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

NCT ID: NCT04778241

Last Updated: 2021-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Position Anomalies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Micro-Osteoperforation group

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.

Group Type EXPERIMENTAL

Micro-osteoperforation

Intervention Type 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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Micro-osteoperforation

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MOP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Previous orthodontic treatment
2. Presence of primary or missing permanent teeth in the mandibular anterior area
3. Medical problems that affect tooth movement.
Minimum Eligible Age

17 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mushriq F. Abid

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mushriq Abid, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

College of Dentisry-University of Baghdad

Baghdad, , Iraq

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iraq

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35575069 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MOP76

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mandibular First Molar Distalization
NCT04229797 NOT_YET_RECRUITING NA