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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702881
• Other study ID #: 68551617.8.0000.5417
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: April 15, 2020

Study information

• Verified date: May 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Open Bite

Intervention

Device:
• Bonded Spurs associated with posterior build-ups
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
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.

Locations

Country	Name	City	State
Brazil	Bauru Dental School, University of São Paulo	Bauru	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overbite (mm)		12 months
Primary	Gonial angle (º)		12 months
Primary	Mandibular plane angle (º)		12 months
Primary	Maxillary and mandibular molar vertical development (mm)		12 months
Secondary	Overbite (mm)		24 months
Secondary	Gonial angle (º)		24 months
Secondary	Mandibular plane angle (º)		24 months
Secondary	Maxillary and mandibular molar vertical development (mm)		24 months
Secondary	Maxillary and mandibular position (º)		12 months
Secondary	Maxillary and mandibular position (º)		24 months
Secondary	Maxillary and mandibular length (mm)		12 months
Secondary	Maxillary and mandibular length (mm)		24 months
Secondary	Mandibular ramus height (mm)		12 months
Secondary	Mandibular ramus height (mm)		24 months
Secondary	Sagittal skeletal discrepancy (º)		12 months
Secondary	Sagittal skeletal discrepancy (º)		24 months
Secondary	Facial axis angle (º)		12 months
Secondary	Facial axis angle (º)		24 months
Secondary	Maxillomandibular divergence angle (º)		12 months
Secondary	Maxillomandibular divergence angle (º)		24 months
Secondary	Palatal plane inclination (º)		12 months
Secondary	Palatal plane inclination (º)		24 months
Secondary	Anterior face height (mm)		12 months
Secondary	Anterior face height (mm)		24 months
Secondary	Posterior face height (mm)		12 months
Secondary	Posterior face height (mm)		24 months
Secondary	Lower anterior face height (mm)		12 months
Secondary	Lower anterior face height (mm)		24 months
Secondary	Overjet (mm)		12 months
Secondary	Overjet (mm)		24 months
Secondary	Maxillary and mandibular incisors Inclination (º)		12 months
Secondary	Maxillary and mandibular incisors Inclination (º)		24 months
Secondary	Maxillary and mandibular incisors position (mm)		12 months
Secondary	Maxillary and mandibular incisors position (mm)		24 months
Secondary	Maxillary and mandibular incisors height (mm)		12 months
Secondary	Maxillary and mandibular incisors height (mm)		24 months
Secondary	Nasolabial angle (º)		12 months
Secondary	Nasolabial angle (º)		24 months
Secondary	Upper lip inclination (º)		12 months
Secondary	Upper lip inclination (º)		24 months
Secondary	Upper and lower lip position (mm)		12 months
Secondary	Upper and lower lip position (mm)		24 months
Secondary	Interlabial gap (mm)		12 months
Secondary	Interlabial gap (mm)		24 months
Secondary	Maxillary and mandibular anterior dentoalveolar vertical development (mm)		12 months
Secondary	Maxillary and mandibular anterior dentoalveolar vertical development (mm)		24 months
Secondary	Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)		12 months
Secondary	Bucco-lingual inclinations of maxillary and mandibular permanent first molars (º)		24 months
Secondary	Maxillary and mandibular inter-first permanent molar distances (mm)		12 months
Secondary	Maxillary and mandibular inter-first permanent molar distances (mm)		24 months
Secondary	Maxillary and mandibular inter-canine distances (mm)		12 months
Secondary	Maxillary and mandibular inter-canine distances (mm)		24 months
Secondary	Maxillary and mandibular arch perimeters (mm)		12 months
Secondary	Maxillary and mandibular arch perimeters (mm)		24 months
Secondary	Maxillary and mandibular arch lengths (mm)		12 months
Secondary	Maxillary and mandibular arch lengths (mm)		24 months
Secondary	Palatal depth (mm)		12 months
Secondary	Palatal depth (mm)		24 months
Secondary	Dentoalveolar displacements obtained from three-dimensional superimposition (mm)		12 months
Secondary	Dentoalveolar displacements obtained from three-dimensional superimposition (mm)		24 months
Secondary	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.	1 month
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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.	1 month
Secondary	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.	12 months
Secondary	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.	24 months