N/A
Completed N=35
Micro-osteoperforations and Tooth Movement
Malocclusion
Source: ClinicalTrials.gov NCT02473471 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: 3D Digital Model Measurements of Canine Rate of Tooth Movement — 0.65; 0.67 mm — p=0.77
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3D Digital Model Measurements of Canine Rate of Tooth Movement |
1.93; 1.88 | 0.76 |
| PRIMARY Intra Oral Measurements of Canine Rate of Tooth Movement |
3.18; 3.26 | 0.74 |
| SECONDARY Root Resorption |
19.96; 19.66; 19.35; 18.93 | 0.59 |
| SECONDARY Pain Intensity |
1.4; 1.0; 2.4; 1.5; 2.6; 1.6 | 0.388 |
| SECONDARY Pain Interference /Pain During Eating? |
3.10; 2.00; 1.03; 0.65; 0.29; 0.19 | 0.09 |
| SECONDARY Pain Interference /Pain Interrupted Sleep |
0.58; 0.19; 0.13; 0.03; 0.06; 0.00 | 0.27 |
| SECONDARY Pain Interference /Swelling of the Surgical Side |
1.23; 0.41; 0.48; 0.26; 0.26; 0.00 | 0.05 |
| SECONDARY Pain Interference /Discomfort |
2.10; 1.29; 0.77; 0.58; 0.23; 0.10 | 0.18 |
| SECONDARY Patient Satisfaction |
8.94 | < 0.05 sig |
| SECONDARY Menstrual Cycle |
— | — |
Eligibility Criteria
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
- 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.
- Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base.
- A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible.
- 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.
- Lower anterior facial height(LAFH)
- Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.
Data sourced from ClinicalTrials.gov (NCT02473471). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.