MalocclusionNCT02975765
Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth
A study testing Piezosurgery in people with Malocclusion and Crowded Teeth, 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 16 to 26 years
- Conditions the study is for
- Malocclusion, Crowded Teeth, Surgical Incision
- 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 23 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 16 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult healthy patients , Male and female, Age range: 16-26 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 Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: 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 levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.
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 on their acceptance and compatibility is little in the literature.
- Conditions
- Malocclusion, Crowded Teeth, Surgical Incision
- Being tested
- Piezosurgery
- Keywords
- corticotomy, minimally invasive, piezosurgery, piezocision, pain, discomfort
- Medical subject headings
- Malocclusion, Crowding, Surgical Wound, Pain
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 surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.
| Study group | Role | What they receive |
|---|---|---|
| Piezosurgery | Experimental | Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment Receives: Procedure: Piezosurgery |
| Traditional method | No intervention | No intervention is going to be applied to the patients in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Pain and Discomfort at one day
Pain and discomfort will be measured on visual analog scale
Measured: at 24 hours following the engagement of first initial arch wire in the brackets
Levels of Pain and Discomfort at seven days
Pain and discomfort will be measured on visual analog scale
Measured: at seven days following the onset of orthodontic treatment
Levels of Pain and Discomfort at 14 days
Pain and discomfort will be measured on visual analog scale
Measured: at 14 days following the onset of orthodontic treatment
Levels of Pain and Discomfort at 28 days
Pain and discomfort will be measured on visual analog scale
Measured: at 28 days following the onset of orthodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMar 2016
- Primary completion12 Dec 2016
- Study completion23 Apr 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 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
- 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
- NCT02975765
- Sponsor's protocol ID
- UDDS-OMFS-02-2016
- Status last verified
- Jul 2017
- First submitted
- 24 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. 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
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 Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower Anterior Teeth: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02975765
- Acronym / sponsor ID
- UDDS-OMFS-02-2016
- Conditions
- Malocclusion, Crowded Teeth, Surgical Incision
- Keywords
- corticotomy, minimally invasive, piezosurgery, piezocision, pain, discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 23 Apr 2017 (actual)
- First posted
- 29 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 levels of pain and discomfort of this procedure on 18 patients (experimental group) will be evaluated,whereas the second group (control group) will receive a traditional orthodontic therapy.
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 on their acceptance and compatibility is little in the literature.
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-assisted corticotomy will be performed to enhance teeth alignment |
| Traditional method | No intervention | –No intervention is going to be applied to the patients in this group. |
Who may qualify
- Ages
- 16 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Adult healthy patients , Male and female, Age range: 16-26 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 surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth. | Procedure or surgery | Piezosurgery |
Primary outcome
Levels of Pain and Discomfort at one day
Time frame: at 24 hours following the engagement of first initial arch wire in the brackets
Pain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at seven days
Time frame: at seven days following the onset of orthodontic treatment
Pain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at 14 days
Time frame: at 14 days following the onset of orthodontic treatment
Pain and discomfort will be measured on visual analog scale
Levels of Pain and Discomfort at 28 days
Time frame: at 28 days following the onset of orthodontic treatment
Pain and discomfort will be measured on visual analog scale
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 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.
- Individual participant dataSharing planned: No
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
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 Malocclusion and Crowded Teeth, 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?
Levels of Pain and Discomfort at one day (time frame: at 24 hours following the engagement of first initial arch wire in the brackets). 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 NCT02975765, 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.