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Completed

NCT Number: NCT04778241

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

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

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Key information

Conditions

Tooth Position Anomalies

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentisry-University of Baghdad

Baghdad, Iraq

About this study

Primarily the present study is designed to evaluate the efficacy of micro-osteoperation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth. Additionally, the possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.

Subjects and Methods: Orthodontic patients aged 17-25 years old, non-extraction treatment with lower anterior crowding of 4-6 mm using Little's irregularity index. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment will be tested using t-test, while root resorption and pain perception will be tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: MOP

Primary outcomes

  1. Alignment efficiency

    Time frame: 4 weeks

    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.

  2. Alignment efficiency

    Time frame: 8 weeks

    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.

  3. Alignment efficiency

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. The amount of Root resorption

    Time frame: 12 weeks

    The amount of root resorption was measured at the start of treatment and after 12 weeks, the length of the root was recoded at these time intervals. Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds.

  2. Pain perception

    Time frame: first 7 days

    Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10-point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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