Class II Division 1 MalocclusionNCT04316403

Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction

A study testing Er:YAG laser in people with Class II Division 1 Malocclusion and Maxillary Prognathism, 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

Search all trials

Trial summary

Who is it for?: Ages 16 to 26 years
Conditions the study is for: Class II Division 1 Malocclusion, Maxillary Prognathism, Protrusion, Incisor
What is being tested?: Er:YAG laser
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteSyria
Study dates: 15 Feb 2015to 15 Sep 2017
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 26 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.
Permanent dentition with an age range from 16 to 24 years.
Healthy with no systemic conditions.
Adequate oral hygiene and healthy periodontal tissues
no previous orthodontic treatment
Absence of canine endodontic treatment.

Who cannot join

Bimaxillary dentoalveolar severe protrusion.
Previous orthodontic treatment.
Subject with psychological abnormalities.
Subject with systemic diseases.

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orthodontic Department, University of Hama Dental School
Hama, 12JO76WH

Other trials in Syria

About this study

Official title: Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial

Erbium lasers have been suggested to accomplish corticotomy without flap reflection due to their attractive advantages. The current trial aimed to evaluate the efficacy of laser-assisted flapless corticotomy in accelerating orthodontic tooth movement. The secondary aim was to evaluate the patients' responses to laser application. It was postulated that canine retraction after laser-assisted flapless corticotomy would be accomplished within a shorter period compared with the conventional canine retraction method, with no significant degree of pain and discomfort.

Read the detailed description

Comprehensive orthodontic treatment with fixed appliances usually takes more than 18 months in mild and severe cases. Prolonged treatment time can cause many adverse effects such as pain, discomfort, external root resorption, white spots and dental caries. Decreasing the treatment time for tooth movement has been the focus of both the clinicians and the patients. For the last few decades, investigators have recommended many treatment approaches intending to reduce overall treatment time such as low friction and self-ligating bracket systems, low-level laser irradiation, electrical currents, pharmacological approaches, local platelet-rich plasma (PRP) injection and surgical approaches like dentoalveolar distraction and selective alveolar decortication or corticotomy

Conditions: Class II Division 1 Malocclusion, Maxillary Prognathism, Protrusion, Incisor
Being tested: Er:YAG laser
Keywords: Tooth movement, Acceleration of tooth movement, Er:YAG laser-assisted corticotomy
Medical subject headings: Malocclusion, Angle Class II, Overbite

What participants receive

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

Er:YAG laserProcedure or surgery
This application was made before the onset of canine retraction in one side of the mouth

Study groups in NCT04316403
Study group	Role	What they receive
Laser-assisted corticotomy	Experimental	Er:YAG laser beam was used to perform several perforations to the alveolar bone around the canine in one side of the mouth hoping that would accelerate canine retraction Receives: Procedure: Er:YAG laser
Traditional treatment	No intervention	Canines in this group were retracted by the conventional manner.

What is being measured

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

Change in the canine retraction rate
The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.
Measured: 10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application

Secondary outcomes (1)

Change in the levels of pain and discomfort
A questionnaire was administered at the 1st, 3rd, 5th and 7th day after laser application. The questionnaire contained 5 questions (using 4-point Likert ordinal scales) to collect patients' responses on the following questions:
Question 1: Do you feel pain during eating? Question 2: Do you feel pain during the day? Question 3: Do you feel pain that can awaken you during the night? Question 4: Do you feel swollen on the surgical side?
The possible answers were:
1. No 2.Mild 3.Moderate 4. Severe For the first four questions, the higher the score, the worse the feeling was.
Question 5: Which one of the following has caused more discomfort to you?
1. Extraction of premolars 2. Laser application 3.Both
Measured: at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application

Timeline

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

15 Feb 201515 Sep 2017

First posted20 Mar 2020
Study start15 Feb 2015
Primary completion15 Jun 2017
Study completion15 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Class II Division 1 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: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04316403
Sponsor's protocol ID: UDDS-Ortho-01-2020
Status last verified: Mar 2020
First submitted: 18 Mar 2020
Last updated: 24 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fisher MA, Wenger RM, Hans MG. Pretreatment characteristics associated with orthodontic treatment duration. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):178-86. doi: 10.1016/j.ajodo.2008.09.028.
PubMed 20152672
Segal GR, Schiffman PH, Tuncay OC. Meta analysis of the treatment-related factors of external apical root resorption. Orthod Craniofac Res. 2004 May;7(2):71-8. doi: 10.1111/j.1601-6343.2004.00286.x.
PubMed 15180086
Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015.
PubMed 24680026
Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
PubMed 27484605
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 27869476
Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61.
PubMed 2133892
Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.
PubMed 33876339

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

Recruiting
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
CLASS II DIVISION 1 MALOCCLUSION
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LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Recruiting
EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
CLASS II DIVISION 1 MALOCCLUSION
Not yet recruiting
Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
Class II Malocclusion, Class II Malocclusion, Division 1
Not yet recruiting
The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
CLASS II DIVISION 1 MALOCCLUSION, Class II Malocclusion

All Class II Division 1 Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of Laser-assisted Flapless Corticotomy in Accelerating Canine Retraction: A Split-mouth Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT04316403
Acronym / sponsor ID: UDDS-Ortho-01-2020
Conditions: Class II Division 1 Malocclusion, Maxillary Prognathism, Protrusion, Incisor
Keywords: Tooth movement, Acceleration of tooth movement, Er:YAG laser-assisted corticotomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Feb 2015 (actual)
Primary completion: 15 Jun 2017 (actual)
Study completion: 15 Sep 2017 (actual)
First posted: 20 Mar 2020 (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.

Detailed description

Study design

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

Arm	Type	Receives
Laser-assisted corticotomy	Experimental	Procedure: Er:YAG laserEr:YAG laser beam was used to perform several perforations to the alveolar bone around the canine in one side of the mouth hoping that would accelerate canine retraction
Traditional treatment	No intervention	–Canines in this group were retracted by the conventional manner.

Who may qualify

Ages: 16 to 26 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Class II division 1 patients requiring orthodontic treatment with fixed appliances and a need for upper first-premolar extraction using a two-step retraction technique.
Permanent dentition with an age range from 16 to 24 years.
Healthy with no systemic conditions.
Adequate oral hygiene and healthy periodontal tissues
no previous orthodontic treatment

Key exclusion criteria (4 listed)

Bimaxillary dentoalveolar severe protrusion.
Previous orthodontic treatment.
Subject with psychological abnormalities.
Subject with systemic diseases.

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
Er:YAG laserThis application was made before the onset of canine retraction in one side of the mouth	Procedure or surgery	Laser-assisted corticotomy

Primary outcome

Change in the canine retraction rate
Time frame: 10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application
The distance between the first molar labial hook and the canine bracket hook was recorded using Digital Boely gauge and then this distance was divided by the time that passed between two assessment points.

1 secondary outcome

Change in the levels of pain and discomfort
Time frame: at the 1st day following laser application (10 minutes) and at the 3rd, 5th and 7th days following laser application

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 24 Mar 2020.
Background: PubMed 20152672Fisher MA, Wenger RM, Hans MG. Pretreatment characteristics associated with orthodontic treatment duration. Am J Orthod Dentofacial Orthop. 2010 Feb;137(2):178-86. doi: 10.1016/j.ajodo.2008.09.028.
Background: PubMed 15180086Segal GR, Schiffman PH, Tuncay OC. Meta analysis of the treatment-related factors of external apical root resorption. Orthod Craniofac Res. 2004 May;7(2):71-8. doi: 10.1111/j.1601-6343.2004.00286.x.
Background: PubMed 24680026Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015.
Background: PubMed 27484605Hassan SE, Hajeer MY, Alali OH, Kaddah AS. The Effect of Using Self-ligating Brackets on Maxillary Canine Retraction: A Split-mouth Design Randomized Controlled Trial. J Contemp Dent Pract. 2016 Jun 1;17(6):496-503. doi: 10.5005/jp-journals-10024-1879.
Background: PubMed 27869476AlSayed 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.
Background: PubMed 2133892Hashimoto H. Effect of micro-pulsed electricity on experimental tooth movement. Nihon Kyosei Shika Gakkai Zasshi. 1990 Aug;49(4):352-61.
Derived from this study: PubMed 33876339Jaber ST, Al-Sabbagh R, Hajeer MY. Evaluation of the efficacy of laser-assisted flapless corticotomy in accelerating canine retraction: a split-mouth randomized controlled clinical trial. Oral Maxillofac Surg. 2022 Mar;26(1):81-89. doi: 10.1007/s10006-021-00963-x. Epub 2021 Apr 20.
Individual participant dataSharing planned: No

Related trials for Class II Division 1 Malocclusion

Recruiting
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
CLASS II DIVISION 1 MALOCCLUSION
Recruiting
LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
Malocclusion, Angle Class II, Division 1, Bimaxillary Protrusion
Recruiting
EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
CLASS II DIVISION 1 MALOCCLUSION
Not yet recruiting
Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
Class II Malocclusion, Class II Malocclusion, Division 1
Not yet recruiting
The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
CLASS II DIVISION 1 MALOCCLUSION, Class II Malocclusion

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.

Samer T Jaber, DDS MSc principal investigator

PhD student, Orthodontics Department, University of Damascus Dental School

Rabab Al-sabbagh, DDS MSc PhD study chair

Professor of Orthodontics, University of Hama, Hama, 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 Er:YAG laser in people with Class II Division 1 Malocclusion and Maxillary Prognathism, 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 6 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 24 Mar 2020. 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 canine retraction rate (time frame: 10 minutes after laser application, one, two, four, 8 and 12 weeks after laser application). 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 NCT04316403, which also lists 7 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 24 Mar 2020.