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

Tooth Position Anomalies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778241
• Other study ID #: MOP76
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: April 2021
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Position Anomalies

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Iraq	College of Dentisry-University of Baghdad	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The amount of Root resorption	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.	12 weeks
Secondary	Pain perception	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.	first 7 days