Elastic ChainsCRESTNCT07141836
Effectiveness of Elastic Chains Versus Elastics in Maxillary Canine Retraction
A study testing Elastomeric chain and Elastics in people with Elastic Chains and Elastics, run by Sana'a University at 1 site in Yemen.
Trial summary
This clinical study aimed to evaluate the effectiveness of Elastics and Elastic chains in maxillary canine retraction. Participants of this study were patients undergoing maxillary canine retraction after first premolar extraction. The study aimed to determine an effective method for better controlling tooth movement. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Elastic Chains, Elastics
- What is being tested?
- Elastomeric chain and Elastics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteYemen
- Study dates
- 30 Jan 2024to 1 May 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients' treatment required 1st premolar extractions in the maxillary arch and space closure involving canine retraction.
- Teeth in the buccal segments were without any gross anatomic root anomalies as determined by panoramic radiographs.
- There is no gross evidence of asymmetric bone loss in the buccal segments of a given arch as determined by panoramic radiographs.
- Crown/root ratios of contralateral canines and premolars are within 3 mm of one another as determined by panoramic radiographs.
Who cannot join
- Patients with gross anatomical anomalies in upper maxillary canines
- Patients with growth and development problems.
- Evidence of bone loss.
- Presence of Impacted Canine.
- History of long-term use of NSAIDs and corticosteroids or drugs affect bone metabolism. Patients who reported any medication interfering with bone metabolism or patients with severe skeletal discrepancies indicated for orthognathic treatment.
- Patients with latex materials allergy.
Trial locations and contacts
1 site in 1 country.
Yemen1 site
Deparyment of Orthodontics - Faculty of Dentistry- Sana'a University
Sanaa, 967
About this study
Official title: Evaluation of the Effectiveness ff Elastic Chains Versus Elastics in Maxillary Canine Retraction: A Randomized Clinical Trial
This clinical study aimed to evaluate the effectiveness of Elastics and Elastic chains in maxillary canine retraction. Participants of this study were patients undergoing maxillary canine retraction after first premolar extraction. The study aimed to determine an effective method for better controlling tooth movement.
This study was initiated on 01-2024. Initially, I was not aware of the importance of early registration on ClinicalTrials.gov. Registration was completed after the study began to ensure transparency and adherence to ethical guidelines. All study procedures and protocols have been conducted under the supervision of the academic advisor. All study procedures and protocols have been followed according to institutional and ethical guidelines
Read the detailed description
This split-mouth Randomized clinical trial was conducted on 33 patients who needed maxillary canine retraction. Participants were randomly selected one side to receive an elastic chain and the other for elastics, as a method for canine retraction. The intervention period lasted for 15 weeks, and the elastics were replaced by the patient every three days, while elastic chains were exchanged by the principal investigator at 5-week appointments. The type of movement that occurred with each method was evaluated to measure the rate of tooth movement, tipping, and rotation resulting. The study was conducted under the supervision and approval of the Research Ethics Committee at Sana'a University, Faculty of Dentistry. All procedures were performed according to the approved protocol, ensuring participant safety and data accuracy.
- Conditions
- Elastic Chains, Elastics
- Being tested
- Elastomeric chain, Elastics
- Keywords
- Elastics, Elastomeric chains, Randomized clinical trial, Split mouth, Digital models, Canine retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastomeric chainProcedure or surgery
Also called Elastic chains, Power chain
Elastic chain used to apply force that is capable of canine retraction. The chains were attached between canine bracket and molar band on the side that selected Randomly.
ElasticsProcedure or surgery
Also called Elastic band, Intramaxillary elastic
Elastics were used to bring a continuous force for maxillary canine retraction in orthodontic patients. Elastics were stretched between the canine bracket and the molar band to retract the canine distally
| Study group | Role | What they receive |
|---|---|---|
| Elastic chains | Experimental | This side received maxillary canine retraction using elastic chains Receives: Procedure: Elastomeric chain |
| Elastics | Experimental | This side received maxillary canine retraction with Elastics on the contralateral side of the arch Receives: Procedure: Elastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maxillary canine retraction by elastics and elastic chains on each side
The canine retraction rate was measured on superimposed digital casts of pre and post retraction models.
Measured: Difference between pe and post retraction canine position during 15 weeks
Measurement of the Tipping movement occurred by each method
Tipping angle on each side was measured on Orthopantomograms (OPG).
Measured: Pre and post retraction during 15 weeks
Measurements of rotation resulted by elastic and elastic chain
The rotational angle was measured on each side by the digital models
Measured: Pre and post-retraction during 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start30 Jan 2024
- Primary completion11 Apr 2025
- Study completion1 May 2025
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 Elastic ChainsStudies 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
- Crossover
- Model description
- This study was designed as a split-mouth randomized clinical trial, where each participant received both interventions. One side of the maxillary arch was retracted with elastic chains, while the contralateral side received elastics. This design allows for direct intra-individual comparison between the two force delivery systems.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asraa Haleem Mohamed Tah, Sana'a University
- Investigators
- Asraa H Taha, MSc Student, Principal investigator, Sana'a UniversityReema A Al-Eriani, PhD of Pedodontics, Study director, Sana'a UniversityGhamdan A Al-Harazi, PhD of Orthodontics, Study director, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141836
- Sponsor's protocol ID
- Asraa-H-Ortho
- Acronym
- CREST
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I plan to share de-identified individual participant data (IPD) related to the main outcomes of this study. The data will be available upon reasonable request and after the results are published. Only researchers with valid proposals will be allowed access. Data will be shared through secure methods and only for academic purposes
Publications
Jagtap SB, Bhosale VI, Patil AS. Comparative evaluation of interrupted and intermittent forces on canine retraction: an in vivo study. Folia Med (Plovdiv). 2021 Oct 31;63(5):686-691. doi: 10.3897/folmed.63.e54247.
PubMed 35851202
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness ff Elastic Chains Versus Elastics in Maxillary Canine Retraction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07141836
- Acronym / sponsor ID
- CREST / Asraa-H-Ortho
- Conditions
- Elastic Chains, Elastics
- Keywords
- Elastics, Elastomeric chains, Randomized clinical trial, Split mouth, Digital models, Canine retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 26 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 clinical study aimed to evaluate the effectiveness of Elastics and Elastic chains in maxillary canine retraction. Participants of this study were patients undergoing maxillary canine retraction after first premolar extraction. The study aimed to determine an effective method for better controlling tooth movement.
This study was initiated on 01-2024. Initially, I was not aware of the importance of early registration on ClinicalTrials.gov. Registration was completed after the study began to ensure transparency and adherence to ethical guidelines. All study procedures and protocols have been conducted under the supervision of the academic advisor. All study procedures and protocols have been followed according to institutional and ethical guidelines
Detailed description
This split-mouth Randomized clinical trial was conducted on 33 patients who needed maxillary canine retraction. Participants were randomly selected one side to receive an elastic chain and the other for elastics, as a method for canine retraction. The intervention period lasted for 15 weeks, and the elastics were replaced by the patient every three days, while elastic chains were exchanged by the principal investigator at 5-week appointments. The type of movement that occurred with each method was evaluated to measure the rate of tooth movement, tipping, and rotation resulting. The study was conducted under the supervision and approval of the Research Ethics Committee at Sana'a University, Faculty of Dentistry. All procedures were performed according to the approved protocol, ensuring participant safety and data accuracy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a split-mouth randomized clinical trial, where each participant received both interventions. One side of the maxillary arch was retracted with elastic chains, while the contralateral side received elastics. This design allows for direct intra-individual comparison between the two force delivery systems.
| Arm | Type | Receives |
|---|---|---|
| Elastic chains | Experimental | Procedure: Elastomeric chainThis side received maxillary canine retraction using elastic chains |
| Elastics | Experimental | Procedure: ElasticsThis side received maxillary canine retraction with Elastics on the contralateral side of the arch |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients' treatment required 1st premolar extractions in the maxillary arch and space closure involving canine retraction.
- Teeth in the buccal segments were without any gross anatomic root anomalies as determined by panoramic radiographs.
- There is no gross evidence of asymmetric bone loss in the buccal segments of a given arch as determined by panoramic radiographs.
- Crown/root ratios of contralateral canines and premolars are within 3 mm of one another as determined by panoramic radiographs.
Key exclusion criteria (6 listed)
- Patients with gross anatomical anomalies in upper maxillary canines
- Patients with growth and development problems.
- Evidence of bone loss.
- Presence of Impacted Canine.
- History of long-term use of NSAIDs and corticosteroids or drugs affect bone metabolism. Patients who reported any medication interfering with bone metabolism or patients with severe skeletal discrepancies indicated for orthognathic treatment.
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 |
|---|---|---|
| Elastomeric chainAlso: Elastic chains, Power chainElastic chain used to apply force that is capable of canine retraction. The chains were attached between canine bracket and molar band on the side that selected Randomly. | Procedure or surgery | Elastic chains |
| ElasticsAlso: Elastic band, Intramaxillary elasticElastics were used to bring a continuous force for maxillary canine retraction in orthodontic patients. Elastics were stretched between the canine bracket and the molar band to retract the canine distally | Procedure or surgery | Elastics |
Primary outcome
Rate of maxillary canine retraction by elastics and elastic chains on each side
Time frame: Difference between pe and post retraction canine position during 15 weeks
The canine retraction rate was measured on superimposed digital casts of pre and post retraction models.
Measurement of the Tipping movement occurred by each method
Time frame: Pre and post retraction during 15 weeks
Tipping angle on each side was measured on Orthopantomograms (OPG).
Measurements of rotation resulted by elastic and elastic chain
Time frame: Pre and post-retraction during 25 weeks
The rotational angle was measured on each side by the digital models
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 2 Sep 2025.
- Results publication: PubMed 35851202Jagtap SB, Bhosale VI, Patil AS. Comparative evaluation of interrupted and intermittent forces on canine retraction: an in vivo study. Folia Med (Plovdiv). 2021 Oct 31;63(5):686-691. doi: 10.3897/folmed.63.e54247.
- Comparative evaluation of interrupted and intermittent forces on canine retraction: an in vivo studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. I plan to share de-identified individual participant data (IPD) related to the main outcomes of this study. The data will be available upon reasonable request and after the results are published. Only researchers with valid proposals will be allowed access. Data will be shared through secure methods and only for academic purposes
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.
Asraa H Taha, MSc Student principal investigator
Sana'a University
Reema A Al-Eriani, PhD of Pedodontics study director
Sana'a University
Ghamdan A Al-Harazi, PhD of Orthodontics study director
Sana'a 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 Elastomeric chain and Elastics in people with Elastic Chains and Elastics, run by Sana'a University at 1 site in Yemen.
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 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 Yemen. 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?
Rate of maxillary canine retraction by elastics and elastic chains on each side (time frame: Difference between pe and post retraction canine position during 15 weeks). The study lists 3 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 NCT07141836, 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 2 Sep 2025.