Volumetric Root ResorptionNCT06704165
Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket
A study testing Orthodontic treatment using double slot bracket wire in high level slot and Orthodontic treatment using double slot bracket with wire in low level slot in people with Volumetric Root Resorption, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Evaluate the possible apical root resorption during deep bite correction by double slot bracket with low level slot versus high level slot using CBCT. Read more about this study
- Who is it for?
- Ages 18 to 23 years, women only
- Conditions the study is for
- Volumetric Root Resorption
- What is being tested?
- Orthodontic treatment using double slot bracket wire in high level slot and Orthodontic treatment using double slot bracket with wire in low level slot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 1 Oct 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 18 to 23 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients to avoid any sexual dimorphism which may affect the comparison.
- Age range from 18 to 23year.
- Patients with anterior dento alveolar deep bite.
- Angle class I or class II malocclusion with minimal crowding.
- Healthy compliant and motivated patient.
- No missing of any tooth except wisdom teeth
Who cannot join
- 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Prosthetic replacement in lower anterior teeth. 5. periodontitis with pocket depth more than 5 mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket; a Clinical Trial Study
Evaluate the possible apical root resorption during deep bite correction by double slot bracket with low level slot versus high level slot using CBCT.
Read the detailed description
Group (A): Patients will be treated with double slot brackets using low level slot in deep bite correction. Group (B): Patients will be treated with double slot brackets using high level slot in deep bite correction.
- Conditions
- Volumetric Root Resorption
- Being tested
- Orthodontic treatment using double slot bracket wire in high level slot, Orthodontic treatment using double slot bracket with wire in low level slot
- Keywords
- intrusion,root resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic treatment using double slot bracket wire in high level slotProcedure or surgery
patients will receives the new treatment therapy by using Double slot bracket with the wire in low level for the treatment of anterior deep bite .
Orthodontic treatment using double slot bracket with wire in low level slotProcedure or surgery
patients will receives the new treatment therapy by using Double slot bracket with the wire in high level for the treatment of anterior deep bite .
| Study group | Role | What they receive |
|---|---|---|
| Evaluate the possible apical root resorption by double slot bracket withwire in high level slot. | Experimental | Control group : patients will receive a conventional therapy with Double slot bracket with the wire in high level for the treatment of anterior deep bite . Receives: Procedure: Orthodontic treatment using double slot bracket wire in high level slot |
| Evaluate the possible apical root resorption by double slot bracket with wire in low level slot. | Experimental | investigational group will receives the new treatment therapy by using Double slot bracket with the wire in low level for the treatment of anterior deep bite . Receives: Procedure: Orthodontic treatment using double slot bracket with wire in low level slot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Evaluate and compare the amount of volumetric root resorption. CBCT used in volumetric image.
Measured: "through study completion, an average of 1 year".
Secondary outcomes (1)
Secondary Outcome Measure
Evaluation of alveolar bone changes using CBCT.
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Jun 2022
- Primary completion5 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volumetric Root ResorptionStudies 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
- Crossover
- 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
- Principal investigator, Alaa Abd Elsalam Ramadan Salama, Faculty of Dental Medicine for Girls
- Investigators
- Samir Abdo Ibrahim, professor, Principal investigator, AL Azher university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704165
- Sponsor's protocol ID
- P-OR-22-02
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket; a Clinical Trial Study
- ClinicalTrials.gov ID
- NCT06704165
- Acronym / sponsor ID
- P-OR-22-02
- Conditions
- Volumetric Root Resorption
- Keywords
- intrusion,root resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 26 Nov 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.
Evaluate the possible apical root resorption during deep bite correction by double slot bracket with low level slot versus high level slot using CBCT.
Detailed description
Group (A): Patients will be treated with double slot brackets using low level slot in deep bite correction. Group (B): Patients will be treated with double slot brackets using high level slot in deep bite correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluate the possible apical root resorption by double slot bracket withwire in high level slot. | Experimental | Procedure: Orthodontic treatment using double slot bracket wire in high level slotControl group : patients will receive a conventional therapy with Double slot bracket with the wire in high level for the treatment of anterior deep bite . |
| Evaluate the possible apical root resorption by double slot bracket with wire in low level slot. | Experimental | Procedure: Orthodontic treatment using double slot bracket with wire in low level slotinvestigational group will receives the new treatment therapy by using Double slot bracket with the wire in low level for the treatment of anterior deep bite . |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients to avoid any sexual dimorphism which may affect the comparison.
- Age range from 18 to 23year.
- Patients with anterior dento alveolar deep bite.
- Angle class I or class II malocclusion with minimal crowding.
- Healthy compliant and motivated patient.
Key exclusion criteria (1 listed)
- 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Prosthetic replacement in lower anterior teeth. 5. periodontitis with pocket depth more than 5 mm
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 |
|---|---|---|
| Orthodontic treatment using double slot bracket wire in high level slotpatients will receives the new treatment therapy by using Double slot bracket with the wire in low level for the treatment of anterior deep bite . | Procedure or surgery | Evaluate the possible apical root resorption by double slot bracket withwire in high level slot. |
| Orthodontic treatment using double slot bracket with wire in low level slotpatients will receives the new treatment therapy by using Double slot bracket with the wire in high level for the treatment of anterior deep bite . | Procedure or surgery | Evaluate the possible apical root resorption by double slot bracket with wire in low level slot. |
Primary outcome
Primary Outcome Measure
Time frame: "through study completion, an average of 1 year".
Evaluate and compare the amount of volumetric root resorption. CBCT used in volumetric image.
1 secondary outcome
Secondary Outcome Measure
Time frame: "through study completion, an average of 1 year".
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 26 Nov 2024.
- Individual participant dataSharing planned: No
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.
Samir Abdo Ibrahim, professor principal investigator
AL Azher university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic treatment using double slot bracket wire in high level slot and Orthodontic treatment using double slot bracket with wire in low level slot in people with Volumetric Root Resorption, 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 6 inclusion and 1 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 26 Nov 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?
Primary Outcome Measure (time frame: "through study completion, an average of 1 year".). 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 26 Nov 2024.