N/A N=35 Randomized Double-blind Treatment

Micro-osteoperforations and Tooth Movement

Malocclusion

Bottom Line

View on ClinicalTrials.gov: NCT02473471 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: 3D Digital Model Measurements of Canine Rate of Tooth Movement — 0.65; 0.67 mm — p=0.77

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Micro-osteoperforation (Device)
Age: Pediatric, Adult · 16+ yrs
Sex: All
Sponsor: Jordan University of Science and Technology
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY 3D Digital Model Measurements of Canine Rate of Tooth Movement	1.93; 1.88	0.76
PRIMARY 3D Digital Model Measurements of Canine Rate of Tooth Movement	1.93; 1.88	0.76
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
PRIMARY Intra Oral Measurements of Canine Rate of Tooth Movement	3.18; 3.26	0.74
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	—	—

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.

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.

View full record on ClinicalTrials.gov →

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.