Tooth MovementNCT06526871
Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .
A study testing Low-Level Laser acceleration and clear aligner therapy in people with Tooth Movement, run by Huda Abdelhakim at 1 site in Egypt.
Trial summary
The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners Read more about this study
- Who is it for?
- Ages 16 to 23 years, women only
- Conditions the study is for
- Tooth Movement
- What is being tested?
- Low-Level Laser acceleration and clear aligner therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2022to 3 Jul 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 16 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- A well-behaved, compliant, and motivated patient.
- Patients from 16 to 23 years old .
- Patients with mild to moderate anterior lower crowding.
- Full complement of teeth (except for wisdom teeth).
- Class I Angle malocclusion .
Who cannot join
- Patients with missed anterior teeth .
- Class II or III Malocclusion (dental or skeletal ) .
- Any systemic diseases that may interfere with assigned treatment plan .
- Periodontal affection especially at lower anterior teeth .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration (Randomized Control Study) .
The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners
Read the detailed description
This study will employ a two-arm parallel randomized clinical trial design with an allocation ratio of 1:1. The study will include participants aged 16 to 23 years with mild to moderate anterior lower crowding and Class I Angle malocclusion, presenting with a full set of teeth excluding wisdom teeth. Eligible participants will be randomly assigned to either the intervention group, receiving LLLT in addition to clear aligner therapy, or the control group, receiving clear aligner therapy alone.
Intervention:
The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.
- Conditions
- Tooth Movement
- Being tested
- Low-Level Laser acceleration, clear aligner therapy
- Keywords
- Aligner, Crowding, Laser
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser accelerationProcedure or surgery
This intervention involves the application of Low-Level Laser Therapy (LLLT) using the Epic X device for patients undergoing orthodontic treatment. The protocol is designed to assess the effects of LLLT on pain reduction and treatment efficacy during the initial leveling and alignment phase of orthodontic therapy using clear aligners .
clear aligner therapyProcedure or surgery
Clear aligner therapy involves using a series of custom-made, clear plastic aligners to gradually move teeth into their desired positions. These aligners are worn over the teeth and are typically changed every week as the teeth gradually shift. The treatment process starts with a digital scan or impression of the teeth, which is used to create a 3D model. This model helps in planning the precise movements needed to achieve proper alignment. Throughout the treatment, patients visit their orthodontist periodically to monitor progress and receive new sets of aligners. Clear aligners are popular for their aesthetic appeal and the convenience they offer compared to traditional braces.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | ten patients treated with removable clear aligner Receives: Procedure: clear aligner therapy |
| Experimental group | Experimental | ten patients treated with removable clear aligner with application of Low-Level-Laser Receives: Procedure: Low-Level Laser acceleration; Procedure: clear aligner therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Little irregularity index
The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement.
Measured: through study completion, an average of 6 months
Secondary outcomes (7)
• Treatment time
The duration of orthodontic treatment, including active treatment phases such as wearing aligners or undergoing procedures like interproximal reduction, is crucially monitored. This active treatment time is distinct from overall treatment duration, which encompasses intervals such as retention phases or breaks between aligner changes.
Measured: through study completion, an average of 6 months
• Number of aligners
The number of aligners measurement involves determining the total quantity of clear aligners required for a patient's orthodontic treatment.
Measured: through study completion, an average of 6 months
• Patient comfort and satisfaction
Patient comfort and satisfaction were evaluated using standardized scales, including Visual Analog Scales (VAS) , to assess pain levels, oral discomfort, and overall treatment experience.
Measured: through study completion, an average of 6 months
• Refinement rate
The refinement rate in orthodontics refers to the frequency and extent of adjustments made to aligners or appliances during treatment to achieve optimal tooth alignment. It is typically measured by assessing the need for additional aligners,
Measured: through study completion, an average of 6 months
• Digital cast accuracy
Digital cast accuracy was assessed using 3D surface comparison methods, comparing intraoral scans with traditional plaster models.
Measured: through study completion, an average of 6 months
• Tooth movement accuracy
This process involved aligning and overlaying 3D models to assess the extent and direction of tooth displacement over time.
Measured: through study completion, an average of 6 months
• Software predictability
3D models were superimposed to analyze the accuracy of predicted tooth movements compared to actual outcomes.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start25 Oct 2022
- Primary completion2 Jun 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Tooth MovementStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huda Abdelhakim
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Huda Abdelhakim, Faculty of Dental Medicine for Girls
- Investigators
- Samir A Ibrahim, professor, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526871
- Sponsor's protocol ID
- ORTHO-109-2-K
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Das PJ, Dkhar W, Pradhan A. An Evaluation of Dental Crowding in Relation to the Mesiodistal Crown Widths and Arch Dimensions in Southern Indian Population. J Clin Diagn Res. 2017 Sep;11(9):TC10-TC13. doi: 10.7860/JCDR/2017/29642.10554. Epub 2017 Sep 1.
PubMed 29207804Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.
PubMed 35663697Knosel M, Nuser C, Jung K, Helms HJ, Engelke W, Sandoval P. Interaction between deglutition, tongue posture, and malocclusion: A comparison of intraoral compartment formation in subjects with neutral occlusion or different types of malocclusion. Angle Orthod. 2016 Sep;86(5):697-705. doi: 10.2319/101615-699.1. Epub 2016 Feb 19.
PubMed 26894981Tamer I, Oztas E, Marsan G. Orthodontic Treatment with Clear Aligners and The Scientific Reality Behind Their Marketing: A Literature Review. Turk J Orthod. 2019 Dec 1;32(4):241-246. doi: 10.5152/TurkJOrthod.2019.18083. eCollection 2019 Dec.
PubMed 32110470Hennessy J, Garvey T, Al-Awadhi EA. A randomized clinical trial comparing mandibular incisor proclination produced by fixed labial appliances and clear aligners. Angle Orthod. 2016 Sep;86(5):706-12. doi: 10.2319/101415-686.1.
PubMed 27571371Baghizadeh Fini M, Olyaee P, Homayouni A. The Effect of Low-Level Laser Therapy on the Acceleration of Orthodontic Tooth Movement. J Lasers Med Sci. 2020 Spring;11(2):204-211. doi: 10.34172/jlms.2020.34. Epub 2020 Mar 15.
PubMed 32273964Sharma R, Drummond R, Wiltshire W, Schroth R, Lekic M, Bertone M, Tate R. Quality of life in an adolescent orthodontic population. Angle Orthod. 2021 Nov 1;91(6):718-724. doi: 10.2319/062820-592.1.
PubMed 34260709Ghaffar YKA, El Sharaby FA, Negm IM. Effect of low-level laser therapy on the time needed for leveling and alignment of mandibular anterior crowding. Angle Orthod. 2022 Jul 1;92(4):478-486. doi: 10.2319/102721-795.1.
PubMed 35344012Soares Bonato RC, Abel Mapengo MA, de Azevedo-Silva LJ, Janson G, de Carvalho Sales-Peres SH. Tooth movement, orofacial pain, and leptin, interleukin-1beta, and tumor necrosis factor-alpha levels in obese adolescents. Angle Orthod. 2022 Jan 1;92(1):95-100. doi: 10.2319/011321-44.1.
PubMed 34338736Bakdach WMM, Hadad R. Effectiveness of low-level laser therapy in accelerating the orthodontic tooth movement: A systematic review and meta-analysis. Dent Med Probl. 2020 Jan-Mar;57(1):73-94. doi: 10.17219/dmp/112446.
PubMed 32314880Cossetin E, Janson G, de Carvalho MG, de Carvalho RA, Henriques JF, Garib D. Influence of low-level laser on bone remodeling during induced tooth movement in rats. Angle Orthod. 2013 Nov;83(6):1015-21. doi: 10.2319/100812-789.1. Epub 2013 May 14.
PubMed 23672280Guram G, Reddy RK, Dharamsi AM, Syed Ismail PM, Mishra S, Prakashkumar MD. Evaluation of Low-Level Laser Therapy on Orthodontic Tooth Movement: A Randomized Control Study. Contemp Clin Dent. 2018 Jan-Mar;9(1):105-109. doi: 10.4103/ccd.ccd_864_17.
PubMed 2959959413. Cokakoglu S. , Aydoğan F. Aydın B. low level laser therapy in orthodontics . Meandros Med Dent J.2018;19:99-105 .
AlSayed Hasan MMA, Sultan K, Hamadah O. Low-level laser therapy effectiveness in accelerating orthodontic tooth movement: A randomized controlled clinical trial. Angle Orthod. 2017 Jul;87(4):499-504. doi: 10.2319/062716-503.1. Epub 2016 Nov 21.
PubMed 2786947615. Ponciano F. A. S. , Gutiérrez-Rojo M. F. , Gutiérrez-Rojo J. F. .Crowding severity associated with dental mass . Revista Mexicana de Ortodoncia .2016;4:165-8 .
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration (Randomized Control Study) .
- ClinicalTrials.gov ID
- NCT06526871
- Acronym / sponsor ID
- ORTHO-109-2-K
- Conditions
- Tooth Movement
- Keywords
- Aligner, Crowding, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Huda AbdelhakimOther government
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 30 Jul 2024 (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.
The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners
Detailed description
This study will employ a two-arm parallel randomized clinical trial design with an allocation ratio of 1:1. The study will include participants aged 16 to 23 years with mild to moderate anterior lower crowding and Class I Angle malocclusion, presenting with a full set of teeth excluding wisdom teeth. Eligible participants will be randomly assigned to either the intervention group, receiving LLLT in addition to clear aligner therapy, or the control group, receiving clear aligner therapy alone.
Intervention:
The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: clear aligner therapyten patients treated with removable clear aligner |
| Experimental group | Experimental | Procedure: Low-Level Laser acceleration, Procedure: clear aligner therapyten patients treated with removable clear aligner with application of Low-Level-Laser |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- A well-behaved, compliant, and motivated patient.
- Patients from 16 to 23 years old .
- Patients with mild to moderate anterior lower crowding.
- Full complement of teeth (except for wisdom teeth).
- Class I Angle malocclusion .
Key exclusion criteria (4 listed)
- Patients with missed anterior teeth .
- Class II or III Malocclusion (dental or skeletal ) .
- Any systemic diseases that may interfere with assigned treatment plan .
- Periodontal affection especially at lower anterior teeth .
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-Level Laser accelerationThis intervention involves the application of Low-Level Laser Therapy (LLLT) using the Epic X device for patients undergoing orthodontic treatment. The protocol is designed to assess the effects of LLLT on pain reduction and treatment efficacy during the initial leveling and alignment phase of orthodontic therapy using clear aligners . | Procedure or surgery | Experimental group |
| clear aligner therapyClear aligner therapy involves using a series of custom-made, clear plastic aligners to gradually move teeth into their desired positions. These aligners are worn over the teeth and are typically changed every week as the teeth gradually shift. The treatment process starts with a digital scan or impression of the teeth, which is used to create a 3D model. This model helps in planning the precise movements needed to achieve proper alignment. Throughout the treatment, patients visit their orthodontist periodically to monitor progress and receive new sets of aligners. Clear aligners are popular for their aesthetic appeal and the convenience they offer compared to traditional braces. | Procedure or surgery | Experimental group, control group |
Primary outcome
• Little irregularity index
Time frame: through study completion, an average of 6 months
The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement.
7 secondary outcomes
• Treatment time
Time frame: through study completion, an average of 6 months
• Number of aligners
Time frame: through study completion, an average of 6 months
• Patient comfort and satisfaction
Time frame: through study completion, an average of 6 months
• Refinement rate
Time frame: through study completion, an average of 6 months
• Digital cast accuracy
Time frame: through study completion, an average of 6 months
• Tooth movement accuracy
Time frame: through study completion, an average of 6 months
• Software predictability
Time frame: through study completion, an average of 6 months
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 30 Jul 2024.
- Background: PubMed 29207804Das PJ, Dkhar W, Pradhan A. An Evaluation of Dental Crowding in Relation to the Mesiodistal Crown Widths and Arch Dimensions in Southern Indian Population. J Clin Diagn Res. 2017 Sep;11(9):TC10-TC13. doi: 10.7860/JCDR/2017/29642.10554. Epub 2017 Sep 1.
- Background: PubMed 35663697Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.
- Background: PubMed 26894981Knosel M, Nuser C, Jung K, Helms HJ, Engelke W, Sandoval P. Interaction between deglutition, tongue posture, and malocclusion: A comparison of intraoral compartment formation in subjects with neutral occlusion or different types of malocclusion. Angle Orthod. 2016 Sep;86(5):697-705. doi: 10.2319/101615-699.1. Epub 2016 Feb 19.
- Background: PubMed 32110470Tamer I, Oztas E, Marsan G. Orthodontic Treatment with Clear Aligners and The Scientific Reality Behind Their Marketing: A Literature Review. Turk J Orthod. 2019 Dec 1;32(4):241-246. doi: 10.5152/TurkJOrthod.2019.18083. eCollection 2019 Dec.
- Background: PubMed 27571371Hennessy J, Garvey T, Al-Awadhi EA. A randomized clinical trial comparing mandibular incisor proclination produced by fixed labial appliances and clear aligners. Angle Orthod. 2016 Sep;86(5):706-12. doi: 10.2319/101415-686.1.
- Background: PubMed 32273964Baghizadeh Fini M, Olyaee P, Homayouni A. The Effect of Low-Level Laser Therapy on the Acceleration of Orthodontic Tooth Movement. J Lasers Med Sci. 2020 Spring;11(2):204-211. doi: 10.34172/jlms.2020.34. Epub 2020 Mar 15.
- Background: PubMed 34260709Sharma R, Drummond R, Wiltshire W, Schroth R, Lekic M, Bertone M, Tate R. Quality of life in an adolescent orthodontic population. Angle Orthod. 2021 Nov 1;91(6):718-724. doi: 10.2319/062820-592.1.
- Background: PubMed 35344012Ghaffar YKA, El Sharaby FA, Negm IM. Effect of low-level laser therapy on the time needed for leveling and alignment of mandibular anterior crowding. Angle Orthod. 2022 Jul 1;92(4):478-486. doi: 10.2319/102721-795.1.
- Background: PubMed 34338736Soares Bonato RC, Abel Mapengo MA, de Azevedo-Silva LJ, Janson G, de Carvalho Sales-Peres SH. Tooth movement, orofacial pain, and leptin, interleukin-1beta, and tumor necrosis factor-alpha levels in obese adolescents. Angle Orthod. 2022 Jan 1;92(1):95-100. doi: 10.2319/011321-44.1.
- Background: PubMed 32314880Bakdach WMM, Hadad R. Effectiveness of low-level laser therapy in accelerating the orthodontic tooth movement: A systematic review and meta-analysis. Dent Med Probl. 2020 Jan-Mar;57(1):73-94. doi: 10.17219/dmp/112446.
- Background: PubMed 23672280Cossetin E, Janson G, de Carvalho MG, de Carvalho RA, Henriques JF, Garib D. Influence of low-level laser on bone remodeling during induced tooth movement in rats. Angle Orthod. 2013 Nov;83(6):1015-21. doi: 10.2319/100812-789.1. Epub 2013 May 14.
- Background: PubMed 29599594Guram G, Reddy RK, Dharamsi AM, Syed Ismail PM, Mishra S, Prakashkumar MD. Evaluation of Low-Level Laser Therapy on Orthodontic Tooth Movement: A Randomized Control Study. Contemp Clin Dent. 2018 Jan-Mar;9(1):105-109. doi: 10.4103/ccd.ccd_864_17.
- 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.
Samir A Ibrahim, professor principal investigator
Al-Azhar 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 Low-Level Laser acceleration and clear aligner therapy in people with Tooth Movement, run by Huda Abdelhakim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 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 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
• Little irregularity index (time frame: through study completion, an average of 6 months). 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 NCT06526871, which also lists 16 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 30 Jul 2024.