Accerleration of Tooth MovementNCT05595174
Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations
A study testing self ligating bracket with micro osteoperforation, conventional bracket with micro osteoperforation and conventional bracket without micro osteoperforation in people with Accerleration of Tooth Movement, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Assessment of maxillary canine retraction using self-ligating brackets system assisted with micro-osteoperforations: A prospective controlled clinical study Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Accerleration of Tooth Movement
- What is being tested?
- self ligating bracket with micro osteoperforation, conventional bracket with micro osteoperforation and conventional bracket without micro osteoperforation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 15 Aug 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both male and female patients between the age (14-20 y).
- Patients indicated for maxillary first premolar extraction.
- Angle's Class I bimaxillary, Class II Division 1 malocclusion (ANB <5).
- Irregularity index < 4 mm.
- No previous orthodontic treatment.
- Fully erupted dentition.
Who cannot join
- Patients not indicated for non-extraction approach.
- Prominent canine root (in labial cortical bone).
- History of systemic and medical illness that could interfere with OTM.
- Previous orthodontic treatment.
- Extreme skeletal class II occlusion (ANB >5).
- Poor oral hygiene or periodontally compromised patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations: A Prospective Controlled Clinical Study
Assessment of maxillary canine retraction using self-ligating brackets system assisted with micro-osteoperforations: A prospective controlled clinical study
- Conditions
- Accerleration of Tooth Movement
- Being tested
- self ligating bracket with micro osteoperforation, conventional bracket with micro osteoperforation, conventional bracket without micro osteoperforation, self ligating bracket without micro osteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self ligating bracket with micro osteoperforationBiological
A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Micro-osteoperforations will be formed
conventional bracket with micro osteoperforationBiological
A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Micro-osteoperforations will be formed.
conventional bracket without micro osteoperforationBiological
A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel titanium were followed to achieve leveling and alignment
self ligating bracket without micro osteoperforationBiological
A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Patient with self-ligating bracket system split mouth with and without micro-osteoperforations.
Extraction of first premolars were done. A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Receives: Biological: self ligating bracket with micro osteoperforation; Biological: self ligating bracket without micro osteoperforation |
| group 2 | Active comparator | Patient with conventional bracket with split mouth with and without micro-osteoperforations.
Extraction of first premolars were done. A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Receives: Biological: conventional bracket with micro osteoperforation; Biological: conventional bracket without micro osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of canine retraction
assessment of maxillary canine retraction rate using self-ligating brackets system assisted with micro-osteoperforations.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
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 Accerleration of Tooth MovementStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Sobhy Abdelaziz, Al-Azhar University
- Investigators
- khaled sobhy abdelaziz, master, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595174
- Sponsor's protocol ID
- 850/2057
- Status last verified
- Jan 2024
- First submitted
- 23 Oct 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abbing A, Koretsi V, Eliades T, Papageorgiou SN. Duration of orthodontic treatment with fixed appliances in adolescents and adults: a systematic review with meta-analysis. Prog Orthod. 2020 Oct 5;21(1):37. doi: 10.1186/s40510-020-00334-4.
PubMed 33015719
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations: A Prospective Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05595174
- Acronym / sponsor ID
- 850/2057
- Conditions
- Accerleration of Tooth Movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 26 Oct 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.
Assessment of maxillary canine retraction using self-ligating brackets system assisted with micro-osteoperforations: A prospective controlled clinical study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Biological: self ligating bracket with micro osteoperforation, Biological: self ligating bracket without micro osteoperforationPatient with self-ligating bracket system split mouth with and without micro-osteoperforations. Extraction of first premolars were done. A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. |
| group 2 | Active comparator | Biological: conventional bracket with micro osteoperforation, Biological: conventional bracket without micro osteoperforationPatient with conventional bracket with split mouth with and without micro-osteoperforations. Extraction of first premolars were done. A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Both male and female patients between the age (14-20 y).
- Patients indicated for maxillary first premolar extraction.
- Angle's Class I bimaxillary, Class II Division 1 malocclusion (ANB <5).
- Irregularity index < 4 mm.
- No previous orthodontic treatment.
Key exclusion criteria (6 listed)
- Patients not indicated for non-extraction approach.
- Prominent canine root (in labial cortical bone).
- History of systemic and medical illness that could interfere with OTM.
- Previous orthodontic treatment.
- Extreme skeletal class II occlusion (ANB >5).
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 |
|---|---|---|
| self ligating bracket with micro osteoperforationA standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Micro-osteoperforations will be formed | Biological | group 1 |
| conventional bracket with micro osteoperforationA standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Micro-osteoperforations will be formed. | Biological | group 2 |
| conventional bracket without micro osteoperforationA standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel titanium were followed to achieve leveling and alignment | Biological | group 2 |
| self ligating bracket without micro osteoperforationA standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. | Biological | group 1 |
Primary outcome
effect of canine retraction
Time frame: at 6 months
assessment of maxillary canine retraction rate using self-ligating brackets system assisted with micro-osteoperforations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 33015719Abbing A, Koretsi V, Eliades T, Papageorgiou SN. Duration of orthodontic treatment with fixed appliances in adolescents and adults: a systematic review with meta-analysis. Prog Orthod. 2020 Oct 5;21(1):37. doi: 10.1186/s40510-020-00334-4.
- Individual participant dataSharing planned: Yes
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.
khaled sobhy abdelaziz, master principal investigator
Al-Azhar 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 self ligating bracket with micro osteoperforation, conventional bracket with micro osteoperforation and conventional bracket without micro osteoperforation in people with Accerleration of Tooth Movement, run by Al-Azhar 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jan 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?
Results are not available in the source record.
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?
effect of canine retraction (time frame: at 6 months). 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 NCT05595174, 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 3 Jan 2024.