Crowding, ToothNCT05250921

Evaluation of the Patient Experience With a Surgically-assisted Acceleration Method of Orthodontic Treatment

A study testing Corticision and Conventional fixed appliance in people with Crowding, Tooth, 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

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods. Read more about this study

Who is it for?: Ages 18 to 24 years
Conditions the study is for: Crowding, Tooth
What is being tested?: Corticision and Conventional fixed appliance
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteSyria
Study dates: 9 Mar 2019to 26 Aug 2020
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 18 to 24 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age range between 18 and 24 years
Completion of permanent dentition (except third molars)
Mild to moderate crowding (2-6 mm according to Little's index)
Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Who cannot join

Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
Patients had previous orthodontic treatments
Poor oral hygiene or concurrent periodontal disease

Trial locations and contacts

1 site in 1 country.

Syria1 site

University of Damascus
Damascus

Other trials in Syria

About this study

Official title: The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial

Researches used minimally invasive surgical methods like corticision, piezocesion, disicion, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods.

Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Read the detailed description

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusions.

Conditions: Crowding, Tooth
Being tested: Corticision, Conventional fixed appliance
Keywords: Corticision, Visual analog scale, Mild and moderate crowding, Surgical blade, Pain, Discomfort
Medical subject headings: Malocclusion, Lymphoma, Follicular, Pain

What participants receive

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

CorticisionProcedure or surgery
Corticision will be performed to enhance teeth alignment.
Conventional fixed applianceDevice
No surgical intervention is going to be applied to the patients in this group.

Study groups in NCT05250921
Study group	Role	What they receive
Corticision	Experimental	Corticision will be performed on the lower anterior teeth using a surgical blade and a hammer. Receives: Procedure: Corticision
Conventional method	Active comparator	A fixed appliance will be applied using conventional braces without any surgical procedure. Receives: Device: Conventional fixed appliance

What is being measured

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

Change in the levels of pain
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) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.
Measured: at 1, 7, 14 days following the onset of orthodontic treatment
Change in the levels of discomfort:
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) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.
Measured: at 1, 7, 14 days following the onset of orthodontic treatment
Change in the levels of swelling
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) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling.
Measured: at 1, 7, 14 days following the onset of orthodontic treatment
Change in the perception of mastication problems:
difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication are represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.
Measured: at 1, 7, 14 days following the onset of orthodontic treatment
Number of analgesic tables taken
The number of tablets used: Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took.
Measured: at seven days following the onset of orthodontic treatment

Secondary outcomes (4)

Satisfaction using VAS:
Definition: 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) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.
Measured: At the end of leveling and alignment
Satisfaction with the ease of the procedure
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 ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.
Measured: At the end of leveling and alignment
Satisfaction through acceptability of the procedure
Patients in corticision group were asked about possibility of repeating the procedure, and they answered using a two-point scale (1. Yes or 2. No).
Measured: At the end of leveling and alignment
Satisfaction through recommending the procedure
Recommendation to a friend: Patients in corticision group were asked about making recommendation to a friend, and they answered using a two-point scale (1. Yes or 2. No).
Measured: At the end of leveling and alignment

Timeline

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

9 Mar 201926 Aug 2020

First posted22 Feb 2022
Study start9 Mar 2019
Primary completion12 Jan 2020
Study completion26 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Crowding, ToothStudies 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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05250921
Sponsor's protocol ID: UDDS-Ortho-03-2022
Status last verified: Feb 2022
First submitted: 11 Feb 2022
Last updated: 22 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
PubMed 30991984
Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
PubMed 29853235
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
PubMed 27129491
Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.
PubMed 30370430
Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.
PubMed 28371882

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

Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth

All Crowding, Tooth trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05250921
Acronym / sponsor ID: UDDS-Ortho-03-2022
Conditions: Crowding, Tooth
Keywords: Corticision, Visual analog scale, Mild and moderate crowding, Surgical blade, Pain, Discomfort
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 9 Mar 2019 (actual)
Primary completion: 12 Jan 2020 (actual)
Study completion: 26 Aug 2020 (actual)
First posted: 22 Feb 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.

Detailed description

Study design

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

Arm	Type	Receives
Corticision	Experimental	Procedure: CorticisionCorticision will be performed on the lower anterior teeth using a surgical blade and a hammer.
Conventional method	Active comparator	Device: Conventional fixed applianceA fixed appliance will be applied using conventional braces without any surgical procedure.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age range between 18 and 24 years
Completion of permanent dentition (except third molars)
Mild to moderate crowding (2-6 mm according to Little's index)
Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Key exclusion criteria (4 listed)

Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
Patients had previous orthodontic treatments
Poor oral hygiene or concurrent 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
CorticisionCorticision will be performed to enhance teeth alignment.	Procedure or surgery	Corticision
Conventional fixed applianceNo surgical intervention is going to be applied to the patients in this group.	Device	Conventional method

Primary outcome

Change in the levels of pain
Time frame: at 1, 7, 14 days following the onset of orthodontic treatment
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) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.
Change in the levels of discomfort:
Time frame: at 1, 7, 14 days following the onset of orthodontic treatment
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) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.
Change in the levels of swelling
Time frame: at 1, 7, 14 days following the onset of orthodontic treatment
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) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling.
Change in the perception of mastication problems:
Time frame: at 1, 7, 14 days following the onset of orthodontic treatment
difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication are represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.
Number of analgesic tables taken
Time frame: at seven days following the onset of orthodontic treatment
The number of tablets used: Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took.

4 secondary outcomes

Satisfaction using VAS:
Time frame: At the end of leveling and alignment
Satisfaction with the ease of the procedure
Time frame: At the end of leveling and alignment
Satisfaction through acceptability of the procedure
Time frame: At the end of leveling and alignment
Satisfaction through recommending the procedure
Time frame: At the end of leveling and alignment

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 22 Feb 2022.
Background: PubMed 30991984Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Background: PubMed 29853235Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
Background: PubMed 27129491Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
Background: PubMed 30370430Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.
Background: PubMed 28371882Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.
Individual participant dataSharing planned: No

Related trials for Crowding, Tooth

Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth

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.

Mohamad Radwan Sirri, DDS MSc principal investigator

Department of orthodontics, Damascus University, Syria

Ahmad S Burhan, DDS MSc PhD study director

Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

Mohammad Y Hajeer, DDS MSc PhD study director

Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School

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

Questions about this trial

What is this clinical trial studying?

A study testing Corticision and Conventional fixed appliance in people with Crowding, Tooth, 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 4 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 22 Feb 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?

Change in the levels of pain (time frame: at 1, 7, 14 days following the onset of orthodontic treatment). The study lists 5 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 NCT05250921, which also lists 5 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 22 Feb 2022.