Orthodontic Approaches to Correct Deep Bite in Mixed Dentition Patients

NCT03641196 | Terminated

• 1 other identifier: Pro00082429
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

A deep bite is a bite where the upper front teeth cover almost all, if not all the lower front teeth. Currently there is no clarity which of the available treatment approaches is better when these patients still have some baby (deciduous) teeth in their mouths. This study will compare the results of four ways to manage this problem:

1. 1.Delay treatment until all permanent teeth are erupted,
2. 2.Temporary glue some brackets to the upper front teeth and correct the problem with orthodontic wires,
3. 3.Temporary glue some dental material in the back of the front teeth to allow the back teeth to erupt.

Conditions

Overbite (Excessive) Deep

Keywords

Orthodontic Appliances; Dentition, Mixed

Outcome Measures

Primary Outcomes (6)

• Elimination of the moderate to severe anterior deep bite

  The success in overbite correction (yes/no) will be defined as the complete dissolution of deep bite, with an overbite 3mm.

  The success rate was assessed by comparing study models from before (T0) and after treatment (T1)(no more than 12 months).

• Measurement of overjet and overbite

  Measurement of overjet and overbite in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist.Obtained from digital bite models.

  Before (T0) and after treatment (T1) (no more than 12 months).

• Arch length to incised edge

  Measurement of the arch length to incisal edge, in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist. Obtained from digital bite models.

  Before (T0) and after treatment (T1) (no more than 12 months).

• Maxillary dental arch length total

  Measurement of the total maxillary dental arch length, in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist. Obtained from digital bite models.

  Before (T0) and after treatment (T1) (no more than 12 months).

• Transverse maxillary molar distance

  Measurement of the transverse maxillary molar distance, in millimeters, using a measured with a pencil and ruler. All measurements were made to the nearest 0.1 mm by an orthodontist. Obtained from digital bite models.

  Before (T0) and after treatment (T1) (no more than 12 months).

• Cephalometric analysis

  Cephalometric measures, including sagittal interdental, maxillary and mandibular dentoalveolar measurements, will be collected for each participant. All these measurements will be combined on a final evaluation of craniofacial changes. Conventional 2-D Lateral cephalograms will be taken from all patients before treatment (T0) and at the end of the active intervention (T1). A trained and calibrated orthodontist, previously calibrated will perform the measurements.

  Before (T0) and after treatment (T1) (no more than 12 months).

Secondary Outcomes (6)

• Treatment duration in months

  correction of deep bite up to a maximum of 12 months

• Breakages

  12 months

• Additional appointments

  12 months

• Emergency appointments

  12 months

• Compliance in the removable appliance group

  12 months

Study Arms (3)

No treatment of deep bite

NO INTERVENTION

No treatment of deep bite. These participants will be evaluated during a 6-month follow-up period. In cases were significant problems arise during the follow-up period, the participant will be removed from the study and the appropriate treatment conducted.

Fixed appliance

ACTIVE COMPARATOR

Fixed appliance: Treatment with a cemented modified palatal Nance appliance presenting a bite-plane.

Device: Fixed appliance

Composite bite plane

ACTIVE COMPARATOR

Composite bite plane: Treatment with a composite build up in the palatal aspect of the upper central incisors.

Procedure: Composite bite plane

Interventions

Fixed appliance DEVICE

Use of a cemented modified palatal Nance appliance presenting a bite-plane

Fixed appliance

Composite bite plane PROCEDURE

treatment with a composite build up in the palatal aspect of the upper central incisors.

Composite bite plane

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of moderate to severe deep bite (overbite, \>5.0 mm);
• fully erupted maxillary and mandibular incisors, as well as first permanent molars.

You may not qualify if:

• missing permanent incisors and molars;
• clinically noticeable craniofacial syndromes;
• need for immediate intervention to assess severe sagittal, transversal or vertical malocclusions.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Orthodontic clinic at the University of Alberta

Edmonton, Alberta, T6G 1C9, Canada

Location

Related Publications (12)

• Huang GJ, Bates SB, Ehlert AA, Whiting DP, Chen SS, Bollen AM. Stability of deep-bite correction: A systematic review. J World Fed Orthod. 2012 Sep 1;1(3):e89-e86. doi: 10.1016/j.ejwf.2012.09.001.

  PMID: 23630651 BACKGROUND

• Feldmann I, Lundstrom F, Peck S. Occlusal changes from adolescence to adulthood in untreated patients with Class II Division 1 deepbite malocclusion. Angle Orthod. 1999 Feb;69(1):33-8. doi: 10.1043/0003-3219(1999)0692.3.CO;2.

  PMID: 10022182 BACKGROUND

• de Souza BS, Bichara LM, Guerreiro JF, Quintao CC, Normando D. Occlusal and facial features in Amazon indigenous: An insight into the role of genetics and environment in the etiology dental malocclusion. Arch Oral Biol. 2015 Sep;60(9):1177-86. doi: 10.1016/j.archoralbio.2015.04.007. Epub 2015 May 21.

  PMID: 26051559 BACKGROUND

• Ferro R, Besostri A, Olivieri A, Stellini E. Prevalence of occlusal traits and orthodontic treatment need in 14 year-old adolescents in Northeast Italy. Eur J Paediatr Dent. 2016 Mar;17(1):36-42.

  PMID: 26949237 BACKGROUND

• Lux CJ, Ducker B, Pritsch M, Komposch G, Niekusch U. Occlusal status and prevalence of occlusal malocclusion traits among 9-year-old schoolchildren. Eur J Orthod. 2009 Jun;31(3):294-9. doi: 10.1093/ejo/cjn116. Epub 2009 Feb 25.

  PMID: 19244457 BACKGROUND

• Silness J, Roynstrand T. Effects of the degree of overbite and overjet on dental health. J Clin Periodontol. 1985 May;12(5):389-98. doi: 10.1111/j.1600-051x.1985.tb00929.x.

  PMID: 3859497 BACKGROUND

• Bergersen EO. A longitudinal study of anterior vertical overbite from eight to twenty years of age. Angle Orthod. 1988 Jul;58(3):237-56. doi: 10.1043/0003-3219(1988)0582.0.CO;2.

  PMID: 3189955 BACKGROUND

• Grippaudo C, Pantanali F, Paolantonio EG, Saulle R, Latorre G, Deli R. Orthodontic treatment timing in growing patients. Eur J Paediatr Dent. 2013 Sep;14(3):231-6.

  PMID: 24295010 BACKGROUND

• Baccetti T, Franchi L, Giuntini V, Masucci C, Vangelisti A, Defraia E. Early vs late orthodontic treatment of deepbite: a prospective clinical trial in growing subjects. Am J Orthod Dentofacial Orthop. 2012 Jul;142(1):75-82. doi: 10.1016/j.ajodo.2012.02.024.

  PMID: 22748993 BACKGROUND

• Hellsing E. Increased overbite and craniomandibular disorders--a clinical approach. Am J Orthod Dentofacial Orthop. 1990 Dec;98(6):516-22. doi: 10.1016/0889-5406(90)70018-8.

  PMID: 2248230 BACKGROUND

• Franchi L, Baccetti T, Giuntini V, Masucci C, Vangelisti A, Defraia E. Outcomes of two-phase orthodontic treatment of deepbite malocclusions. Angle Orthod. 2011 Nov;81(6):945-52. doi: 10.2319/033011-229.1. Epub 2011 Jul 29.

  PMID: 21801005 BACKGROUND

• Baccetti T, Franchi L, McNamara JA Jr. Longitudinal growth changes in subjects with deepbite. Am J Orthod Dentofacial Orthop. 2011 Aug;140(2):202-9. doi: 10.1016/j.ajodo.2011.04.015.

  PMID: 21803258 BACKGROUND

MeSH Terms

Conditions

Overbite

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Carlos Flores-Mir, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analyses will be blinded regarding treatment received and time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a stratified, parallel randomized controlled, single-blinded, with an allocation ratio of 1:1:1.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: January 15, 2019
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: May 23, 2022

Record last verified: 2019-10

Locations

CA (1)