OrthodonticsNCT03450278
Effect of Micro-osteoperforation on the Rate of Canine Retraction
A study testing micro-osteoperforation in people with Orthodontics, run by Cairo University.
Trial summary
The current study Is a split-mouth Randomized Controlled Trial that was performed to investigate three dimensionally, using digital models and Cone Beam Computed Tomography imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a canine retraction model. Read more about this study
- Who is it for?
- Ages 16 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 10 Jan 2018
- 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 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Malocclusion that requires bilateral extraction of the maxillary first premolars and canine retraction with maximum anchorage; Class II division 1 and bimaxillary dentoalveolar protrusion cases.
- Full permanent dentition with exception of the third molars.
- Good oral hygiene and periodontal condition.
Who cannot join
- Medically compromised patients.
- Patients suffering from any congenital, hereditary or systemic diseases.
- Chronic use of any medications affecting orthodontic tooth movement (e.g. corticosteroids, hormonal therapy, NSAIDs)
- Patients with dental anomalies (e.g. enamel hypoplasia, root dilacerations in maxillary canines).
- Patients with medical conditions that contraindicate surgeries (e.g. bleeding tendency and immunocompromised patients).
- Radiographic evidence of bone loss.
About this study
Official title: Effect of Micro-osteoperforation on the Rate of Canine Retraction: A Split Mouth Randomized Controlled Trial
The current study Is a split-mouth Randomized Controlled Trial that was performed to investigate three dimensionally, using digital models and Cone Beam Computed Tomography imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a canine retraction model.
Read the detailed description
Sample size calculation was carried out and resulted in enrolment of 18 female patients requiring bilateral upper first premolars extraction and canine retraction with maximum anchorage. The sample was recruited from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.
After placement of the fixed orthodontic appliance, leveling and alignment proceeded till 0.016" × 0.022" NiTi upper archwire. Indirect skeletal anchorage was then prepared using TADs inserted bilaterally between the upper 1st molar and 2nd premolar, and the patient was referred for upper 1st premolars extraction.
Three months after extraction, 0.017" × 0.025" stainless-steel upper archwire was inserted and three vertically aligned MOPs were randomly allocated and performed in one side using a single TAD, while the other side served as control. The three MOPs were performed distal to the canine, equidistant in the extraction space. Bilateral canine retraction was then commenced using NiTi closing coil springs delivering 150 gms of force. Before leaving the clinic, a pain questionnaire was given to each patient.
Data were collected from monthly upper impressions, which were poured into stone models and scanned to obtain sequential digital models (T0, T1, T2, T3 \& T4), in addition to pre- and post-retraction maxillary CBCT images.
The assessed outcomes were the rate of canine retraction per month, the total distance travelled by the upper canines, first molars anchorage loss, tipping, torque and rotation of upper canines and first molars, canine root resorption and finally the pain related to MOP procedure. Statistical analysis was performed on the gathered data and results were withdrawn.
- Conditions
- Orthodontics
- Being tested
- micro-osteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforationProcedure or surgery
Also called alveolocentesis, bone puncturing, flapless corticotomy
Minor surgical procedure including performance of limited and shallow perforations of the cortical plate of bone to increase the expression of inflammatory cytokines, hence accelerating orthodontic tooth movement.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | canine retraction without any means of acceleration. |
| micro-osteoperforation | Experimental | canine retraction accelerated with micro-osteoperforation Receives: Procedure: micro-osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of maxillary canine retraction
distance (mm) moved by the canine distally per month
Measured: 4 months of canine retraction
Secondary outcomes (5)
Maxillary first molar anchorage loss
anchorage loss (mesial movement) of the maxillary first molar occuring after 4 months of canine retraction.
Measured: 4 months of canine retraction
Maxillary canine tipping, torque and rotation
change in the three dimensional axial inclination (tipping, torque and rotation) of the maxillary canine after 4 months of retraction
Measured: 4 months of canine retraction
Maxillary first molar tipping, torque and rotation
change in the three-dimensional axial inclination (tipping, torque and rotation) of the maxillary first molar after 4 months of canine retraction.
Measured: 4 months of canine retraction
Maxillary canine root resorption
amount of canine root resorption occurred after 4 moths of retraction
Measured: 4 months of canine retraction
Pain caused by the micro-osteoperforation procedure
Pain assessed using the Numeric Pain Rating Scale (0-10) assessed immediately after the micro-osteoperforation (MOP) procedure, 1 day, 3 days and 1 week after the MOP procedure. 0 pain score: no pain, (1-3) pain score: mild pain, (3-6) pain scores: moderate pain, (7-10) pain score: severe pain.
Measured: 1 week after the micro-osteoperforation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study startDec 2015
- Primary completion3 Jan 2018
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Aboalnaga, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450278
- Sponsor's protocol ID
- CEBD-CU-2015-07-10
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Micro-osteoperforation on the Rate of Canine Retraction: A Split Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03450278
- Acronym / sponsor ID
- CEBD-CU-2015-07-10
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 1 Mar 2018 (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.
The current study Is a split-mouth Randomized Controlled Trial that was performed to investigate three dimensionally, using digital models and Cone Beam Computed Tomography imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a canine retraction model.
Detailed description
Sample size calculation was carried out and resulted in enrolment of 18 female patients requiring bilateral upper first premolars extraction and canine retraction with maximum anchorage. The sample was recruited from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.
After placement of the fixed orthodontic appliance, leveling and alignment proceeded till 0.016" × 0.022" NiTi upper archwire. Indirect skeletal anchorage was then prepared using TADs inserted bilaterally between the upper 1st molar and 2nd premolar, and the patient was referred for upper 1st premolars extraction.
Three months after extraction, 0.017" × 0.025" stainless-steel upper archwire was inserted and three vertically aligned MOPs were randomly allocated and performed in one side using a single TAD, while the other side served as control. The three MOPs were performed distal to the canine, equidistant in the extraction space. Bilateral canine retraction was then commenced using NiTi closing coil springs delivering 150 gms of force. Before leaving the clinic, a pain questionnaire was given to each patient.
Data were collected from monthly upper impressions, which were poured into stone models and scanned to obtain sequential digital models (T0, T1, T2, T3 \& T4), in addition to pre- and post-retraction maxillary CBCT images.
The assessed outcomes were the rate of canine retraction per month, the total distance travelled by the upper canines, first molars anchorage loss, tipping, torque and rotation of upper canines and first molars, canine root resorption and finally the pain related to MOP procedure. Statistical analysis was performed on the gathered data and results were withdrawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –canine retraction without any means of acceleration. |
| micro-osteoperforation | Experimental | Procedure: micro-osteoperforationcanine retraction accelerated with micro-osteoperforation |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Malocclusion that requires bilateral extraction of the maxillary first premolars and canine retraction with maximum anchorage; Class II division 1 and bimaxillary dentoalveolar protrusion cases.
- Full permanent dentition with exception of the third molars.
- Good oral hygiene and periodontal condition.
Key exclusion criteria (6 listed)
- Medically compromised patients.
- Patients suffering from any congenital, hereditary or systemic diseases.
- Chronic use of any medications affecting orthodontic tooth movement (e.g. corticosteroids, hormonal therapy, NSAIDs)
- Patients with dental anomalies (e.g. enamel hypoplasia, root dilacerations in maxillary canines).
- Patients with medical conditions that contraindicate surgeries (e.g. bleeding tendency and immunocompromised patients).
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 |
|---|---|---|
| micro-osteoperforationAlso: alveolocentesis, bone puncturing, flapless corticotomyMinor surgical procedure including performance of limited and shallow perforations of the cortical plate of bone to increase the expression of inflammatory cytokines, hence accelerating orthodontic tooth movement. | Procedure or surgery | micro-osteoperforation |
Primary outcome
Rate of maxillary canine retraction
Time frame: 4 months of canine retraction
distance (mm) moved by the canine distally per month
5 secondary outcomes
Maxillary first molar anchorage loss
Time frame: 4 months of canine retraction
Maxillary canine tipping, torque and rotation
Time frame: 4 months of canine retraction
Maxillary first molar tipping, torque and rotation
Time frame: 4 months of canine retraction
Maxillary canine root resorption
Time frame: 4 months of canine retraction
Pain caused by the micro-osteoperforation procedure
Time frame: 1 week after the micro-osteoperforation procedure
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 1 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing micro-osteoperforation in people with Orthodontics, run by Cairo University.
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 3 inclusion and 6 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of maxillary canine retraction (time frame: 4 months of canine retraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2018.