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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04778241
Enrollment
32
Registered
2021-03-03
Start date
2020-06-01
Completion date
2021-03-15
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Position Anomalies

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

Detailed description

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).

Interventions

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.

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Alignment efficiency4 weeks3D 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

MeasureTime frameDescription
The amount of Root resorption12 weeksThe 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.
Pain perceptionfirst 7 daysEvaluations 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.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026