Class II Malocclusion, Division 1NCT05920525

Pain, Discomfort, and Acceptance During Using Electrical Stimulation to Accelerate Orthodontic Teeth Movement

A study testing Electrical stimulation and Traditional retraction of the front upper teeth in people with Class II Malocclusion, Division 1, 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

Who is it for?: Ages 17 to 25 years
Conditions the study is for: Class II Malocclusion, Division 1
What is being tested?: Electrical stimulation and Traditional retraction of the front upper teeth
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSyria
Study dates: 15 Mar 2021to 15 May 2023
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

Adult healthy patients of both sexes
Age range: 17-25 years.
Class II Division 1 malocclusion:
Mild to moderate skeletal Class II (ANB = 5-7)
Protrusion less than 10 mm (5 to 10 mm of overjet)
Normal or vertical growth pattern (MM ≥ 26; SN-MP ≥ 33; Y Axis ≥ 65)

Show all 13Show fewer

Dental crowding less than 3 mm
The presence of all permanent upper teeth (regardless of third molars).
Good oral and periodontal health:
Probing depth < 4 mm
No radiographic evidence of bone loss.
Gingival index ≤ 1
Plaque index ≤ 1

Who cannot join

Patients with previous orthodontic treatment.
Patients with severe skeletal dysplasia in all three dimensions.
Patients suffer from systemic diseases or syndromes
Patients on medication for systemic disorders, pregnancy, or steroid therapy.
Patients showing any signs of active periodontal disease

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72

Other trials in Syria

About this study

Official title: Evaluation of Patient-reported Outcome Measures (PROMs) During Accelerating the En-masse Retraction of Upper Anterior Teeth Using a Low-intensity Direct Electrical Current: A Randomized Controlled Clinical Trial

Forty patients with class II division 1 malocclusion who will require extraction of the upper first premolars as a part of the orthodontic treatment plan will be invited to participate in the study. They will be divided randomly into two groups: the electrical group and the control group. The en-masse retraction technique will be used to retract the upper anterior teeth using mini-implants as an anchor unit to provide the maximum anchorage and Nickle-Titanium closed coil springs that will be stretched from the mini-implants to the crimpable hooks on the base wire and applied 250 g of force per side.

A special removable electrical device will be used to provide electrical stimulation during the retraction phase.

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales.

Read the detailed description

Participants will be chosen from the patients attending the Department of Orthodontics in the Faculty of Dentistry at Damascus University. patients will be examined by the researcher, and any patient with class II division I malocclusion who meets the inclusion criteria will invite to participate in this trial. After giving them the information sheet, informed consent will be obtained from all patients who agreed to join the study.

Leveling and alignment will be performed using pre-adjusted fixed orthodontic appliances of 0.022 x 0.028-inch slot metal bracket with MBT prescription; the conventional wiring sequence will be followed until a 0.019 x 0.025 Stainless Steel base wire is attached.

The maxillary first premolars will be extracted, and skeletal anchoring will be applied before leveling and alignment will begin for all patients. self-drilling orthodontic mini-implants (diameter: 1.6 mm; length: 8 mm) will be placed between the roots of the maxillary second premolar and the first molar on each side.

The en-masse retraction will be done using Nickle-Titanium (NiTi) closed coil springs that stretched from crimpable hooks on the base wire to the mini-implants and applied 250 g of force per side. The force will be examined using a force gauge at every appointment (two weeks) until the completion of the retraction of the upper anterior (reaching a class I canine relationship and a correct incisor relationship).

A micro electrical current will be applied on the upper anterior teeth area using a removable intraorally device containing a small electrical circuit. Each patient in the experimental group will be asked to apply the electric accelerating device in the mouth for 5 hours daily.

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales. 24 hours following the springs activation (T1), three days (T2), and one week (T3).

Conditions: Class II Malocclusion, Division 1
Being tested: Electrical stimulation, Traditional retraction of the front upper teeth
Keywords: Retraction of upper anterior teeth, Electrical stimulation, Coil springs
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.

Electrical stimulationDevice
A specific device will be used to stimulate the remodeling procedures in the alveolar bone.
Traditional retraction of the front upper teethProcedure or surgery
The retraction will be performed using coil springs which will help in moving the anterior teeth backward without the need to employ any additional procedure or device to accelerate this movement.

Study groups in NCT05920525
Study group	Role	What they receive
Electrical stimulation	Experimental	In this group of patients, retraction of upper anterior teeth will be done using backward traction, and the remodeling will be enhanced by very light electrical stimulation by a specific device. Receives: Device: Electrical stimulation
Traditional retraction of the front teeth	Active comparator	In this group of patients, traditional traction of the front teeth will be employed without any acceleration method. Receives: Procedure: Traditional retraction of the front upper teeth

What is being measured

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

Change in the perception of pain
Patients will be asked this question about their perception of pain. 'What is the degree of pain accompanying this moment?' Pain is assessed by asking the study participant to place a mark on a horizontal 100-mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0), whereas the right end refers to maximum (unimaginable) pain (VAS=100).
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the perception of discomfort
Patients will be asked this question about their perception of discomfort. 'What is the degree of discomfort that accompanies this moment?' Discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0), whereas the right end refers to maximum (unimaginable) discomfort (VAS=100).
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth

Secondary outcomes (9)

Change in the perception of burning
Patients will be asked this question about their perception of burning. 'Do you feel any burning in the upper anterior teeth area?' burning is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of burning being experienced. The left end of the line refers to no burning (VAS=0), whereas the right end refers to maximum (unimaginable) burning (VAS=100).
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the perception of swelling
Patients will be asked this question about their perception of swelling. 'Do you feel any Swelling in the upper anterior teeth area?' Swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of Swelling being experienced. The left end of the line refers to no Swelling (VAS=0), whereas the right end refers to maximum (unimaginable) Swelling (VAS=100).
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the chewing ability
Patients will be asked this question about their perception of chewing ability. 'what is the degree of chewing difficulties? ' difficulty in chewing is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulty in swallowing being experienced. The left end of the line refers to no difficulty (VAS=0), whereas the right end refers to the maximum difficulty in mastication.
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the speech ability
Patients will be asked this question about their perception of speech ability. ''what is the degree of speech difficulties?' Difficulty in speech is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulty in speech being experienced. The left end of the line refers to no difficulty (VAS=0), whereas the right end refers to maximum (unimaginable) difficulty (VAS=100).
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Analgesic consumption
Patients will be asked this question about "Analgesic Consumption". 'Did you need to take pain analgesics?' Analgesic Consumption is assessed by asking the study participant about taking analgesics using a two-point scale (1. Yes, or 2. No).
Measured: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Patients' satisfaction
Patients will be asked this question about satisfaction with orthodontic treatment.
'How satisfied are you with your orthodontic treatment?' Satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0), whereas the right end refers to maximum satisfaction (VAS=100).
Measured: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Ease of the procedure
Patients will be asked this question about the ease of the procedure. 'Was it getting used to the accelerating device? ' The procedure's easiness is assessed by asking the participant in the experimental group using a three-point scale (1. easy, 2. Medium, or 3. difficult).
Measured: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
The possibility of repeating the procedure
Patients will be asked this question about "The possibility of repeating the procedure.
'Would you accept to undergo this treatment again?' Patients in the experimental group will be asked about the possibility of repeating the procedure if they can give their decision again. The answer will be collected using a two-point scale (1. Yes, or 2. No).
Measured: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Recommendation of the procedure to a friend
Patients will be asked this question about the possibility of recommending the procedure to their friends.
'Would you recommend a friend to undergo this treatment?' Patients in the experimental group will be asked if they would recommend this procedure to a friend. The answer will be collected using a two-point scale (1. Yes, or 2. No).
Measured: Questionnaires will be filled at the end of the fifth month of the en-masse retraction

Timeline

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

15 Mar 202115 May 2023

First posted27 Jun 2023
Study start15 Mar 2021
Primary completion15 Sep 2022
Study completion15 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Class II Malocclusion, Division 1Studies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05920525
Sponsor's protocol ID: UDDS-Ortho-11-2023
Status last verified: Jun 2023
First submitted: 17 Jun 2023
Last updated: 27 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Roth PM, Thrash WJ. Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1986 Aug;90(2):132-8. doi: 10.1016/0889-5406(86)90045-4.
PubMed 3488674
Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.
PubMed 6243448
Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.
PubMed 37234453
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Class II Malocclusion, Division 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Patient-reported Outcome Measures (PROMs) During Accelerating the En-masse Retraction of Upper Anterior Teeth Using a Low-intensity Direct Electrical Current: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05920525
Acronym / sponsor ID: UDDS-Ortho-11-2023
Conditions: Class II Malocclusion, Division 1
Keywords: Retraction of upper anterior teeth, Electrical stimulation, Coil springs
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Mar 2021 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 15 May 2023 (actual)
First posted: 27 Jun 2023 (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.

A special removable electrical device will be used to provide electrical stimulation during the retraction phase.

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales.

Detailed description

The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales. 24 hours following the springs activation (T1), three days (T2), and one week (T3).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Electrical stimulation	Experimental	Device: Electrical stimulationIn this group of patients, retraction of upper anterior teeth will be done using backward traction, and the remodeling will be enhanced by very light electrical stimulation by a specific device.
Traditional retraction of the front teeth	Active comparator	Procedure: Traditional retraction of the front upper teethIn this group of patients, traditional traction of the front teeth will be employed without any acceleration method.

Who may qualify

Ages: 17 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

Adult healthy patients of both sexes
Age range: 17-25 years.
Class II Division 1 malocclusion:
The presence of all permanent upper teeth (regardless of third molars).
Good oral and periodontal health:

Key exclusion criteria (5 listed)

Patients with previous orthodontic treatment.
Patients with severe skeletal dysplasia in all three dimensions.
Patients suffer from systemic diseases or syndromes
Patients on medication for systemic disorders, pregnancy, or steroid therapy.
Patients showing any signs of active periodontal disease

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
Electrical stimulationA specific device will be used to stimulate the remodeling procedures in the alveolar bone.	Device	Electrical stimulation
Traditional retraction of the front upper teethThe retraction will be performed using coil springs which will help in moving the anterior teeth backward without the need to employ any additional procedure or device to accelerate this movement.	Procedure or surgery	Traditional retraction of the front teeth

Primary outcome

Change in the perception of pain
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Patients will be asked this question about their perception of pain. 'What is the degree of pain accompanying this moment?' Pain is assessed by asking the study participant to place a mark on a horizontal 100-mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0), whereas the right end refers to maximum (unimaginable) pain (VAS=100).
Change in the perception of discomfort
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Patients will be asked this question about their perception of discomfort. 'What is the degree of discomfort that accompanies this moment?' Discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0), whereas the right end refers to maximum (unimaginable) discomfort (VAS=100).

9 secondary outcomes

Change in the perception of burning
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the perception of swelling
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the chewing ability
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Change in the speech ability
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Analgesic consumption
Time frame: Questionnaires will be filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth
Patients' satisfaction
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Ease of the procedure
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
The possibility of repeating the procedure
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction
Recommendation of the procedure to a friend
Time frame: Questionnaires will be filled at the end of the fifth month of the en-masse retraction

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 27 Jun 2023.
Background: PubMed 3488674Roth PM, Thrash WJ. Effect of transcutaneous electrical nerve stimulation for controlling pain associated with orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1986 Aug;90(2):132-8. doi: 10.1016/0889-5406(86)90045-4.
Background: PubMed 6243448Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.
Background: PubMed 37234453Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.
Derived from this study: PubMed 38735912Shaadouh 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.
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.

Rashad Ibrahim Shaadouh, DDS principal investigator

Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electrical stimulation and Traditional retraction of the front upper teeth in people with Class II Malocclusion, Division 1, 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 13 inclusion and 5 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 27 Jun 2023. 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 filled at the following assessment times: at the 1st, 3rd, and 7th day of the first, second, and third months from the beginning of the en-masse retraction of upper anterior teeth). 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 NCT05920525, which also lists 4 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 27 Jun 2023.