Class II MalocclusionNCT05302076
Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement
A study testing Low-intensity electrical current (LIEC) and Traditional fixed orthodontic appliance in people with Class II Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
Thirty two patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be divided randomly into two groups: electrical group and control group. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Low-intensity electrical current (LIEC) and Traditional fixed orthodontic appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSyria
- Study dates
- 23 Aug 2019to 5 Dec 2021
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult healthy patients, Male and female, Age range: 15-27 years.
- Class II Division 1 malocclusion :
- Mild / moderate skeletal Class II (sagittal discrepancy angle ≤7)
- Overjet ≤10
- Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles : mandibular/cranial base angle, maxillary/mandibular plane angle and facial axis angle)
- Mild to moderate crowding ≤ 4
Show all 13Show fewer
- Permanent occlusion.
- Existence of all the upper teeth (except 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
- Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm
- radiographic evidence of bone loss
Show all 9Show fewer
- Gingival index > 1
- Plaque index > 1
- Patient had previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effect of Low-intensity Electrical Current (LIEC) in Accelerating the En-masse Retraction of the Maxillary Anterior Teeth and the Associated Skeletal, Dental and Periodontal Changes : A Randomized Controlled Clinical Trial
Thirty two patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be divided randomly into two groups: electrical group and control group. In each group, en-masse retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 250 g of force per side, Mini-implants will be used as an anchor unit.
The overall retraction duration will be calculated. The skeletal, dental and soft tissue changes will be detected using panoramic and lateral cephalometric radiographs which will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth.
Read the detailed description
Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. They will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted.
A removable device containing a small electrical circuit will be applied to each patient to supply the required electric current.
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.
(250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks. Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained.
The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination.
Panoramic and lateral cephalometric radiographs will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth, to assess the skeletal, dental and soft tissue changes.
Periodontal health will be assessed at the beginning of orthodontic treatment, before and after en-masse retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, probing depth and gingival recession.
- Conditions
- Class II Malocclusion
- Being tested
- Low-intensity electrical current (LIEC), Traditional fixed orthodontic appliance
- Keywords
- En-masse retraction, Acceleration, Low-intensity electric current
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity electrical current (LIEC)Device
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.
Traditional fixed orthodontic applianceDevice
The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted. (250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction.
| Study group | Role | What they receive |
|---|---|---|
| electric current | Experimental | Electric current will be applied in this group of patients using removable device. Receives: Device: Low-intensity electrical current (LIEC) |
| Traditional treatment | Active comparator | No acceleration method will be performed in this group. Receives: Device: Traditional fixed orthodontic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of en-masse retraction of anterior teeth
Assessment will be performed by calculating the time required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
Measured: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.
Change in the SN-U1 angle
This angle the represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Change in the SNA angle
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Change in the MM angle
This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Secondary outcomes (8)
Change in the Nasolabial angle
This angle the represents the relationship of the upper lip with nose in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Change in the Li-E Line
This measurement represents the relationship between the upper lip and the Ricketts line in cephalometric analysis. Lateral cephalograms will be taken and this variable will be measured in mm.
Measured: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Change in Root Length
The root length will be measured for each root of six upper anterior teeth using panorama imaging, the change will be calculated between before and after images in mm.
Measured: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Plaque index
The plaque index will be used to assess the status of the oral hygiene in these patients.
Measured: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Gingival Index
The Gingival index will be used to assess the status of the gingival tissues around the teeth.
Measured: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Bleeding Index
The Bleeding index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth.
Measured: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Probing Depth
This will be measured in millimeters from the gingival margin to the bottom of the sulcus/pocket around the six anterior teeth.
Measured: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Gingival Recession
This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.
Measured: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start23 Aug 2019
- Primary completion12 Feb 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Class II 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rashad Ibrahem Shaadouh, DDS, Principal investigator, Department of orthodontics, Damascus University, SyriaMohammad Y Hajeer, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, SyriaGhiath Mahmoud, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302076
- Sponsor's protocol ID
- UDDS-Ortho-05-2022
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 6243448Spadari GS, Zaniboni E, Vedovello SA, Santamaria MP, do Amaral ME, Dos Santos GM, Esquisatto MA, Mendonca FA, Santamaria M Jr. Electrical stimulation enhances tissue reorganization during orthodontic tooth movement in rats. Clin Oral Investig. 2017 Jan;21(1):111-120. doi: 10.1007/s00784-016-1759-6. Epub 2016 Feb 26.
PubMed 26917494Zaniboni E, Bagne L, Camargo T, do Amaral MEC, Felonato M, de Andrade TAM, Dos Santos GMT, Caetano GF, Esquisatto MAM, Santamaria M Jr, Mendonca FAS. Do electrical current and laser therapies improve bone remodeling during an orthodontic treatment with corticotomy? Clin Oral Investig. 2019 Nov;23(11):4083-4097. doi: 10.1007/s00784-019-02845-9. Epub 2019 Feb 15.
PubMed 30771000Chaudhari SD, Sharma KK, Marchetto JJ, Hydren JR, Burton BM, Moreno AP. Modulating OPG and TGF-beta1 mRNA expression via bioelectrical stimulation. Bone Rep. 2021 Oct 9;15:101141. doi: 10.1016/j.bonr.2021.101141. eCollection 2021 Dec.
PubMed 34692946Gkantidis N, Mistakidis I, Kouskoura T, Pandis N. Effectiveness of non-conventional methods for accelerated orthodontic tooth movement: a systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1300-19. doi: 10.1016/j.jdent.2014.07.013. Epub 2014 Jul 27.
PubMed 25072362Masella RS, Meister M. Current concepts in the biology of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):458-68. doi: 10.1016/j.ajodo.2005.12.013.
PubMed 16627170
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Low-intensity Electrical Current (LIEC) in Accelerating the En-masse Retraction of the Maxillary Anterior Teeth and the Associated Skeletal, Dental and Periodontal Changes : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05302076
- Acronym / sponsor ID
- UDDS-Ortho-05-2022
- Conditions
- Class II Malocclusion
- Keywords
- En-masse retraction, Acceleration, Low-intensity electric current
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 31 Mar 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.
Thirty two patients requiring extraction of maxillary first premolars and en-masse retraction of upper anterior teeth will participate in the study. They will be divided randomly into two groups: electrical group and control group. In each group, en-masse retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 250 g of force per side, Mini-implants will be used as an anchor unit.
The overall retraction duration will be calculated. The skeletal, dental and soft tissue changes will be detected using panoramic and lateral cephalometric radiographs which will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth.
Detailed description
Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. They will be inserted between the maxillary second premolar and first molar at approximately 8-10 mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted.
A removable device containing a small electrical circuit will be applied to each patient to supply the required electric current.
Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth.
(250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks. Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained.
The duration of retraction will be calculated by calculating the time required to achieve complete retraction of the upper anterior teeth through clinical examination.
Panoramic and lateral cephalometric radiographs will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth, to assess the skeletal, dental and soft tissue changes.
Periodontal health will be assessed at the beginning of orthodontic treatment, before and after en-masse retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, probing depth and gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electric current | Experimental | Device: Low-intensity electrical current (LIEC)Electric current will be applied in this group of patients using removable device. |
| Traditional treatment | Active comparator | Device: Traditional fixed orthodontic applianceNo acceleration method will be performed in this group. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Adult healthy patients, Male and female, Age range: 15-27 years.
- Class II Division 1 malocclusion :
- Permanent occlusion.
- Existence of all the upper teeth (except third molars).
- Good oral and periodontal health:
Key exclusion criteria (9 listed)
- Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Patient had previous orthodontic 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 |
|---|---|---|
| Low-intensity electrical current (LIEC)Each patient in the electrical group will be asked to wear a removable device containing a small electrical circuit that will supply the required electric current for five hours a day until the completion the retraction of the upper anterior teeth. | Device | electric current |
| Traditional fixed orthodontic applianceThe maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the canines will be inserted. (250-300) g force will be applied on each side using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. | Device | Traditional treatment |
Primary outcome
Duration of en-masse retraction of anterior teeth
Time frame: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.
Assessment will be performed by calculating the time required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
Change in the SN-U1 angle
Time frame: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the relationship of the upper anterior teeth with SN in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the SNA angle
Time frame: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the MM angle
Time frame: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
8 secondary outcomes
Change in the Nasolabial angle
Time frame: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Change in the Li-E Line
Time frame: : The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
Change in Root Length
Time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Plaque index
Time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Gingival Index
Time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Bleeding Index
Time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Probing Depth
Time frame: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
Change in the Gingival Recession
Time frame: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
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 31 Mar 2022.
- 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 26917494Spadari GS, Zaniboni E, Vedovello SA, Santamaria MP, do Amaral ME, Dos Santos GM, Esquisatto MA, Mendonca FA, Santamaria M Jr. Electrical stimulation enhances tissue reorganization during orthodontic tooth movement in rats. Clin Oral Investig. 2017 Jan;21(1):111-120. doi: 10.1007/s00784-016-1759-6. Epub 2016 Feb 26.
- Background: PubMed 30771000Zaniboni E, Bagne L, Camargo T, do Amaral MEC, Felonato M, de Andrade TAM, Dos Santos GMT, Caetano GF, Esquisatto MAM, Santamaria M Jr, Mendonca FAS. Do electrical current and laser therapies improve bone remodeling during an orthodontic treatment with corticotomy? Clin Oral Investig. 2019 Nov;23(11):4083-4097. doi: 10.1007/s00784-019-02845-9. Epub 2019 Feb 15.
- Background: PubMed 34692946Chaudhari SD, Sharma KK, Marchetto JJ, Hydren JR, Burton BM, Moreno AP. Modulating OPG and TGF-beta1 mRNA expression via bioelectrical stimulation. Bone Rep. 2021 Oct 9;15:101141. doi: 10.1016/j.bonr.2021.101141. eCollection 2021 Dec.
- Background: PubMed 25072362Gkantidis N, Mistakidis I, Kouskoura T, Pandis N. Effectiveness of non-conventional methods for accelerated orthodontic tooth movement: a systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1300-19. doi: 10.1016/j.jdent.2014.07.013. Epub 2014 Jul 27.
- Background: PubMed 16627170Masella RS, Meister M. Current concepts in the biology of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):458-68. doi: 10.1016/j.ajodo.2005.12.013.
- Individual participant dataSharing planned: No
Related trials for Class II Malocclusion
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
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
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 Ibrahem Shaadouh, DDS principal investigator
Department of orthodontics, Damascus University, Syria
Mohammad Y Hajeer, DDS,MSc,PhD study director
Department of orthodontics, Damascus University, Syria
Ghiath Mahmoud, DDS,MSc,PhD study director
Department of orthodontics, Damascus University, 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 Low-intensity electrical current (LIEC) and Traditional fixed orthodontic appliance in people with Class II 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 13 inclusion and 9 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 31 Mar 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 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?
Duration of en-masse retraction of anterior teeth (time frame: The months required to complete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.). The study lists 4 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 NCT05302076, 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 31 Mar 2022.