Increased OverbiteNCT02925468
Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation
A study testing Bite turbo in people with Increased Overbite, run by NHS Tayside at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Increased Overbite
- What is being tested?
- Bite turbo
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Feb 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 9 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Class II division 2 malocclusion
- No history of active orthodontic treatment
- Increased overbite (greater than one third lower incisal coverage)
- Age 9-16
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Increased Overbite
- Being tested
- Bite turbo
- Keywords
- orthodontics
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bite turboDevice
Also called Ormco Europe 350-0000
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Bite turbo |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured 6-weekly for a period of 6 months (T0-T5)
Secondary outcomes (4)
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
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
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
Measured: Measured 6-weekly for a period of 6 months (T0-T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Increased OverbiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Collaborators
- University of Dundee
- Responsible party
- Principal investigator, Evelyn Dunbar, NHS Tayside
- Investigators
- Grant McIntyre, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925468
- Sponsor's protocol ID
- 2016DE02
- Status last verified
- Aug 2020
- First submitted
- 22 Sep 2016
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Dunbar E, Chalmers E, Sivamurthy G, Revie G, McIntyre GT, Mossey PA. Is occlusal contact re-established within 6 months after bonding of a fixed anterior bite plane in adolescents with a Class II division 2 incisor relationship? A randomised controlled trial. J Orthod. 2025 Jun;52(2):115-132. doi: 10.1177/14653125241277832. Epub 2024 Sep 30.
PubMed 39345006
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthodontic Reduction of an Increased Overbite in Adolescents - the Mechanism and Rate of Occlusal Adaptation
- ClinicalTrials.gov ID
- NCT02925468
- Acronym / sponsor ID
- 2016DE02
- Conditions
- Increased Overbite
- Keywords
- orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Collaborators
- University of Dundee
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Bite turboA 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Class II division 2 malocclusion
- No history of active orthodontic treatment
- Increased overbite (greater than one third lower incisal coverage)
- Age 9-16
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bite turboAlso: Ormco Europe 350-0000In 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. | Device | Intervention group |
Primary outcome
The rate of occlusal reestablishment (measured as first molar contact) following insertion of fixed anterior bite planes (measured in weeks)
Time frame: Measured 6-weekly for a period of 6 months (T0-T5)
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.
4 secondary outcomes
The acceptability of fixed anterior bite planes and intra-oral scanning in adolescents (questionnaire)
Time frame: 6 months
If treatment with bite planes increases participants knowledge of overbite reduction and relation to oral health/ orthodontic treatment (questionnaire)
Time frame: 6 months
Economic impact of using fixed bite planes as an alternative to a removable appliance (measured in pounds sterling)
Time frame: 6 months
The nature of occlusal changes following insertion of fixed anterior bite planes
Time frame: Measured 6-weekly for a period of 6 months (T0-T5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Derived from this study: PubMed 39345006Dunbar E, Chalmers E, Sivamurthy G, Revie G, McIntyre GT, Mossey PA. Is occlusal contact re-established within 6 months after bonding of a fixed anterior bite plane in adolescents with a Class II division 2 incisor relationship? A randomised controlled trial. J Orthod. 2025 Jun;52(2):115-132. doi: 10.1177/14653125241277832. Epub 2024 Sep 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant McIntyre principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bite turbo in people with Increased Overbite, run by NHS Tayside at 1 site in United Kingdom.
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 4 inclusion and 7 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 5 Aug 2020. 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 United Kingdom. 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?
The rate of occlusal reestablishment (measured as first molar contact) following insertion of fixed anterior bite planes (measured in weeks) (time frame: Measured 6-weekly for a period of 6 months (T0-T5)). 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 NCT02925468, which also lists 1 linked publication.
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 5 Aug 2020.