Micro-osteoperforations and Tooth Movement

NCT02473471 | Completed Results

• 1 other identifier: JordanUST
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

Micro-Osteoperforation (MOPs); regional acceleratory phenomenon (RAP); Malocculsion

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (8)

• Root Resorption

  Baseline to 3rd month

• Pain Intensity

  within 7 days after the intervention

• Pain Interference /Pain During Eating?

  within 7 days after the intervention

• Pain Interference /Pain Interrupted Sleep

  within 7 days after the intervention

• Pain Interference /Swelling of the Surgical Side

  within 7 days after the intervention

Study Arms (2)

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.

Device: Micro-osteoperforation

control side

NO INTERVENTION

No intervention in the other side of maxilla (control side)

Interventions

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.

Also known as: Selective alveolar decortication

MOP side

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (1)

• 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.

  PMID: 29853235 DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Limitations and Caveats

1. Effect of intervention on inflammatory markers was not evaluated. 2. Short-term clinical study with only 3-months follow up period. 3. Most of the study subjects were females (75%).

Results Point of Contact

• Title: Dr.Amal Alkebsi
• Organization: Jordanian University of science and Technology

amalkibsi@gmail.com,aalkebsi13@den.just.edu.jo

00966552358684

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MClindent in Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: June 16, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 28, 2017
• Results First Posted: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: As soon as it published and it to be available anytime.
• Access Criteria: Official departments of recognized universities

Locations

JO (1)