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Class II Division 1 MalocclusionNCT06875037

Patient-related Outcomes When Accelerating Upper Canine Retraction With Fixed Orthodontic Appliances

A study testing Electric stimulation removable appliance and Traditional orthodontic fixed appliance without accleration in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients will be screened in the Orthodontics Department of the Faculty of Dentistry, Damascus University, and those who meet the inclusion criteria will be included. Then, the initial diagnostic records (diagnostic plaster casts, intra- and extra-oral photographs, and radiographs) will be studied to ensure the… Read more about this study

Who is it for?
Ages 17 to 25 years
Conditions the study is for
Class II Division 1 Malocclusion
What is being tested?
Electric stimulation removable appliance and Traditional orthodontic fixed appliance without accleration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSyria
Study dates
1 May 2023to 1 Dec 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 17 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adults aged 17 to 28 years.
  • Class II Division 1 malocclusion (according to Angle's classification) requires the extraction of the upper first premolar as part of the orthodontic treatment plan.
  • Mild to moderate skeletal Class II (ANB = 5-7).
  • Overjet of 5 to 10 mm.
  • Normal or vertical growth patterns (MM ≥ 26; SN-MP ≥ 33; Y Axis ≥ 65)

Who cannot join

  • Moderate to severe dental crowding.
  • Missing teeth in the upper arch.
  • Previous orthodontic treatment.
  • Health conditions or long-term medication.
  • Periodontal disease.
  • Poor oral hygiene.
  • Smoking

Trial locations and contacts

1 site in 1 country.

Syria1 site
  • Department of Orthodontics, Faculty of Dentistry, University of Damascus

    Damascus, DM20AM19

Other trials in Syria

About this study

Official title: Patient-reported Outcomes of Accelerated Upper Canine Retraction With Low-amperage Electrical Stimulation: A Randomized Controlled Trial

Patients will be screened in the Orthodontics Department of the Faculty of Dentistry, Damascus University, and those who meet the inclusion criteria will be included. Then, the initial diagnostic records (diagnostic plaster casts, intra- and extra-oral photographs, and radiographs) will be studied to ensure the selection criteria are accurately met.

This study aims to compare two groups of patients with Class II malocclusion. Experimental Group: Patients in this group will undergo maxillary canine retraction using the traditional sliding technique with fixed appliances, supplemented by electrical current stimulation.

Control Group: Patients in this group will undergo maxillary canine retraction using the traditional sliding technique with fixed appliances, without any acceleration method.

Read the detailed description

Maxillary canine retraction can be lengthy, and various methods have been employed to accelerate it. Electrical current stimulation has shown promise as a technique for speeding up tooth movement. However, only a limited number of studies have been documented in the literature. Controlled clinical studies are necessary to evaluate the effectiveness of this procedure in accelerating tooth movement, its impact on pain responses, and other patient-centred outcomes.

Participants will be selected from patients attending the Orthodontics Department at the Faculty of Dentistry, Damascus University. Eligible patients with Class II/Division I malocclusion who meet the inclusion criteria will be invited to participate in this trial after being screened by the researcher. Informed consent will be obtained from all patients who agree to join the study after receiving an information sheet.

Alignment and leveling will be performed using pre-adjusted fixed orthodontic appliances consisting of 0.022 x 0.028-inch metal brackets with the MBT prescription. The traditional wiring sequence will be followed until a 0.019 x 0.025-inch stainless steel base wire is in place.

Maxillary first premolars will be extracted during the leveling and alignment phase, with more than two months between the completion of the alignment phase and the extraction. This ensures that the phenomenon of regional acceleration generated by the extraction does not affect the rate of tooth movement.

Canine retraction will be achieved using closed-coil nickel-titanium (NiTi) springs extending from the upper first molar band hook to the canine bracket hook. A force of 150 grams will be applied to each side, and the force will be checked using a force meter at each appointment (every two weeks) until the canine retraction is complete, achieving a Class I canine relationship.

A small electrical current will be applied to the upper maxillary canine area using a removable intraoral appliance containing a micro electrical circuit. Each patient in the experimental group will be asked to wear the electrical accelerator in their mouth for 5 hours daily.

Being tested
Electric stimulation removable appliance, Traditional orthodontic fixed appliance without accleration
Medical subject headings
Malocclusion, Angle Class II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electric stimulation removable applianceDevice

    The device will be used with the fixed appliance to accelerate orthodontic tooth movement (i.e., canine retraction).

  • Traditional orthodontic fixed appliance without acclerationProcedure or surgery

    The traditional method of canine retraction will be employed using fixed appliances. No additional appliances will be used to activate orthodontic tooth movement.

Study groups in NCT06875037
Study groupRoleWhat they receive
Electrical Stimulation GroupExperimentalPatients in this group will undergo conventional orthodontic treatment combined with electrical stimulation for the retraction of upper canines.
Receives: Device: Electric stimulation removable appliance
Conventional Traction GroupActive comparatorPatients in this group will receive conventional orthodontic treatment without any acceleration method.
Receives: Procedure: Traditional orthodontic fixed appliance without accleration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the perception of pain

    Patients will be asked to rate their pain perception with the question, "What is the degree of pain you are experiencing at this moment?" They will indicate their pain level by placing a mark on a horizontal 100-mm line. The left end of the line represents no pain (VAS=0), and the right end signifies maximum (unimaginable) pain (VAS=100).

    Measured: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

  2. Change in the perception of discomfort

    Patients will be asked to rate their perception of discomfort with the question, "What is the degree of discomfort you are experiencing at this moment?" They will indicate their level of discomfort by placing a mark on a horizontal 100-mm line. The left end of the line represents no discomfort (VAS=0), while the right end signifies maximum (unimaginable) discomfort (VAS=100).

    Measured: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

Secondary outcomes (6)
  1. Change in difficulty swallowing

    Patients will be asked to rate their perception of difficulty swallowing with the question, "What is the degree of difficulty swallowing you are experiencing at this moment?" They will indicate their level of difficulty swallowing by placing a mark on a horizontal 100-mm line. The left end of the line represents no difficulty swallowing (VAS=0), while the right end signifies maximum difficulty swallowing (VAS=100).

    Measured: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

  2. Change in the chewing ability

    Patients will be asked to rate their perception of chewing ability with the question, "What is the degree of difficulty you are experiencing in chewing?" They will indicate their level of chewing difficulty by placing a mark on a horizontal 100-mm line. The left end of the line represents no difficulty (VAS=0), while the right end signifies maximum difficulty in mastication (VAS=100).

    Measured: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

  3. Change in the speech ability

    Patients will be asked to rate their perception of speech ability with the question, "What is the degree of difficulty you are experiencing in speech?" They will indicate their level of speech difficulty by placing a mark on a horizontal 100-mm line. The left end of the line represents no difficulty (VAS=0), while the right end signifies maximum difficulty (VAS=100).

    Measured: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

  4. Change in analgesic consumption

    Patients will be asked the following question about "Analgesic Consumption": "Did you need to take pain analgesics?" Analgesic consumption is assessed by inquiring if the study participant took analgesics, using a two-point scale (1. Yes or 2. No).

    Measured: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine retraction.

  5. Patients' satisfaction

    Patients will be asked to evaluate their satisfaction with orthodontic treatment with the question, "How satisfied are you with your orthodontic treatment?" Satisfaction for both groups will be assessed by having the study participant place a mark on a horizontal 100-mm line to indicate their level of satisfaction. The left end of the line represents no satisfaction (VAS=0), while the right end signifies maximum satisfaction (VAS=100).

    Measured: Questionnaires will be filled at the end of the fourth month of the canine retraction

  6. Recommendation of the procedure to a friend

    Patients will be asked the following question about the likelihood of recommending the procedure to their friends: "Would you recommend this treatment to a friend?" Those in the experimental group will indicate their response using a two-point scale (1. Yes, or 2. No).

    Measured: Questionnaires will be filled at the end of the fourth month of the canine retraction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study start1 May 2023
  3. Primary completion6 Apr 2024
  4. Study completion1 Dec 2024

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06875037
Sponsor's protocol ID
UDDS-Ortho-4-2025
Status last verified
Mar 2025
First submitted
8 Mar 2025
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mousa MM, Hajeer MY, Burhan AS, Darwich KMA, Almahdi WH, Aljabban O, Awawdeh MA, Almasri IA. Patient-Reported Outcome Measures of Flapless Corticotomy with Low-Level Laser Therapy in En Masse Retraction of Upper Anterior Teeth: A Three-Arm Randomized Controlled Trial. Clin Pract. 2023 Nov 22;13(6):1501-1519. doi: 10.3390/clinpract13060132.

    PubMed 38131681
  • Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.

    PubMed 35796046
  • Shaadouh RI, Hajeer MY, Mahmoud GA, Almasri IA, Jaber ST, Alam MK. Patient-reported outcomes during accelerating the en-masse retraction of the upper anterior teeth using low-intensity electrical stimulation: a randomized controlled trial. Prog Orthod. 2024 May 13;25(1):17. doi: 10.1186/s40510-024-00517-3.

    PubMed 38735912
  • Alfailany DT, Hajeer MY, Awawdeh MA, Khursheed Alam M, Darwich KMA, Aljabban O, Latifeh Y, Alhaffar JB, Almasri IA. Evaluation of Patient-Reported Outcome Measures (PROMs) Associated With the Acceleration of Canine Retraction by Piezosurgery in Comparison With Low-Level Laser Therapy: A Three-Arm Randomized Controlled Clinical Trial. Cureus. 2024 Jan 7;16(1):e51779. doi: 10.7759/cureus.51779. eCollection 2024 Jan.

    PubMed 38192530
  • Charavet C, Lecloux G, Jackers N, Maes N, Lambert F. Patient-reported outcomes measures (PROMs) following a piezocision-assisted versus conventional orthodontic treatments: a randomized controlled trial in adults. Clin Oral Investig. 2019 Dec;23(12):4355-4363. doi: 10.1007/s00784-019-02887-z. Epub 2019 Apr 6.

    PubMed 30955096
  • Kheshfeh MN, Hajeer MY, Alam MK, Al Hinnawi MF, Latifeh Y. Patient-reported outcome measures of accelerated upper canine retraction with low-amperage electrical stimulation: A randomized controlled trial. Int Orthod. 2026 Mar;24(1):101077. doi: 10.1016/j.ortho.2025.101077. Epub 2025 Oct 3.

    PubMed 41045595

Questions about this trial

What is this clinical trial studying?

A study testing Electric stimulation removable appliance and Traditional orthodontic fixed appliance without accleration in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.

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 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 Mar 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 Syria. 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?

Change in the perception of pain (time frame: Questionnaires will be completed at the following assessment times: on the 1st, 3rd, and 7th days of the first, second, and third months from the start of the canine 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?

On the ClinicalTrials.gov record for NCT06875037, which also lists 6 linked publications.

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 Mar 2025.

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