Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding

NCT04778241 | Completed

• 1 other identifier: MOP76
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the present study is to evaluate the the efficacy of micro-osteoperforation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth

Conditions

Tooth Position Anomalies

Outcome Measures

Primary Outcomes (3)

• Alignment efficiency

  3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.

  4 weeks

• Alignment efficiency

  3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.

  8 weeks

• Alignment efficiency

  3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3D program (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.

  12 weeks

Secondary Outcomes (2)

• The amount of Root resorption

  12 weeks

• Pain perception

  first 7 days

Study Arms (2)

Micro-Osteoperforation group

EXPERIMENTAL

All the participants bonded by the care provider with 0.022 inch MBT prescription appliance (Ortho TechanologyTM,USA). Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible.

Procedure: Micro-osteoperforation

Control group

NO INTERVENTION

All the participants in this group bonded by the principal investigator with 0.022-inch slot MBT prescription appliance (Ortho TechanologyTM,USA). No micro-osteoperforation was used in this group.

Interventions

Micro-osteoperforation PROCEDURE

Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible.

Also known as: MOP

Micro-Osteoperforation group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age range between 17-25years
• Non-extraction treatment in the mandibular arch
• Presence of full complement of dentition from first molar to first molar
• Mandibular anterior irregularity index between 4-6 mm
• Patient with healthy periodontium and no attachment loss of \>2 mm

You may not qualify if:

• Previous orthodontic treatment
• Presence of primary or missing permanent teeth in the mandibular anterior area
• Medical problems that affect tooth movement.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentisry-University of Baghdad

Baghdad, Iraq

Location

Related Publications (1)

• Al-Attar A, Nissan L, Almuzian M, Abid M. Effect of mini-implant facilitated micro-osteoperforations on the alignment of mandibular anterior crowding: A randomised controlled clinical trial. J Orthod. 2022 Dec;49(4):379-387. doi: 10.1177/14653125221099038. Epub 2022 May 15.

  PMID: 35575069 DERIVED

Study Officials

• Mushriq Abid, MSc, PhD

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to treatment allocation was possible only for the investigator and data analyst because the clinicians could know the intervention as osteo-perforation can be obviously seen clearly. Masking the intervention for the participants were not possible because micro-osteoperforation is a surgical procedure. All the trial documents were labeled with the study ID number, which was used for participant identification and data collection without unmasking the allocation group. This allowed the investigator to complete data collection and measurements blindly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 3, 2021
• Study Start: June 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 15, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

IR (1)