Surgical IncisionNCT02977221
Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment
A study testing Piezosurgery in people with Surgical Incision and Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. Read more about this study
- Who is it for?
- Ages 15 to 27 years
- Conditions the study is for
- Surgical Incision, Malocclusion
- What is being tested?
- Piezosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSyria
- Study dates
- Mar 2016to Apr 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 27 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.
- Severe crowding ≤ 7 (Little's irregularity index)
- Permanent occlusion.
- Exist all the Mandibular teeth (except third molars).
- Good oral and periodontal health:
- Probing depth<4 mm
Show all 9Show fewer
- No radiographic evidence of bone loss .
- Gingival index≤ 1
- Plaque index ≤ 1
Who cannot join
- Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
- Patients have anti indication for oral surgery ( medical - social - psycho)
- Presence of primary teeth in the mandibular arch
- Missing permanent mandibular teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm
Show all 10Show fewer
- radiographic evidence of bone loss
- Gingival index > 1
- Plaque index > 1
- Patient had previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Syria1 site
Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial
Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The efficacy of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy. The time required to achieve complete alignment of crowded mandibular anterior teeth (from canine to canine) will be compared between the two groups.
Read the detailed description
According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.
Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence for their effectiveness so far has been limited to case series and a few clinical trials, generally with small groups. This study aims to provide some evidence about the efficacy of piezosurgery in a flapless technique to align crowded lower anterior teeth using a parallel-group randomized controlled trial study design.
- Conditions
- Surgical Incision, Malocclusion
- Being tested
- Piezosurgery
- Keywords
- corticotomy, piezocision, piezosurgery, acceleration of tooth movement, crowded anterior teeth
- Medical subject headings
- Surgical Wound, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezosurgeryProcedure or surgery
Also called Piezocision
The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth.
| Study group | Role | What they receive |
|---|---|---|
| Piezosurgery | Experimental | Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding. Receives: Procedure: Piezosurgery |
| Ordinary Alignment | No intervention | Treatment will be provided to the patients without any surgical interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of tooth alignment
This outcome will be measured in 'days'.
Measured: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
Change in Tooth Alignment at one month
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Measured: Little Index of Irregularity will be measured at 30 days after the onset of treatment.
Change in Tooth Alignment at two months
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Measured: Little Index of Irregularity will be measured at 60 days after the onset of treatment.
Change in Tooth Alignment at last assessment time
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Measured: Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical IncisionStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Gibreal, DDS, Principal investigator, MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental SchoolBassel Brad, DDS MSc PhD, Study director, Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental SchoolMohammad Y Hajeer, DDS MSc PhD, Study director, Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977221
- Sponsor's protocol ID
- UDDS-OMFS-01-2016
- Status last verified
- Jul 2017
- First submitted
- 23 Nov 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
PubMed 22105680Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
PubMed 17726988Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
PubMed 24286911Gibreal O, Hajeer MY, Brad B. Efficacy of piezocision-based flapless corticotomy in the orthodontic correction of severely crowded lower anterior teeth: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):188-195. doi: 10.1093/ejo/cjy042.
PubMed 29931294
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02977221
- Acronym / sponsor ID
- UDDS-OMFS-01-2016
- Conditions
- Surgical Incision, Malocclusion
- Keywords
- corticotomy, piezocision, piezosurgery, acceleration of tooth movement, crowded anterior teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Nov 2016 (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.
Applying flapless piezocision corticotomies on the alveolar bone and separating anterior mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very accurate incisions without any sutures following this procedure) may improve the speed of tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups. The efficacy of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy. The time required to achieve complete alignment of crowded mandibular anterior teeth (from canine to canine) will be compared between the two groups.
Detailed description
According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.
Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence for their effectiveness so far has been limited to case series and a few clinical trials, generally with small groups. This study aims to provide some evidence about the efficacy of piezosurgery in a flapless technique to align crowded lower anterior teeth using a parallel-group randomized controlled trial study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezosurgery | Experimental | Procedure: PiezosurgeryPiezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding. |
| Ordinary Alignment | No intervention | –Treatment will be provided to the patients without any surgical interventions. |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Adult healthy patients , Male and female, Age range: 15-27 years.
- Severe crowding ≤ 7 (Little's irregularity index)
- Permanent occlusion.
- Exist all the Mandibular teeth (except third molars).
- Good oral and periodontal health:
Key exclusion criteria (10 listed)
- Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
- Patients have anti indication for oral surgery ( medical - social - psycho)
- Presence of primary teeth in the mandibular arch
- Missing permanent mandibular teeth (except third molars).
- Poor oral hygiene or Current 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 |
|---|---|---|
| PiezosurgeryAlso: PiezocisionThe device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth. | Procedure or surgery | Piezosurgery |
Primary outcome
Duration of tooth alignment
Time frame: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
This outcome will be measured in 'days'.
Change in Tooth Alignment at one month
Time frame: Little Index of Irregularity will be measured at 30 days after the onset of treatment.
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Change in Tooth Alignment at two months
Time frame: Little Index of Irregularity will be measured at 60 days after the onset of treatment.
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
Change in Tooth Alignment at last assessment time
Time frame: Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
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 27 Jul 2017.
- Background: PubMed 22105680Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
- Background: PubMed 17726988Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
- Background: PubMed 24286911Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
- Derived from this study: PubMed 29931294Gibreal O, Hajeer MY, Brad B. Efficacy of piezocision-based flapless corticotomy in the orthodontic correction of severely crowded lower anterior teeth: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):188-195. doi: 10.1093/ejo/cjy042.
- 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.
Omar Gibreal, DDS principal investigator
MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
Bassel Brad, DDS MSc PhD study director
Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
Mohammad Y Hajeer, DDS MSc PhD study director
Associate 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 Piezosurgery in people with Surgical Incision and 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 9 inclusion and 10 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 27 Jul 2017. 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 tooth alignment (time frame: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation). 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 NCT02977221, which also lists 4 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 27 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.