Deep OverbiteNCT06430710
Tooth Borne Versus Temporary Anchorage Devices (TAD) Based Intrusion Systems for the Correction of Anterior Deep Overbite
A study testing Intrusion in people with Deep Overbite, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Overbite
- What is being tested?
- Intrusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2022to 27 Mar 2024
- 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 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class I or Class II malocclusion with minimal crowding.
- 70% to 100% overbite.
- High lip line with gingival display on smiling and super-eruption of maxillary incisors.
- All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less.
Who cannot join
- Having missing teeth on the anterior maxillary area.
- Any history of trauma or root canal treatment.
- Previous orthodontic treatment.
- Low lip line duing social smile.
- Having any hormonal disorder or syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tooth Borne Versus Temporary Anchorage Devices Based Intrusion Systems for the Correction of Anterior Deep Overbite;Oral Hygiene, Pain and Treatment Effect
Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite
Read the detailed description
this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) [miniscrew] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period.
- Conditions
- Deep Overbite
- Being tested
- Intrusion
- Keywords
- Anterior deep bite, Intrusive arch, Miniscrews
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntrusionDevice
2 different methods for incisor intrusion
| Study group | Role | What they receive |
|---|---|---|
| Mninscrew | Experimental | Miniscrews for incisor intrusion Receives: Device: Intrusion |
| Intrusive arch | Experimental | Continuous arch technique for incisor intrusion Receives: Device: Intrusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure distance of insicors intrusion
measure in mm the distance of apical movement
Measured: 2 years
Secondary outcomes (1)
Pain intensity
By unit on Visual Analogue Scale
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start25 Sep 2022
- Primary completion2 Feb 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep 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
- Model description
- Sixteen patients with anterior deep over bite participated in two groups each group contains eight patients
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430710
- Sponsor's protocol ID
- ORTHO-109-2H
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Borne Versus Temporary Anchorage Devices Based Intrusion Systems for the Correction of Anterior Deep Overbite;Oral Hygiene, Pain and Treatment Effect
- ClinicalTrials.gov ID
- NCT06430710
- Acronym / sponsor ID
- ORTHO-109-2H
- Conditions
- Deep Overbite
- Keywords
- Anterior deep bite, Intrusive arch, Miniscrews
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 25 Sep 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 28 May 2024 (actual)
- 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.
Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite
Detailed description
this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) [miniscrew] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixteen patients with anterior deep over bite participated in two groups each group contains eight patients
| Arm | Type | Receives |
|---|---|---|
| Mninscrew | Experimental | Device: IntrusionMiniscrews for incisor intrusion |
| Intrusive arch | Experimental | Device: IntrusionContinuous arch technique for incisor intrusion |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Class I or Class II malocclusion with minimal crowding.
- 70% to 100% overbite.
- High lip line with gingival display on smiling and super-eruption of maxillary incisors.
- All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less.
Key exclusion criteria (5 listed)
- Having missing teeth on the anterior maxillary area.
- Any history of trauma or root canal treatment.
- Previous orthodontic treatment.
- Low lip line duing social smile.
- Having any hormonal disorder or 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 |
|---|---|---|
| Intrusion2 different methods for incisor intrusion | Device | Intrusive arch, Mninscrew |
Primary outcome
Measure distance of insicors intrusion
Time frame: 2 years
measure in mm the distance of apical movement
1 secondary outcome
Pain intensity
Time frame: 8 months
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 28 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrusion in people with Deep Overbite, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
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 5 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 28 May 2024. 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 Egypt. 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?
Measure distance of insicors intrusion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2024.