Orthodontic Appliance ComplicationNCT06416904
Evaluation Of Anchorage Control Using Arch Wire Stopper Versus Mini-Screws
A study testing archwire stopper mesial to the maxillary first molar group and inter-radicular mini-screw in people with Orthodontic Appliance Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to compare the anchorage control using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- archwire stopper mesial to the maxillary first molar group and inter-radicular mini-screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Feb 2024to 1 Dec 2025
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-pubertal female patients.
- Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
- Full permanent dentition (not necessitating third molars).
- Good oral hygiene.
Who cannot join
- Medically compromised patients.
- Active periodontal disease or obvious bone loss in the maxillary arch.
- Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
- Smoking or any systemic diseases.
- Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
- Previous orthodontic treatment.
- Missing teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Anchorage Control Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial
The study aims to compare the anchorage control using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion
Read the detailed description
The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.
After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.
- In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.
Afterwards, anterior segment retraction will be done using T-loop on 0.017x0.025 TMA archwire
- In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws Afterwards, anterior segment retraction will be done using T-loop on 0.017x0.025 TMA archwire
Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- archwire stopper mesial to the maxillary first molar group, inter-radicular mini-screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
archwire stopper mesial to the maxillary first molar groupDevice
canine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars.
inter-radicular mini-screwDevice
canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw.
| Study group | Role | What they receive |
|---|---|---|
| arch wire stopper mesial to the maxillary first molar group | Experimental | In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars followed by anterior segment retraction using T-loop on 0.017x0.025 TMA arch wire. Receives: Device: archwire stopper mesial to the maxillary first molar group |
| maxillary first molar indirectly anchored to the inter-radicular mini-screw group | Active comparator | In postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw followed by anterior segment retraction using T-loop on 0.017x0.025 TMA arch wire. Receives: Device: inter-radicular mini-screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of anchorage loss of the maxillary first molars
After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models
Measured: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
Secondary outcomes (3)
Tipping of the maxillary first molar.
the degree of tipping of the maxillary first molars will be assessed on the lateral cephalometric radiograph
Measured: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
Maxillary incisors inclination
The change in the maxillary incisors inclination will be assessed on the lateral cephalometric radiograph
Measured: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
Maxillary incisors anteroposterior position
The change in the maxillary incisors anteroposterior position will be assessed on the lateral cephalometric radiograph and digital models
Measured: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start13 Feb 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menahtallah Moamen Mohamed Mohamed Ali, Cairo University
- Investigators
- Mennatallah Ali, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416904
- Sponsor's protocol ID
- ORTH3-3-3
- Status last verified
- Oct 2026
- First submitted
- 12 May 2024
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Anchorage Control Using Arch Wire Stopper in Comparison to Mini-Screws in Post-Pubertal Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06416904
- Acronym / sponsor ID
- ORTH3-3-3
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 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.
The study aims to compare the anchorage control using arch wire stopper versus mini-screws in post-pubertal patients with maxillary dentoalveolar protrusion
Detailed description
The study begins with patient selection according to inclusion and exclusion criteria, followed by treatment planning, and then bonding of orthodontic brackets of the upper and lower arches, including the second maxillary molars.
After leveling and alignment for all participants, the extraction of the maxillary first premolars will be performed.
- In the "Intervention Group" Canine retraction will be performed on 0.017×0.025 ss archwire with an archwire stopper mesial to the upper first molar.
Afterwards, anterior segment retraction will be done using T-loop on 0.017x0.025 TMA archwire
- In the "Comparator Group" Canine retraction on 0.017×0.025 ss archwire with the upper first molars indirectly anchored to inter-radicular mini screws Afterwards, anterior segment retraction will be done using T-loop on 0.017x0.025 TMA archwire
Lastly, the anchorage control in both groups and the secondary outcomes will be assessed using the obtained digital models and lateral cephalometric radiographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arch wire stopper mesial to the maxillary first molar group | Experimental | Device: archwire stopper mesial to the maxillary first molar groupIn postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars with archwire stoppers mesial to the maxillary first molars followed by anterior segment retraction using T-loop on 0.017x0.025 TMA arch wire. |
| maxillary first molar indirectly anchored to the inter-radicular mini-screw group | Active comparator | Device: inter-radicular mini-screwIn postpubertal female patients with maxillary dentoalveolar protrusion, canine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw followed by anterior segment retraction using T-loop on 0.017x0.025 TMA arch wire. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Post-pubertal female patients.
- Cases with bimaxillary protrusion or Class II Division 1 malocclusion that require maxillary first premolars extraction.
- Full permanent dentition (not necessitating third molars).
- Good oral hygiene.
Key exclusion criteria (7 listed)
- Medically compromised patients.
- Active periodontal disease or obvious bone loss in the maxillary arch.
- Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
- Smoking or any systemic diseases.
- Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement
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 |
|---|---|---|
| archwire stopper mesial to the maxillary first molar groupcanine retraction after the extraction of the maxillary first premolars with archwire stoppers is mesial to the maxillary first molars. | Device | arch wire stopper mesial to the maxillary first molar group |
| inter-radicular mini-screwcanine retraction after the extraction of the maxillary first premolars, with the maxillary first molars indirectly anchored to the inter-radicular mini-screw. | Device | maxillary first molar indirectly anchored to the inter-radicular mini-screw group |
Primary outcome
Amount of anchorage loss of the maxillary first molars
Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
After full canine retraction, the amount of anchorage loss (mesial movement) of the maxillary first molars of will be assessed on the digital models
3 secondary outcomes
Tipping of the maxillary first molar.
Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
Maxillary incisors inclination
Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)
Maxillary incisors anteroposterior position
Time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Mennatallah Ali principal investigator
Cairo 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 archwire stopper mesial to the maxillary first molar group and inter-radicular mini-screw in people with Orthodontic Appliance Complication, run by Cairo 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 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 20 Oct 2026. 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?
Amount of anchorage loss of the maxillary first molars (time frame: 6 months from the start of the canine retraction and after anterior segment retraction (12 months)). 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 20 Oct 2026.