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Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation

Primary Purpose

Increased Overbite

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bite turbo
Sponsored by
NHS Tayside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Increased Overbite focused on measuring orthodontics

Eligibility Criteria

9 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Class II division 2 malocclusion
  • No history of active orthodontic treatment
  • Increased overbite (greater than one third lower incisal coverage)
  • Age 9-16

Exclusion Criteria:

  • Restorations on the palatal surface of the maxillary incisors
  • Increased overjet where the lower incisor edge occludes distal to the cingulum of the upper incisor
  • Profound hypodontia (>1 missing tooth per quadrant)
  • Subjects beyond pubertal growth stage
  • Suspected or identifiable syndromes
  • Subjects with cleft lip and palate
  • Growth anomalies or taking growth accelerating/ inhibiting medication

Sites / Locations

  • Dundee Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

A standard initial lateral cephalogram radiograph will be taken of all subjects, unless this is already available within the specified age range. An intra-oral scanner will be used to accurately record the occlusal relationships prior to insertion of the fixed anterior bite plane (bite turbos) (T0) and repeated immediately after placement (T1). Each subject will then be re-scanned on a six weekly basis for a period of six months (T2-T5). Conventional clinical photographs and three-dimensional stereophotogrammetry will be used to assess the vertical facial relationships at T0-T5. A further lateral cephalogram radiograph will be taken at T5.

A control group of subjects from the treatment waiting list who meet the inclusion criteria will be used. An intra-oral scanner will record the baseline occlusal relationship (T0) and will be repeated after six months (T5). The control group will also have a standard pre-treatment lateral cephalogram radiograph taken, as well as conventional and three-dimensional stereophotogrammetry at baseline (T0) and after six months (T5). This will allow changes resulting from growth to be assessed whilst no active orthodontic treatment has taken place.

Outcomes

Primary Outcome Measures

The rate of occlusal reestablishment (measured as first molar contact) following insertion of fixed anterior bite planes (measured in weeks)
An intra-oral scanner will allow detailed analysis of the occlusal changes following insertion of fixed anterior bite planes. Participants will be re-scanned every 6 weeks for a period of 6 months to determine if and when first molar contact is re-established.

Secondary Outcome Measures

The acceptability of fixed anterior bite planes and intra-oral scanning in adolescents (questionnaire)
A questionnaire will be used in the intervention group after 6 months to determine the acceptability of the fixed bite planes
If treatment with bite planes increases participants knowledge of overbite reduction and relation to oral health/ orthodontic treatment (questionnaire)
Questionnaires will be used at T0 and T5 (in the intervention group) to assess participants knowledge of overbite reduction and its impact on dental health.
Economic impact of using fixed bite planes as an alternative to a removable appliance (measured in pounds sterling)
An estimate will be made of the cost of providing the fixed bite planes compared to the standard method of overbite reduction using a removable appliance
The nature of occlusal changes following insertion of fixed anterior bite planes
An intra-oral scanner will allow detailed analysis of what occlusal changes occur (eruption/intrusion) following insertion of fixed anterior bite planes

Full Information

First Posted
September 22, 2016
Last Updated
August 3, 2020
Sponsor
NHS Tayside
Collaborators
University of Dundee
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1. Study Identification

Unique Protocol Identification Number
NCT02925468
Brief Title
Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation
Official Title
Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Tayside
Collaborators
University of Dundee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The correction of a deep overbite is assumed to involve incisor intrusion and the extrusion or eruption of premolars and molars. The latter is also assumed to be the major contributor for growing patients where the vertical facial growth increase accommodates for the additional eruption of posterior teeth with anterior bite plane appliances. In this study the nature and rate of adaptation of the occlusal changes following insertion of a fixed anterior bite plane for the reduction of a deep overbite in growing patients will be investigated.
Detailed Description
All subjects who meet the inclusion criteria will be informed of the study and written consent sought for their participation. Subjects will be recruited from the new patient clinics and routine treatment waiting list. A standard initial lateral cephalogram will be taken of all subjects, unless this is already available within the specified age range. Active growth will be determined using the Bacetti CVM method. For the Intervention group - an intra-oral scanner will be used to accurately record the occlusal relationships prior to insertion of the fixed anterior bite plane (T0) and repeated immediately after placement (T1). Each subject will then be re-scanned on a six weekly basis for a period of six months (T2-T5). Conventional clinical photographs and three-dimensional stereophotogrammetry will be used to assess the vertical facial relationships at T0-T5. A further lateral cephalogram will be taken at T5 to assess for skeletal change and assess for evidence of intrusion and eruption as well as determine if there has been an alteration in incisor inclination. A control group of subjects from the treatment waiting list who meet the inclusion criteria will be used. An intra-oral scanner will record the baseline occlusal relationship (T0) and will be repeated after six months (T5). The control group will also have a standard pre-treatment lateral cephalogram taken, as well as conventional and three-dimensional stereophotogrammetry at baseline (T0) and after six months (T5). This will allow changes resulting from growth to be assessed whilst no active orthodontic treatment has taken place. The primary outcomes to be assessed will be the nature of the change in occlusal-vertical dimension and the rate of occlusal adaptation in relation to facial growth changes. The intra-oral scans and photographs will be analysed using three-dimensional technology to determine the immediate change and any resultant occlusal adaptation and change in lower face height on a six weekly basis for six months. All subjects and guardians in the intervention group will be asked to complete a short questionnaire immediately after visits T1 and T5. This will assess their experience of the 3-D scanning and bite planes (if applicable). We will also assess their knowledge of overbite definition, process of overbite reduction and effects of an increased overbite on oral health. The control group will be asked to complete the same questionnaire at T0. The economic impact of managing the increased overbite as an initial phase of treatment versus single phase comprehensive treatment will be investigated. A cost analysis will be performed to investigate any economic difference in using bite turbos versus a removable appliance to reduce the overbite.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Increased Overbite
Keywords
orthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
A standard initial lateral cephalogram radiograph will be taken of all subjects, unless this is already available within the specified age range. An intra-oral scanner will be used to accurately record the occlusal relationships prior to insertion of the fixed anterior bite plane (bite turbos) (T0) and repeated immediately after placement (T1). Each subject will then be re-scanned on a six weekly basis for a period of six months (T2-T5). Conventional clinical photographs and three-dimensional stereophotogrammetry will be used to assess the vertical facial relationships at T0-T5. A further lateral cephalogram radiograph will be taken at T5.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
A control group of subjects from the treatment waiting list who meet the inclusion criteria will be used. An intra-oral scanner will record the baseline occlusal relationship (T0) and will be repeated after six months (T5). The control group will also have a standard pre-treatment lateral cephalogram radiograph taken, as well as conventional and three-dimensional stereophotogrammetry at baseline (T0) and after six months (T5). This will allow changes resulting from growth to be assessed whilst no active orthodontic treatment has taken place.
Intervention Type
Device
Intervention Name(s)
Bite turbo
Other Intervention Name(s)
Ormco Europe 350-0000
Intervention Description
In this study the nature and speed of adaptation of the occlusal changes following insertion of an anterior bite plane (bite turbos) for the reduction of a deep overbite in growing patients will be investigated.
Primary Outcome Measure Information:
Title
The rate of occlusal reestablishment (measured as first molar contact) following insertion of fixed anterior bite planes (measured in weeks)
Description
An intra-oral scanner will allow detailed analysis of the occlusal changes following insertion of fixed anterior bite planes. Participants will be re-scanned every 6 weeks for a period of 6 months to determine if and when first molar contact is re-established.
Time Frame
Measured 6-weekly for a period of 6 months (T0-T5)
Secondary Outcome Measure Information:
Title
The acceptability of fixed anterior bite planes and intra-oral scanning in adolescents (questionnaire)
Description
A questionnaire will be used in the intervention group after 6 months to determine the acceptability of the fixed bite planes
Time Frame
6 months
Title
If treatment with bite planes increases participants knowledge of overbite reduction and relation to oral health/ orthodontic treatment (questionnaire)
Description
Questionnaires will be used at T0 and T5 (in the intervention group) to assess participants knowledge of overbite reduction and its impact on dental health.
Time Frame
6 months
Title
Economic impact of using fixed bite planes as an alternative to a removable appliance (measured in pounds sterling)
Description
An estimate will be made of the cost of providing the fixed bite planes compared to the standard method of overbite reduction using a removable appliance
Time Frame
6 months
Title
The nature of occlusal changes following insertion of fixed anterior bite planes
Description
An intra-oral scanner will allow detailed analysis of what occlusal changes occur (eruption/intrusion) following insertion of fixed anterior bite planes
Time Frame
Measured 6-weekly for a period of 6 months (T0-T5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Class II division 2 malocclusion No history of active orthodontic treatment Increased overbite (greater than one third lower incisal coverage) Age 9-16 Exclusion Criteria: Restorations on the palatal surface of the maxillary incisors Increased overjet where the lower incisor edge occludes distal to the cingulum of the upper incisor Profound hypodontia (>1 missing tooth per quadrant) Subjects beyond pubertal growth stage Suspected or identifiable syndromes Subjects with cleft lip and palate Growth anomalies or taking growth accelerating/ inhibiting medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant McIntyre
Organizational Affiliation
NHS Tayside
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dundee Dental Hospital
City
Dundee
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation

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