Malocclusion
Conditions
Keywords
Micro-Osteoperforation (MOPs), regional acceleratory phenomenon (RAP), Malocculsion
Brief summary
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.
Detailed description
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)
Interventions
DEVICEMicro-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.
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female * between 16 to 26 years old * Class II Division 1 malocclusion or bimaxillary protrusion * Average Lower facial height and Mandibular plane angle * No systemic disease * Healthy periodontal condition * Non smoker * Probing depth less than 4 mm in all teeth
Exclusion criteria
* Long-term use of any Medication * Poor oral hygiene * Low and high angle cases * Systemic disease * Evidence of bone loss * Active periodontal disease * Smoker * Probing depth more than 4 mm in all teeth Cephalometric analysis of the included subjects was performed at baseline including 1. Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base. 2. Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base. 3. A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible. 4. Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a line through the gonion and menton. 5. Lower anterior facial height(LAFH) 6. Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D Digital Model Measurements of Canine Rate of Tooth Movement | Baseline to 1st month | The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines. |
| Intra Oral Measurements of Canine Rate of Tooth Movement | Baseline to 1st month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference /Pain During Eating? | within 7 days after the intervention | 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. |
| Pain Interference /Pain Interrupted Sleep | within 7 days after the intervention | 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. |
| Pain Interference /Swelling of the Surgical Side | within 7 days after the intervention | 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. |
| Root Resorption | Baseline to 3rd month | It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period |
| Patient Satisfaction | After 7 days of MOP application | 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. |
| Menstrual Cycle | within 3 months | the relationship between the rate of tooth movement and Menstrual cycle |
| Pain Interference /Discomfort | within 7 days after the intervention | 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. |
| Pain Intensity | within 7 days after the intervention | 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. |
Countries
Jordan
Participant flow
Recruitment details
Participants recruited from a postgraduate clinic at Jordanian University of Science and Technology, in Irbid city, Jordan between Aug 2015 and Jan 2016.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes groups randomized to receive MOP intervention on one side while the other side serve as control side. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | poor oral hygiene | 2 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 19.26 years STANDARD_DEVIATION 2.48 |
| A point to B Point Angle (ANB) | 5.5 Degree STANDARD_DEVIATION 2.69 |
| Lower anterior facial height(LAFH) | 55.67 mm STANDARD_DEVIATION 1.81 |
| Maxillary mandibular plane angle | 28.9 Degree STANDARD_DEVIATION 4.27 |
| Region of Enrollment Jordan | 35 participants |
| Sella-Nasion to A Point Angle (SNA) | 81.9 Degree STANDARD_DEVIATION 4.07 |
| Sella-Nasion to B Point Angle (SNB) | 76.5 Degree STANDARD_DEVIATION 3.85 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 10 Participants |
| Upper incisor inclination | 119.94 Degree STANDARD_DEVIATION 7.53 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
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.
Time frame: Baseline to 1st month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | 3D Digital Model Measurements of Canine Rate of Tooth Movement | 0.65 mm | Standard Deviation 0.26 |
| Control Side | 3D Digital Model Measurements of Canine Rate of Tooth Movement | 0.67 mm | Standard Deviation 0.34 |
p-value: 0.77t-test, 2 sided
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.
Time frame: Baseline to 3rd month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | 3D Digital Model Measurements of Canine Rate of Tooth Movement | 1.93 mm | Standard Deviation 0.74 |
| Control Side | 3D Digital Model Measurements of Canine Rate of Tooth Movement | 1.88 mm | Standard Deviation 0.67 |
p-value: 0.76t-test, 2 sided
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.
Time frame: Baseline to 2nd month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | 3D Digital Model Measurements of Canine Rate of Tooth Movement | 1.36 mm | Standard Deviation 0.49 |
| Control Side | 3D Digital Model Measurements of Canine Rate of Tooth Movement | 1.28 mm | Standard Deviation 0.5 |
p-value: 0.5t-test, 2 sided
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.
Time frame: Baseline to 3 month
Population: 32 subjects were analyzed who received MOP to either right or left sides.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | Intra Oral Measurements of Canine Rate of Tooth Movement | 3.18 mm | Standard Deviation 1.03 |
| Control Side | Intra Oral Measurements of Canine Rate of Tooth Movement | 3.26 mm | Standard Deviation 0.81 |
p-value: 0.74t-test, 2 sided
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.
Time frame: Baseline to 1st month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | Intra Oral Measurements of Canine Rate of Tooth Movement | 1.23 mm | Standard Deviation 0.45 |
| Control Side | Intra Oral Measurements of Canine Rate of Tooth Movement | 1.17 mm | Standard Deviation 0.42 |
p-value: 0.56t-test, 2 sided
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.
Time frame: Baseline to 2nd month
Population: 32 subjects were analyzed to receive MOP to either right or left sides.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | Intra Oral Measurements of Canine Rate of Tooth Movement | 2.27 mm | Standard Deviation 0.72 |
| Control Side | Intra Oral Measurements of Canine Rate of Tooth Movement | 2.24 mm | Standard Deviation 0.63 |
p-value: 0.88t-test, 2 sided
Secondary
Menstrual Cycle
the relationship between the rate of tooth movement and Menstrual cycle
Time frame: within 3 months
Population: Sufficient data were not collected from any participant
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.
Time frame: within 7 days after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOP Side | Pain Intensity | 12 hour | 2.6 units on a scale | Standard Deviation 2.79 |
| MOP Side | Pain Intensity | Day 3 | 0.8 units on a scale | Standard Deviation 1.41 |
| MOP Side | Pain Intensity | 1 hour | 2.4 units on a scale | Standard Deviation 2.15 |
| MOP Side | Pain Intensity | Day 5 | 0.4 units on a scale | Standard Deviation 1.1 |
| MOP Side | Pain Intensity | Day 1 | 1.2 units on a scale | Standard Deviation 1.95 |
| MOP Side | Pain Intensity | Day 7 | 0.2 units on a scale | Standard Deviation 0.71 |
| MOP Side | Pain Intensity | Immediate | 1.4 units on a scale | Standard Deviation 1.74 |
| Control Side | Pain Intensity | Day 7 | 0.3 units on a scale | Standard Deviation 1.28 |
| Control Side | Pain Intensity | Immediate | 1.0 units on a scale | Standard Deviation 1.99 |
| Control Side | Pain Intensity | 1 hour | 1.5 units on a scale | Standard Deviation 2.23 |
| Control Side | Pain Intensity | 12 hour | 1.6 units on a scale | Standard Deviation 2.35 |
| Control Side | Pain Intensity | Day 1 | 0.8 units on a scale | Standard Deviation 1.36 |
| Control Side | Pain Intensity | Day 3 | 0.6 units on a scale | Standard Deviation 1.29 |
| Control Side | Pain Intensity | Day 5 | 0.3 units on a scale | Standard Deviation 1.18 |
Comparison: Immediate after interventionp-value: 0.388t-test, 2 sided
Comparison: 1 hour after interventionp-value: 0.092t-test, 2 sided
Comparison: 12 hour after interventionp-value: 0.1t-test, 2 sided
Comparison: Day 1 after interventionp-value: 0.302t-test, 2 sided
Comparison: Day 3 after interventionp-value: 0.582t-test, 2 sided
Comparison: Day 5 after interventionp-value: 0.743t-test, 2 sided
Comparison: Day 7 after interventionp-value: 0.809t-test, 2 sided
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.
Time frame: within 7 days after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOP Side | Pain Interference /Discomfort | Day 1 | 2.10 units on a scale | Standard Deviation 2.52 |
| MOP Side | Pain Interference /Discomfort | Day 3 | 0.77 units on a scale | Standard Deviation 1.36 |
| MOP Side | Pain Interference /Discomfort | Day 5 | 0.23 units on a scale | Standard Deviation 0.56 |
| MOP Side | Pain Interference /Discomfort | Day 7 | 0.06 units on a scale | Standard Deviation 0.25 |
| Control Side | Pain Interference /Discomfort | Day 7 | 0.03 units on a scale | Standard Deviation 0.18 |
| Control Side | Pain Interference /Discomfort | Day 1 | 1.29 units on a scale | Standard Deviation 2.19 |
| Control Side | Pain Interference /Discomfort | Day 5 | 0.10 units on a scale | Standard Deviation 0.4 |
| Control Side | Pain Interference /Discomfort | Day 3 | 0.58 units on a scale | Standard Deviation 1.29 |
Comparison: Day 1p-value: 0.18t-test, 2 sided
Comparison: Day 3p-value: 0.57t-test, 2 sided
Comparison: Day 5p-value: 0.3t-test, 2 sided
Comparison: Day 7p-value: 0.56t-test, 2 sided
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.
Time frame: within 7 days after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOP Side | Pain Interference /Pain During Eating? | Day 1 | 3.10 units on a scale | Standard Deviation 2.61 |
| MOP Side | Pain Interference /Pain During Eating? | Day 3 | 1.03 units on a scale | Standard Deviation 1.58 |
| MOP Side | Pain Interference /Pain During Eating? | Day 5 | 0.29 units on a scale | Standard Deviation 0.74 |
| MOP Side | Pain Interference /Pain During Eating? | Day 7 | 0.13 units on a scale | Standard Deviation 0.56 |
| Control Side | Pain Interference /Pain During Eating? | Day 7 | 0.10 units on a scale | Standard Deviation 0.54 |
| Control Side | Pain Interference /Pain During Eating? | Day 1 | 2.00 units on a scale | Standard Deviation 2.54 |
| Control Side | Pain Interference /Pain During Eating? | Day 5 | 0.19 units on a scale | Standard Deviation 0.6 |
| Control Side | Pain Interference /Pain During Eating? | Day 3 | 0.65 units on a scale | Standard Deviation 1.23 |
Comparison: Day 1p-value: 0.09t-test, 2 sided
Comparison: Day 3p-value: 0.29t-test, 2 sided
Comparison: Day 5p-value: 0.57t-test, 2 sided
Comparison: Day 7p-value: 0.82t-test, 2 sided
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.
Time frame: within 7 days after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOP Side | Pain Interference /Pain Interrupted Sleep | Day 1 | 0.58 units on a scale | Standard Deviation 1.69 |
| MOP Side | Pain Interference /Pain Interrupted Sleep | Day 3 | 0.13 units on a scale | Standard Deviation 0.56 |
| MOP Side | Pain Interference /Pain Interrupted Sleep | Day 5 | 0.06 units on a scale | Standard Deviation 0.36 |
| MOP Side | Pain Interference /Pain Interrupted Sleep | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Control Side | Pain Interference /Pain Interrupted Sleep | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Control Side | Pain Interference /Pain Interrupted Sleep | Day 1 | 0.19 units on a scale | Standard Deviation 0.91 |
| Control Side | Pain Interference /Pain Interrupted Sleep | Day 5 | 0.00 units on a scale | Standard Deviation 0 |
| Control Side | Pain Interference /Pain Interrupted Sleep | Day 3 | 0.03 units on a scale | Standard Deviation 0.18 |
Comparison: Day 1p-value: 0.27t-test, 2 sided
Comparison: Day 3p-value: 0.37t-test, 2 sided
Comparison: Day 5p-value: 0.33t-test, 2 sided
Comparison: Day 7p-value: >0.05t-test, 2 sided
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.
Time frame: within 7 days after the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOP Side | Pain Interference /Swelling of the Surgical Side | Day 1 | 1.23 units on a scale | Standard Deviation 1.68 |
| MOP Side | Pain Interference /Swelling of the Surgical Side | Day 3 | 0.48 units on a scale | Standard Deviation 1.18 |
| MOP Side | Pain Interference /Swelling of the Surgical Side | Day 5 | 0.26 units on a scale | Standard Deviation 0.82 |
| MOP Side | Pain Interference /Swelling of the Surgical Side | Day 7 | 0.06 units on a scale | Standard Deviation 0.25 |
| Control Side | Pain Interference /Swelling of the Surgical Side | Day 7 | 0.00 units on a scale | Standard Deviation 0 |
| Control Side | Pain Interference /Swelling of the Surgical Side | Day 1 | 0.41 units on a scale | Standard Deviation 1.38 |
| Control Side | Pain Interference /Swelling of the Surgical Side | Day 5 | 0.00 units on a scale | Standard Deviation 0 |
| Control Side | Pain Interference /Swelling of the Surgical Side | Day 3 | 0.26 units on a scale | Standard Deviation 1.26 |
Comparison: Day 1p-value: 0.05t-test, 2 sided
Comparison: Day 3p-value: 0.47t-test, 2 sided
Comparison: Day 5p-value: 0.09t-test, 2 sided
p-value: 0.16t-test, 2 sided
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.
Time frame: After 7 days of MOP application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MOP Side | Patient Satisfaction | 8.94 units on a scale | Standard Deviation 1.35 |
p-value: <0.05Descriptive statistics
Secondary
Root Resorption
It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period
Time frame: Baseline to 3rd month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MOP Side | Root Resorption | Root length at baseline | 19.96 mm | Standard Deviation 2.2 |
| MOP Side | Root Resorption | Root length at 3 months | 19.35 mm | Standard Deviation 2 |
| Control Side | Root Resorption | Root length at baseline | 19.66 mm | Standard Deviation 2.5 |
| Control Side | Root Resorption | Root length at 3 months | 18.93 mm | Standard Deviation 2.6 |
Comparison: Root length at baseline.p-value: 0.59t-test, 2 sided
Comparison: Root length at 3 monthsp-value: 0.48t-test, 2 sided