Orthodontic Patients Indicated for Upper First Premolar ExtractionNCT07116954
Root Resorption and Alveolar Bone Changes in the Maxillary Canine Retraction Using Ni Ti Closed-coil Springs Versus Elastomeric Chains (A Split -Mouth Cone Beam CT Study)
A study testing Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group. and Canin retraction with NiTi Closed-Coil Springs and elastomeric chains in people with Orthodontic Patients Indicated for Upper First Premolar Extraction and Orthodontic Patients Indicated for Maxillary Canine Retraction, run by Al-Azhar University.
Trial summary
This study will be carried out to asses root resorption and alveolar bone changes in the maxillary canine retraction using NiTi closed-coil springs versus elastomeric chains with cone beam CT Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Orthodontic Patients Indicated for Upper First Premolar Extraction, Orthodontic Patients Indicated for Maxillary Canine Retraction
- What is being tested?
- Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group. and Canin retraction with NiTi Closed-Coil Springs and elastomeric chains
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 16 years or older
- Patients indicated for fixed orthodontic appliances
- Patients indicated for bilateral extraction of maxillary first premolars
- Patients who have not undergone any previous orthodontic treatment
Who cannot join
- Patients with a history of craniofacial trauma, anomalies, or congenital defects
- Patients currently taking anticoagulant drugs affecting bone metabolism
- Patients with a history of trauma or pathology involving the maxillary canines
- Patients with periodontally compromised teeth
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will be carried out to asses root resorption and alveolar bone changes in the maxillary canine retraction using NiTi closed-coil springs versus elastomeric chains with cone beam CT
- Conditions
- Orthodontic Patients Indicated for Upper First Premolar Extraction, Orthodontic Patients Indicated for Maxillary Canine Retraction
- Being tested
- Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group., Canin retraction with NiTi Closed-Coil Springs and elastomeric chains
- Keywords
- Niti coil springs, Canine Retraction, Elastomeric Chains, Root resorption, CBCT
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group.Procedure or surgery
Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be used on the left side. Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on the left side.
Canin retraction with NiTi Closed-Coil Springs and elastomeric chainsProcedure or surgery
Comparison between canine retraction using NiTi closed-coil springs versus elastomeric chains
| Study group | Role | What they receive |
|---|---|---|
| Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be use | Experimental | Not described Receives: Procedure: Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group.; Procedure: Canin retraction with NiTi Closed-Coil Springs and elastomeric chains |
| Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on | Experimental | Not described Receives: Procedure: Canin retraction with NiTi Closed-Coil Springs and elastomeric chains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apical Root Length After Canine Retraction
Measurement of apical root length (in millimeters) using CBCT images at T1 and T2 to assess root resorption on both retraction methods.
Measured: Baseline (prior to canine retraction) and 6 months after retraction
Change in Alveolar Bone Thickness After Canine Retraction
Quantitative measurement of alveolar bone thickness (in millimeters) using CBCT images taken at baseline (T1) and post-treatment (T2) in both NiTi closed-coil spring and elastomeric chain sides.
Measured: Baseline (prior to canine retraction) and 6 months after retraction
Secondary outcomes (3)
Change in Probing Depth
Measurement of probing depth (in millimeters) on both sides at baseline and 6 months
Measured: Baseline and 6 months post-treatment
Change in Plaque Index
Scoring of plaque accumulation using the Silness-Löe Plaque Index (score range: 0 to 3; higher score = worse outcome)
Measured: Baseline and 6 months post-treatment
Change in Bleeding Index
Evaluation using the Gingival Bleeding Index (score range: 0 to 3; higher score = worse outcome)
Measured: Baseline and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Patients Indicated for Upper First Premolar ExtractionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hassan Mahdy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116954
- Sponsor's protocol ID
- Ethical committee
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including CBCT-based measurements of alveolar bone height and root resorption, will be shared. Data will be available beginning 6 months after study completion via a secure external repository (link will be provided in the References section). Access will be granted to researchers upon request and subject to approval.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root Resorption and Alveolar Bone Changes in the Maxillary Canine Retraction Using Ni Ti Closed-coil Springs Versus Elastomeric Chains (A Split -Mouth Cone Beam CT Study)
- ClinicalTrials.gov ID
- NCT07116954
- Acronym / sponsor ID
- Ethical committee
- Conditions
- Orthodontic Patients Indicated for Upper First Premolar Extraction, Orthodontic Patients Indicated for Maxillary Canine Retraction
- Keywords
- Niti coil springs, Canine Retraction, Elastomeric Chains, Root resorption, CBCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
This study will be carried out to asses root resorption and alveolar bone changes in the maxillary canine retraction using NiTi closed-coil springs versus elastomeric chains with cone beam CT
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be use | Experimental | Procedure: Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group., Procedure: Canin retraction with NiTi Closed-Coil Springs and elastomeric chains |
| Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on | Experimental | Procedure: Canin retraction with NiTi Closed-Coil Springs and elastomeric chains |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group.Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be used on the left side. Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on the left side. | Procedure or surgery | Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be use |
| Canin retraction with NiTi Closed-Coil Springs and elastomeric chainsComparison between canine retraction using NiTi closed-coil springs versus elastomeric chains | Procedure or surgery | Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be use, Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on |
Primary outcome
Change in Apical Root Length After Canine Retraction
Time frame: Baseline (prior to canine retraction) and 6 months after retraction
Measurement of apical root length (in millimeters) using CBCT images at T1 and T2 to assess root resorption on both retraction methods.
Change in Alveolar Bone Thickness After Canine Retraction
Time frame: Baseline (prior to canine retraction) and 6 months after retraction
Quantitative measurement of alveolar bone thickness (in millimeters) using CBCT images taken at baseline (T1) and post-treatment (T2) in both NiTi closed-coil spring and elastomeric chain sides.
3 secondary outcomes
Change in Probing Depth
Time frame: Baseline and 6 months post-treatment
Change in Plaque Index
Time frame: Baseline and 6 months post-treatment
Change in Bleeding Index
Time frame: Baseline and 6 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including CBCT-based measurements of alveolar bone height and root resorption, will be shared. Data will be available beginning 6 months after study completion via a secure external repository (link will be provided in the References section). Access will be granted to researchers upon request and subject to approval.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group. and Canin retraction with NiTi Closed-Coil Springs and elastomeric chains in people with Orthodontic Patients Indicated for Upper First Premolar Extraction and Orthodontic Patients Indicated for Maxillary Canine Retraction, run by Al-Azhar University.
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 4 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: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed Hassan Mahdy, Bds (+201119808935, Ah4723045@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apical Root Length After Canine Retraction (time frame: Baseline (prior to canine retraction) and 6 months after retraction). The study lists 2 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 12 Aug 2025.