Canine RetractionNCT05643443
Effect of Gradually Increasing Force Magnitude on the Rate of Canine Retraction Randomized Controlled Trial
A study testing Gradual increase of force in people with Canine Retraction, run by Cairo University at 1 site in Egypt.
Trial summary
Therefore the aim of the current randomized controlled clinical trial is to investigate the effect of gradually increasing force magnitude versus constant force magnitude on the rate of tooth movement in a canine retraction model, furthermore investigate the effect of the two force systems on the ratio of cytokines… Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Canine Retraction
- What is being tested?
- Gradual increase of force
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Mar 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 16 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Males and Females with an age ranging between 16-30 years (Adult patients since cooperation increases with age) (17).
- Malocclusion that requires extraction of the maxillary first premolars and canines retraction with moderate anchorage.
- Full permanent dentition with exception of the third molars.
- Good oral hygiene and periodontal condition (Probing depth< 4 mm in all teeth), since the periodontal condition affects the amount and type of tooth movement.
- Absence of untreated caries which may worsen during the study time.
Who cannot join
- Medically compromised patients.
- Patients suffering from any congenital or hereditary diseases.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gradually Increasing Force Magnitude on the Rate of Canine Retraction: A Split Mouth Randomized Controlled Trial
Therefore the aim of the current randomized controlled clinical trial is to investigate the effect of gradually increasing force magnitude versus constant force magnitude on the rate of tooth movement in a canine retraction model, furthermore investigate the effect of the two force systems on the ratio of cytokines and the pain experienced by the patient.
Research question:
In adult orthodontic patients requiring bilateral maxillary canines retraction, will gradually increasing force magnitudes accelerate the rate of canine retraction in the experimental side when compared to the control side?
Read the detailed description
- -Patient preparation:
- After patient selection, routine orthodontic records will be collected (study models, panoramic, lateral cephalometric radiographs, and intra-oral and extra-oral photographs).
- The orthodontic treatment: All subjects will receive a Straight Wire Appliance (SWA); Roth prescription slot 0.022 × 0.028 inch. The brackets will be bonded to the tooth surface using orthodontic light cured composite resin. Ready-made molar bands with 2 buccal tubes (main and auxiliary)1 will be selected, fitted, and cemented on the upper first molars using glass ionomer cement. The arch wire sequence in the initial levelling and alignment stage will be tailored according to the severity of crowding of each case.
- Just before canine retraction, alginate impressions will be made for the maxillary arch, CGF sample will be taken as described later in the same section, stainless steel arch wire 0.017 x 0.025 mil will be inserted.
- Canine Retraction:
- The active group (gradually increasing force magnitude) will be randomly assigned to either the patients' left or right sides only (split mouth design).
- At the start of canine retraction, Nickel-titanium closed-coil springs applying 50 g and 150 g measured using Correx tension gauge will be used in the active side and control sides respectively on each side, stretched bilaterally from the hook on the first molar band to the hook of canine brackets(19).
- Activation will be done every 4 weeks.
- The impressions will be poured with dental stone within 15 minutes to ensure its accuracy.
- Visual analogue scale (VAS) will be explained to the patient and used to measure pain intensity in the postoperative period: immediately after the commencement of canine retraction and at each visit. The patient is asked to make three pain ratings each time to take an average. (one day, second day and one week after)
- Conditions
- Canine Retraction
- Being tested
- Gradual increase of force
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual increase of forceOther
Also called 150 gm
steady force
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control Group |
| Active Group | Experimental | Active Group Receives: Other: Gradual increase of force |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
mm/time
Measured: 4 months
change on the Cytokine levels in the gingival crevicular fluid
ratio
Measured: 3 months
Secondary outcomes (1)
The effect of gradually increasing force magnitude on Pain
numeric Pain scale ( 0 as no Pain - 10 As maximum Pain)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionMar 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 Canine RetractionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Abd ElSalam Rizk ElEsh, Cairo University
- Investigators
- Mona Salah Fayed, Professor, Study chair, Cairo University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643443
- Sponsor's protocol ID
- ORTH 3-3-3-3
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Salam SA, Aboalnaga AA, Tawfik WA, Salah Fayed MM. Effect of gradually increasing force magnitude on the rate of canine retraction: a split mouth randomized controlled trial. BMC Oral Health. 2026 Apr 21;26(1):756. doi: 10.1186/s12903-026-08243-4.
PubMed 42015068
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gradually Increasing Force Magnitude on the Rate of Canine Retraction: A Split Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05643443
- Acronym / sponsor ID
- ORTH 3-3-3-3
- Conditions
- Canine Retraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 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.
Therefore the aim of the current randomized controlled clinical trial is to investigate the effect of gradually increasing force magnitude versus constant force magnitude on the rate of tooth movement in a canine retraction model, furthermore investigate the effect of the two force systems on the ratio of cytokines and the pain experienced by the patient.
Research question:
In adult orthodontic patients requiring bilateral maxillary canines retraction, will gradually increasing force magnitudes accelerate the rate of canine retraction in the experimental side when compared to the control side?
Detailed description
- -Patient preparation:
- After patient selection, routine orthodontic records will be collected (study models, panoramic, lateral cephalometric radiographs, and intra-oral and extra-oral photographs).
- The orthodontic treatment: All subjects will receive a Straight Wire Appliance (SWA); Roth prescription slot 0.022 × 0.028 inch. The brackets will be bonded to the tooth surface using orthodontic light cured composite resin. Ready-made molar bands with 2 buccal tubes (main and auxiliary)1 will be selected, fitted, and cemented on the upper first molars using glass ionomer cement. The arch wire sequence in the initial levelling and alignment stage will be tailored according to the severity of crowding of each case.
- Just before canine retraction, alginate impressions will be made for the maxillary arch, CGF sample will be taken as described later in the same section, stainless steel arch wire 0.017 x 0.025 mil will be inserted.
- Canine Retraction:
- The active group (gradually increasing force magnitude) will be randomly assigned to either the patients' left or right sides only (split mouth design).
- At the start of canine retraction, Nickel-titanium closed-coil springs applying 50 g and 150 g measured using Correx tension gauge will be used in the active side and control sides respectively on each side, stretched bilaterally from the hook on the first molar band to the hook of canine brackets(19).
- Activation will be done every 4 weeks.
- The impressions will be poured with dental stone within 15 minutes to ensure its accuracy.
- Visual analogue scale (VAS) will be explained to the patient and used to measure pain intensity in the postoperative period: immediately after the commencement of canine retraction and at each visit. The patient is asked to make three pain ratings each time to take an average. (one day, second day and one week after)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control Group |
| Active Group | Experimental | Other: Gradual increase of forceActive Group |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males and Females with an age ranging between 16-30 years (Adult patients since cooperation increases with age) (17).
- Malocclusion that requires extraction of the maxillary first premolars and canines retraction with moderate anchorage.
- Full permanent dentition with exception of the third molars.
- Good oral hygiene and periodontal condition (Probing depth< 4 mm in all teeth), since the periodontal condition affects the amount and type of tooth movement.
- Absence of untreated caries which may worsen during the study time.
Key exclusion criteria (4 listed)
- Medically compromised patients.
- Patients suffering from any congenital or hereditary diseases.
- 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 |
|---|---|---|
| Gradual increase of forceAlso: 150 gmsteady force | Other | Active Group |
Primary outcome
Rate of canine retraction
Time frame: 4 months
mm/time
change on the Cytokine levels in the gingival crevicular fluid
Time frame: 3 months
ratio
1 secondary outcome
The effect of gradually increasing force magnitude on Pain
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 42015068El-Salam SA, Aboalnaga AA, Tawfik WA, Salah Fayed MM. Effect of gradually increasing force magnitude on the rate of canine retraction: a split mouth randomized controlled trial. BMC Oral Health. 2026 Apr 21;26(1):756. doi: 10.1186/s12903-026-08243-4.
- Individual participant dataSharing planned: No
Related trials for Canine Retraction
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Enrolling by invitation
Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
Recruiting
Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection
Accelerate Tooth Movement
Enrolling by invitation
Comparison of Maxillary Canine Retraction Rate With and Without Power Arm
Orthodontic Anchorage, Power Arm Sliding
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 Salah Fayed, Professor study chair
Cairo University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual increase of force in people with Canine Retraction, 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 5 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: status not confirmed, as of the sponsor's last update on 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shady Abd ElSalam, PhD (00201008815748, dr.shadyabdelsalam@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of canine retraction (time frame: 4 months). 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?
On the ClinicalTrials.gov record for NCT05643443, 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 8 Dec 2022.