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The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and pain's interference, the level of satisfaction and comfort using this protocol. Finally root resorption associate with this technique will be evaluated.
This study will be randomized, split mouth design controlled trial with a 1:1 allocation ratio. One resident (A.A), calibrated by the main supervisor (S.M), will be reliable for recruiting the subjects, undertaking the orthodontic treatment under the supervision. The eligibility of the cases will be reevaluated by main supervisor (E.M) before the start of treatment.
Split mouth design will be utilized with MOPs that will be randomly assigned to the patients' left or right sides to eliminate the possibility of uneven occlusal forces because of habitual occlusion predominantly on 1 side and also the eliminate the biological variability between subjects. The allocation sequence will be concealed from the researcher (A.A) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes with the participant's the name and date of birth are written before the intervention. Allocation concealment seeks to prevent selection bias, protects the assignment sequence until allocation.
A Ethical approval will be granted by Jordan University of science and technology research center, and permission will be given at postgraduate dental clinics at Jordan University of science and technology, Irbid, Jordan.
We hypothesized that 50% increased in rate of tooth movement in MOP group would produce a clinically significant difference. The sample size was calculated depend on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups with 50% of acceleration rate of tooth movement, the power analysis yields a total sample size estimate of 44 samples at a conventional alpha-level (p = 0.05) and desired power (1 - β err prob) of 0.90, yielding 22 samples per group (means 22 patients that represent 22 MOP group and 22 Control group). Assuming an overall attrition rate of 15%, initial recruitment should target a total of 55 samples with 18 patients per group. All calculations were performed with the computer application G-Power (Erdfelder et al., 1996)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOP side | Experimental | Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine. |
|
| control side | No Intervention | No intervention in the other side of maxilla (control side) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro-osteoperforation | Device | Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute. |
| Measure | Description | Time Frame |
|---|---|---|
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines. | Baseline to 1st month |
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines. | Baseline to 2nd month |
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines. | Baseline to 3rd month |
| Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | Baseline to 1st month |
| Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | Baseline to 2nd month |
| Intra Oral Measurements of Canine Rate of Tooth Movement |
| Measure | Description | Time Frame |
|---|---|---|
| Root Resorption | It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period | Baseline to 3rd month |
| Pain Intensity | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. |
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Inclusion Criteria:
Exclusion Criteria:
Cephalometric analysis of the included subjects was performed at baseline including
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| Name | Affiliation | Role |
|---|---|---|
| Amal A Alkebsi, MClinDent | Jordan University of Science and Technology | Principal Investigator |
| Emad Al Maaitah, Ph.D. | Jordan University of Science and Technology | Principal Investigator |
| Hisham Alshorman, Ph.D. | Jordan University of Science and Technology | Principal Investigator |
| Elham S. Abu Alhaija, Ph.D | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | 22110 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29853235 | Derived | 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. |
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Upon request.
As soon as it published and it to be available anytime.
Official departments of recognized universities
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Participants recruited from a postgraduate clinic at Jordanian University of Science and Technology, in Irbid city, Jordan between Aug 2015 and Jan 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Split-mouth design study in which the intervention (MOP Side) was randomly assigned to either right or the left side in the maxillary arch where other side serves as a control. Randomization was accomplished with block randomization with a permuted block size of 2 with 1:1 allocation ratio to either right or left with allocations concealed in opaque, sealed envelopes. Blinding was applicable at data collection and analysis stage. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes groups randomized to receive MOP intervention on one side while the other side serve as control side. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines. | Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion. | Posted | Mean | Standard Deviation | mm | Baseline to 1st month |
|
3 months after intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOP Side | Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine. Micro-osteoperforation: Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Amal Alkebsi | Jordanian University of science and Technology | 00966552358684 | amalkibsi@gmail.com,aalkebsi13@den.just.edu.jo |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2017 | Nov 10, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. |
| Baseline to 3 month |
| within 7 days after the intervention |
| Pain Interference /Pain During Eating? | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | within 7 days after the intervention |
| Pain Interference /Pain Interrupted Sleep | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | within 7 days after the intervention |
| Pain Interference /Swelling of the Surgical Side | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling. | within 7 days after the intervention |
| Pain Interference /Discomfort | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort. | within 7 days after the intervention |
| Patient Satisfaction | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction. | After 7 days of MOP application |
| Menstrual Cycle | the relationship between the rate of tooth movement and Menstrual cycle | within 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sella-Nasion to A Point Angle (SNA) | Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base. | Mean | Standard Deviation | Degree |
|
| Sella-Nasion to B Point Angle (SNB) | Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base. | Mean | Standard Deviation | Degree |
|
| A point to B Point Angle (ANB) | A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible. | Mean | Standard Deviation | Degree |
|
| Maxillary mandibular plane angle | The angle formed between the Maxillary Plane and Mandibular Plane. | Mean | Standard Deviation | Degree |
|
| Lower anterior facial height(LAFH) | Mean | Standard Deviation | mm |
|
| Upper incisor inclination | The angle between the maxillary plane and the axis of the maxillary incisors. | Mean | Standard Deviation | Degree |
|
|
|
|
| Primary | 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines. | Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. only one impression was lost to be taken by a clinician at two months period. | Posted | Mean | Standard Deviation | mm | Baseline to 2nd month |
|
|
|
|
| Primary | 3D Digital Model Measurements of Canine Rate of Tooth Movement | The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines. | Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion, and only one impression was lost to be taken by a clinician at two months. | Posted | Mean | Standard Deviation | mm | Baseline to 3rd month |
|
|
|
|
| Primary | Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | 32 subjects were analyzed to receive MOP to either right or left sides. Only one patient was lost to follow up at the first month time point. | Posted | Mean | Standard Deviation | mm | Baseline to 1st month |
|
|
|
|
| Primary | Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | 32 subjects were analyzed to receive MOP to either right or left sides. | Posted | Mean | Standard Deviation | mm | Baseline to 2nd month |
|
|
|
|
| Primary | Intra Oral Measurements of Canine Rate of Tooth Movement | Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months. | 32 subjects were analyzed who received MOP to either right or left sides. | Posted | Mean | Standard Deviation | mm | Baseline to 3 month |
|
|
|
|
| Secondary | Root Resorption | It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period | Posted | Mean | Standard Deviation | mm | Baseline to 3rd month |
|
|
|
|
| Secondary | Pain Intensity | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | Posted | Mean | Standard Deviation | units on a scale | within 7 days after the intervention |
|
|
|
|
| Secondary | Pain Interference /Pain During Eating? | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | Posted | Mean | Standard Deviation | units on a scale | within 7 days after the intervention |
|
|
|
|
| Secondary | Pain Interference /Pain Interrupted Sleep | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain. | Posted | Mean | Standard Deviation | units on a scale | within 7 days after the intervention |
|
|
|
|
| Secondary | Pain Interference /Swelling of the Surgical Side | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling. | Posted | Mean | Standard Deviation | units on a scale | within 7 days after the intervention |
|
|
|
|
| Secondary | Pain Interference /Discomfort | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort. | Posted | Mean | Standard Deviation | units on a scale | within 7 days after the intervention |
|
|
|
|
| Secondary | Patient Satisfaction | It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction. | Posted | Mean | Standard Deviation | units on a scale | After 7 days of MOP application |
|
|
|
|
| Secondary | Menstrual Cycle | the relationship between the rate of tooth movement and Menstrual cycle | Sufficient data were not collected from any participant | Posted | within 3 months |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control Side | No intervention in the other side of maxilla (control side) | 0 | 32 | 0 | 32 | 0 | 32 |
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| 0.48 |
| Other |
| 12 hour |
|
| Day 1 |
|
| Day 3 |
|
| Day 5 |
|
| Day 7 |
|
| 0.092 |
| Other |
| 12 hour after intervention | t-test, 2 sided | 0.100 | Other |
| Day 1 after intervention | t-test, 2 sided | 0.302 | Other |
| Day 3 after intervention | t-test, 2 sided | 0.582 | Other |
| Day 5 after intervention | t-test, 2 sided | 0.743 | Other |
| Day 7 after intervention | t-test, 2 sided | 0.809 | Other |
| Day 5 |
|
| Day 7 |
|
| Other |
| Day 5 | t-test, 2 sided | 0.57 | Other |
| Day 7 | t-test, 2 sided | 0.82 | Other |
| Day 5 |
|
| Day 7 |
|
| Other |
| Day 5 | t-test, 2 sided | 0.33 | Other |
| Day 7 | t-test, 2 sided | > 0.05 | Other |
| Day 5 |
|
| Day 7 |
|
| Other |
| Day 5 | t-test, 2 sided | 0.09 | Other |
| t-test, 2 sided | 0.16 | Other |
| Day 5 |
|
| Day 7 |
|
| Other |
| Day 5 | t-test, 2 sided | 0.30 | Other |
| Day 7 | t-test, 2 sided | 0.56 | Other |