Class II Division 1 MalocclusionNCT04905004
Efficiency of Canine Retraction Using Different Reactivation Intervals
A study testing Canine retraction in people with Class II Division 1 Malocclusion and Class III Malocclusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion, Class III Malocclusion, Bimaxillary Protrusion
- What is being tested?
- Canine retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Jun 2022
- 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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
- Erupted full set of permanent teeth (excluding 3rd molars)
Who cannot join
- Systemic diseases that would interfere with bone metabolism
- Craniofacial syndromes
- congenitally missing or extracted permanent teeth.
- periodontally compromised patients
- smokers
- pregnant women
- previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt
Cairo, 11865
Yehya Mostafa, PhD, yehya3d@gmail.com
About this study
Official title: Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals
Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.
Read the detailed description
The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.
- Conditions
- Class II Division 1 Malocclusion, Class III Malocclusion, Bimaxillary Protrusion, Crowding, Tooth
- Being tested
- Canine retraction
- Medical subject headings
- Malocclusion, Angle Class II, Malocclusion, Angle Class III, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canine retractionProcedure or surgery
Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
| Study group | Role | What they receive |
|---|---|---|
| 2-week reactivation interval | Experimental | Replacement of elastomeric chain every 2 weeks and reestablishing a 150 g force Receives: Procedure: Canine retraction |
| 4-week reactivation interval | Active comparator | Replacement of elastomeric chain every 4 weeks and reestablishing a 150 g force Receives: Procedure: Canine retraction |
| 6-week reactivation interval | Experimental | Replacement of elastomeric chain every 6 weeks and reestablishing a 150 g force Receives: Procedure: Canine retraction |
| 8-week reactivation interval | Experimental | Replacement of elastomeric chain every 8 weeks and reestablishing a 150 g force Receives: Procedure: Canine retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of canine retraction
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Measured: Baseline to 1 month
Rate of canine retraction
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Measured: 1month to 2 months
Rate of canine retraction
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Measured: 2 months to 3 months
Rate of canine retraction
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Measured: 3 months to 4 months
Rate of canine retraction
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Measured: 4 months to 5 months
Rate of canine retraction
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Measured: 5 months to 6 months.
Secondary outcomes (15)
Amount of canine retraction
The change in distance measured from the canine cusp tip to the frontal plane, in millimeters; measured on CBCT
Measured: Baseline to 6 months
Canine tipping
CBCT images at T0 and T1 were analyzed using Invivo 5 software. linear measurements were made from the long axis of the canines (cusp tip to root apex) to FP1 and FP2 for the upper and lower canines, respectively.
Measured: Baseline to 6 months
Canine rotation
The change in the angle between a line connecting the maximum mesial and distal crown convexities and FP1 and FP2, for the upper and lower canines, respectively; measured on CBCT
Measured: Baseline to 6 months
Canine root resorption
The change in the canine length, in millimeters, measured from cusp tip to root apex; measured on CBCT
Measured: Baseline to 6 months
First molar anchorage loss
The change in distance measured from the mesio-buccal cusp tip of the first molar to the frontal plane, in millimeters; measured on CBCT
Measured: Baseline to 6 months
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: baseline to day 1
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 2
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 3
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 4
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 5
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 6
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 7
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 8
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 9
Pain score
The patient makes a mark along the Visual Analogue Scale (VAS) scale denoting the severity of pain: 0-100 0= no pain and 100= worst pain imaginable
Measured: Baseline to day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Apr 2017
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehya Mostafa, Future University in Egypt
- Investigators
- Yehya Mostafa, PhD, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905004
- Sponsor's protocol ID
- 20153110-8-14-2017
- Status last verified
- May 2021
- First submitted
- 23 May 2021
- Last updated
- 27 May 2021
- 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 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Canine Retraction Using Two-week, Four-week, Six-week and Eight-week Reactivation Intervals
- ClinicalTrials.gov ID
- NCT04905004
- Acronym / sponsor ID
- 20153110-8-14-2017
- Conditions
- Class II Division 1 Malocclusion, Class III Malocclusion, Bimaxillary Protrusion, Crowding, Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 27 May 2021 (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.
Canine retraction after 1st premolar extracion into the extraction space is a routine treatment in orthodontics. Orthodontic patients requiring first premolar extraction, canine retraction and maximum anchorage were recruited for this randomized controlled trial. A search of the literature did not indicate the ideal frequency of elastomeric chain reactivation for optimum canine retraction. The study was approved by the ethical committee. The first premolars were extracted. Elastomeric chains were used to retract the canine distally into the 1st premolar space. The optimum reactivation interval was evaluated regarding the efficiency of treatment in terms of rate of canine retraction, canine tipping and rotation, root resorption and pain at the intervals of 2, 4, 6 and 8 weeks. Three dimensional imaging, as well as digital scanning were the methods for data collection.
Detailed description
The canines, 2nd premolars, 1st molars and 2nd molars were bonded and banded. Leveling and alignment was achieved. After the first premolar extraction, temporary anchorage devices were inserted interradicular between 2nd premolar and 1st molar. Canine retraction was performed on a 0.016" X 0.022" stainless steel arch wire. A power arm was extended to apply the force closer to the center of resistance and achieve bodily movement. Elastomeric chains were calibrated to deliver a force of 150g and extended from the power arm to the mini screws directly. Recruited patients were randomly allocated to four groups according to the duration between the elastomeric chain reactivation. Canine reactivation intervals were 2, 4, 6, or 8 weeks. Cone beam computed tomography was performed before canine retraction and after 6 months of retraction. Digital dental casts were taken before canine retraction and monthly for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2-week reactivation interval | Experimental | Procedure: Canine retractionReplacement of elastomeric chain every 2 weeks and reestablishing a 150 g force |
| 4-week reactivation interval | Active comparator | Procedure: Canine retractionReplacement of elastomeric chain every 4 weeks and reestablishing a 150 g force |
| 6-week reactivation interval | Experimental | Procedure: Canine retractionReplacement of elastomeric chain every 6 weeks and reestablishing a 150 g force |
| 8-week reactivation interval | Experimental | Procedure: Canine retractionReplacement of elastomeric chain every 8 weeks and reestablishing a 150 g force |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients requiring 1st premolar extraction (e.g bimaxillary dentoalveolar protrusion)
- Erupted full set of permanent teeth (excluding 3rd molars)
Key exclusion criteria (7 listed)
- Systemic diseases that would interfere with bone metabolism
- Craniofacial syndromes
- congenitally missing or extracted permanent teeth.
- periodontally compromised patients
- smokers
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 |
|---|---|---|
| Canine retractionCanines will be retracted using short elastomeric chains. Force applied to canines will be 150g. | Procedure or surgery | 2-week reactivation interval, 4-week reactivation interval, 6-week reactivation interval, 8-week reactivation interval |
Primary outcome
Rate of canine retraction
Time frame: Baseline to 1 month
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Rate of canine retraction
Time frame: 1month to 2 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Rate of canine retraction
Time frame: 2 months to 3 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Rate of canine retraction
Time frame: 3 months to 4 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Rate of canine retraction
Time frame: 4 months to 5 months
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
Rate of canine retraction
Time frame: 5 months to 6 months.
The distance measured between the canine cusp tips for each two consecutive digital models superimposed on the right and left medial palatal rugae.
15 secondary outcomes
Amount of canine retraction
Time frame: Baseline to 6 months
Canine tipping
Time frame: Baseline to 6 months
Canine rotation
Time frame: Baseline to 6 months
Canine root resorption
Time frame: Baseline to 6 months
First molar anchorage loss
Time frame: Baseline to 6 months
Pain score
Time frame: baseline to day 1
Pain score
Time frame: Baseline to day 2
Pain score
Time frame: Baseline to day 3
Pain score
Time frame: Baseline to day 4
Pain score
Time frame: Baseline to day 5
Pain score
Time frame: Baseline to day 6
Pain score
Time frame: Baseline to day 7
Pain score
Time frame: Baseline to day 8
Pain score
Time frame: Baseline to day 9
Pain score
Time frame: Baseline to day 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- 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.
Yehya Mostafa, PhD study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canine retraction in people with Class II Division 1 Malocclusion and Class III Malocclusion, run by Future University in Egypt 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 2 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: status not confirmed, as of the sponsor's last update on 27 May 2021. 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 Reem ElShazly, MSc (+201114666516, reemhazem24@gmail.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: Baseline to 1 month). The study lists 6 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 27 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.