Deep OverbiteNCT05654558
Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
A study testing Auxiliary cantilever intrusion arches on initial archwires and Routine leveling and alignment in people with Deep Overbite, run by Alexandria University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Deep Overbite
- What is being tested?
- Auxiliary cantilever intrusion arches on initial archwires and Routine leveling and alignment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2020to 30 Jun 2022
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Permanent dentition present except for third molars
- No history of previous orthodontic treatment.
- Class I or II malocclusion with minimal or no lower anterior crowding (<3 mm)
- Excessive overbite (>3 mm).
Who cannot join
- Syndromic patients as well as individuals with skeletal asymmetry
- Endodontically treated or periodontally involved loweranterior teeth.
- Need for tooth extraction in the lower arch.
- Agenesis (except for third molars)
- Any kind of tooth/root shape anomaly
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors.
- Conditions
- Deep Overbite
- Being tested
- Auxiliary cantilever intrusion arches on initial archwires, Routine leveling and alignment
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auxiliary cantilever intrusion arches on initial archwiresDevice
Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment.
Routine leveling and alignmentDevice
Also called Relative Intrusion
Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Auxiliary intrusion cantilevers | Experimental | Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment. Receives: Device: Auxiliary cantilever intrusion arches on initial archwires |
| Routine leveling and alignment | Active comparator | Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment. Receives: Device: Routine leveling and alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overbite
Distance between incisal edges of upper and lower incisors measured on lateral cephalometric x-rays
Measured: six months
True incisor intrusion
Perpendicular distance between the center of resistance of mandibular central incisor and the mandibular plane measured on lateral cephalometric x-rays
Measured: six months
Proclination of lower incisors
Angle formed by the long axis of mandibular central incisor and mandibular plane measured on lateral cephalometric x-rays
Measured: six months
Lower incisor intrusion and proclination
Perpendicular distance between the incisal edge of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays
Measured: six months
Lower incisor intrusion
Perpendicular distance between the apex of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays
Measured: six months
Extrusion of lower first molar
Perpendicular distance between the mesio-buccal cusp tip of the lower first molar and mandibular plane measured on lateral cephalometric x-rays
Measured: six months
Distal tip of lower first molar
Angle formed between the long axis of lower 1st molar and mandibular plane measured on lateral cephalometric x-rays
Measured: six months
Secondary outcomes (4)
Depth of curve of Spee
Measured on dental casts by summing the right and left side maximum depths from a flat plane formed by the tips of the mandibular incisors anteriorly and the distal cusp tips of the second molars posteriorly
Measured: six months
Depth of gingival sulcus
The sulcus depth was measured using Michigan O periodontal probe.
Measured: six months
Width of keratinized gingiva
Measured with the aid of periodontal probe from the free gingival margin to the mucogingival junction.
Measured: six months
Root resorption of lower incisors
Length of lower incisor roots was compared in before- and after-periapical radiographs taken with a paralleling technique.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start12 Sep 2020
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
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
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona El-Maghraby, Alexandria University
- Investigators
- Mona Elmaghraby, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptHanan Ismail, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptHassan Kassem, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654558
- Sponsor's protocol ID
- 0049-08/2019
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
- ClinicalTrials.gov ID
- NCT05654558
- Acronym / sponsor ID
- 0049-08/2019
- Conditions
- Deep Overbite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Dec 2022 (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.
The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auxiliary intrusion cantilevers | Experimental | Device: Auxiliary cantilever intrusion arches on initial archwiresPatients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment. |
| Routine leveling and alignment | Active comparator | Device: Routine leveling and alignmentPatients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Permanent dentition present except for third molars
- No history of previous orthodontic treatment.
- Class I or II malocclusion with minimal or no lower anterior crowding (<3 mm)
- Excessive overbite (>3 mm).
Key exclusion criteria (5 listed)
- Syndromic patients as well as individuals with skeletal asymmetry
- Endodontically treated or periodontally involved loweranterior teeth.
- Need for tooth extraction in the lower arch.
- Agenesis (except for third molars)
- Any kind of tooth/root shape anomaly
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 |
|---|---|---|
| Auxiliary cantilever intrusion arches on initial archwiresPatients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment. | Device | Auxiliary intrusion cantilevers |
| Routine leveling and alignmentAlso: Relative IntrusionPatients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment. | Device | Routine leveling and alignment |
Primary outcome
Overbite
Time frame: six months
Distance between incisal edges of upper and lower incisors measured on lateral cephalometric x-rays
True incisor intrusion
Time frame: six months
Perpendicular distance between the center of resistance of mandibular central incisor and the mandibular plane measured on lateral cephalometric x-rays
Proclination of lower incisors
Time frame: six months
Angle formed by the long axis of mandibular central incisor and mandibular plane measured on lateral cephalometric x-rays
Lower incisor intrusion and proclination
Time frame: six months
Perpendicular distance between the incisal edge of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays
Lower incisor intrusion
Time frame: six months
Perpendicular distance between the apex of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays
Extrusion of lower first molar
Time frame: six months
Perpendicular distance between the mesio-buccal cusp tip of the lower first molar and mandibular plane measured on lateral cephalometric x-rays
Distal tip of lower first molar
Time frame: six months
Angle formed between the long axis of lower 1st molar and mandibular plane measured on lateral cephalometric x-rays
4 secondary outcomes
Depth of curve of Spee
Time frame: six months
Depth of gingival sulcus
Time frame: six months
Width of keratinized gingiva
Time frame: six months
Root resorption of lower incisors
Time frame: six 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 16 Dec 2022.
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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.
Mona Elmaghraby, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Hanan Ismail, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Hassan Kassem, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auxiliary cantilever intrusion arches on initial archwires and Routine leveling and alignment in people with Deep Overbite, run by Alexandria University 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 16 Dec 2022. 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?
Overbite (time frame: six months). The study lists 7 primary outcomes in all. 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 16 Dec 2022.