identifier
33795189
Citation
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.
Results Reference
derived
PubMed Identifier
33221096
Citation
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.
Results Reference
derived

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

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