Malocclusion, Angle Class INCT02549950
Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement
A study testing Peizocorticision and Conventional Orthodontic Mechanics in people with Malocclusion, Angle Class I and Malocclusion; Angle Class II Division 1, run by AL Yousef at 1 site in Saudi Arabia.
Trial summary
The purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class I, Malocclusion; Angle Class II Division 1
- What is being tested?
- Peizocorticision and Conventional Orthodontic Mechanics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2015to Jul 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Voluntary participation of patients only
- Able to follow instruction, able to understand the consent form and sign it.
- Adult Female and Male Saudi patients 15-35 y.o
- Subjects who are none smokers
- Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
- Subjects with good periodontal and gingival health: Gingival Index GI≤ 1
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- Subjects with a none gummy smile,
- Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings
- Subjects without root anomalies
- Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion
Who cannot join
- Subjects younger than 15 y.o
- Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
- Subjects who are medically classified as ASA-II, III
- Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
- Subjects who are pregnant
- Subjects who are smokers
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- Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma
- Subjects with unhealthy or compromised periodontium
- Subjects with a gummy smile
- Subjects with inadequately treated endodontic and dental fillings problems
- Subjects with previous root resorption or dental developmental anomalies
- Subjects who had previous orthodontic treatment
- Subjects with TMJ signs and symptoms; Mandibular functional shift
- Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm
- Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.
- Subjects will be excluded if any of mini-screws failed during treatment
- Subjects who become medically unfit during course of trial
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
National Guard Hospital
Riyadh, 11426
SALLY K AL-YOUSEF, 00966118011111 ext. 14036, alyousefsa@ngha.med.sa
About this study
Official title: Efficiency and Efficacy of Peizo-Coticision in Reducing Orthodontic Treatment Time: Randomized Clinical Trial
The purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time.
Read the detailed description
1 Aim of the study- Part I:
This prospective controlled clinical trial (CCT), Split Mouth Design is conducted to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of canine teeth in class II div 1 subjects.
Specific aim- Part I:
A- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved canines
B- To compare length of treatment of both approaches.
2- Objectives of the Study Part II:
This prospective randomized controlled clinical trial (RCT) is designed to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of anterior teeth in class II div 1 and class 1 bi-maxillary protrusive subjects.
Specific aim Part II:
- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved incisors
- To compare length of treatment of both approaches.
- To evaluate the quality of treatment outcome of both treatment approaches according to American Board of Orthodontics (ABO) standards.
- Being tested
- Peizocorticision, Conventional Orthodontic Mechanics
- Keywords
- Accelerated orthodontic tooth movement (AOTM), Peizo-corticission
- Medical subject headings
- Malocclusion, Angle Class I, Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeizocorticisionProcedure or surgery
Also called AOTM Accelerated Orthodontic Tooth Movement
Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement
Conventional Orthodontic MechanicsProcedure or surgery
Also called Conv Orth Mech
Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics
| Study group | Role | What they receive |
|---|---|---|
| Conventional OrthodonticTreatment | Active comparator | Conventional orthodontic mechanics: canine and incisor retraction Receives: Procedure: Conventional Orthodontic Mechanics |
| Accelerated Tooth Movement | Experimental | Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction Receives: Procedure: Peizocorticision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of orthodontic canine movement
Measured: 4-6 months
Secondary outcomes (1)
Rate of orthodontic Incisor Retraction
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AL Yousef
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdullah International Medical Research Center
- Responsible party
- Sponsor-investigator, AL Yousef, King Abdullah International Medical Research Center
- Investigators
- Sally K Al-Yousef, MSc-Ortho, Principal investigator, KAIMRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549950
- Sponsor's protocol ID
- RC13/261/R
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.
PubMed 23810039
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Efficacy of Peizo-Coticision in Reducing Orthodontic Treatment Time: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02549950
- Acronym / sponsor ID
- RC13/261/R
- Keywords
- Accelerated orthodontic tooth movement (AOTM), Peizo-corticission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AL YousefUniversity, hospital or other
- Collaborators
- King Abdullah International Medical Research Center
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- 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 purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time.
Detailed description
1 Aim of the study- Part I:
This prospective controlled clinical trial (CCT), Split Mouth Design is conducted to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of canine teeth in class II div 1 subjects.
Specific aim- Part I:
A- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved canines
B- To compare length of treatment of both approaches.
2- Objectives of the Study Part II:
This prospective randomized controlled clinical trial (RCT) is designed to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of anterior teeth in class II div 1 and class 1 bi-maxillary protrusive subjects.
Specific aim Part II:
- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved incisors
- To compare length of treatment of both approaches.
- To evaluate the quality of treatment outcome of both treatment approaches according to American Board of Orthodontics (ABO) standards.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional OrthodonticTreatment | Active comparator | Procedure: Conventional Orthodontic MechanicsConventional orthodontic mechanics: canine and incisor retraction |
| Accelerated Tooth Movement | Experimental | Procedure: PeizocorticisionAccelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Voluntary participation of patients only
- Able to follow instruction, able to understand the consent form and sign it.
- Adult Female and Male Saudi patients 15-35 y.o
- Subjects who are none smokers
- Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.
Key exclusion criteria (17 listed)
- Subjects younger than 15 y.o
- Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves
- Subjects who are medically classified as ASA-II, III
- Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids
- Subjects who are pregnant
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 |
|---|---|---|
| PeizocorticisionAlso: AOTM Accelerated Orthodontic Tooth MovementPeizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement | Procedure or surgery | Accelerated Tooth Movement |
| Conventional Orthodontic MechanicsAlso: Conv Orth MechFull Fixed Orthodontic Appliance with conventional orthodontic Mechanics | Procedure or surgery | Conventional OrthodonticTreatment |
Primary outcome
Rate of orthodontic canine movement
Time frame: 4-6 months
1 secondary outcome
Rate of orthodontic Incisor Retraction
Time frame: 4-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Background: PubMed 23810039Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.
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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.
Sally K Al-Yousef, MSc-Ortho principal investigator
KAIMRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peizocorticision and Conventional Orthodontic Mechanics in people with Malocclusion, Angle Class I and Malocclusion; Angle Class II Division 1, run by AL Yousef at 1 site in Saudi Arabia.
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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Sep 2015. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally K Al-Yousef, Msc-Ortho (00966-11-8011111 ext. 14036, alyousefsa@ngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of orthodontic canine movement (time frame: 4-6 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 NCT02549950, which also lists 1 linked publication.
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 15 Sep 2015.