Effect of Micro-osteo-perforations on the Rate of Alignment of Mandibular Anterior Teeth.

Micro osteoperforation is an easy, safe and effective method of accelerating orthodontic tooth movement by 2-3 times.it has been reported to increased the osteoblastic activity and some acceleration of the rate of canine retraction,reducing the treatment duration and associated side effects. The aim of this study is to assess the effect of MOPs on the rate of alignment of mandibular anterior teeth.

Study Overview

• Status: Recruiting
• Conditions: Orthodontics
• Intervention / Treatment: Procedure: Microosteoperforations

Detailed Description

MATERIAL AND METHODS:

STUDY DESIGN: Two parallel arm randomized controlled clinical trial SETTING: Orthodontics Department, Rehman College of Dentistry. DURATION OF STUDY: one year SAMPLING TECHNIQUE: non-probability consecutive sampling.

SAMPLE SELECTION:

INCLUSION CRITERIA

1. Malocclusion cases with mandibular anterior segment crowding.
2. Age range 13-30 years.

EXCLUSION CRITERIA:

1. Missing lower anterior tooth.
2. Systemic diseases/Medications affecting bone biology.
3. Previous orthodontic treatment.
4. Poor oral hygiene status.
5. Active periodontal disease
6. Syndromes. DATA COLLECTION Written informed consent from the patients will be taken after clarification of the purpose of the intervention and the associated risks and benefits. Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA). After bonding of lower arch the patients will be randomized into control and experimental groups.

Patients will be randomly allocated, through computer generated tables in Microsoft Excel Software, into parallel groups with a 1:1 allocation ratio. Allocation will be concealed in opaque envelopes and opened only at the time of intervention.

Local anesthesia will be given in lower arch on each side approximately 1cm from labial frenum. Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment, by bleeding points using a calibrated periodontal probe. Probe tip will be inserted to the level of bone to measure the thickness of gingiva. The measurement will be added to the depth of perforation needed i-e 2 - 3 mm into the bone. First point will be marked at a distance of 3mm from free gingival margin and second point will be marked 3mm from the first one. Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone. An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed. After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.

The control group will receive no MOPs at the alignment stage. Alignment will be started in both control and experimental groups using 0.012 NiTi (North American Braces, USA). Both the groups will be followed every month for maximum six months. Digital scan of lower arch will be taken on each visit. Each scan will be labelled for identification, date of scan taking and little index score .For reliability 20 randomly selected scan will be rescored for little index by the same examiner as well as another examiner after 2 weeks for intra and inter-examiner reliability.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shahida Jehan, BDS; Phone Number: 03438901267; Email: shahida.jehan@rmi.edu.pk
• Study Contact Backup: Name: Sohrab Shaheed, FCPS; Phone Number: 03339327608; Email: sohrab.shaheed@rmi.edu.pk

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25100
      • Recruiting
      • Sohrab Shaheed
      • Contact: Sohrab Shaheed, FCPS; Phone Number: 03339327608; Email: sohrab.shaheed@rmi.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Malocclusion cases with mandibular anterior segment crowding.
2. Age range 13-30 years.

Exclusion Criteria:

1. Missing lower anterior tooth.
2. Systemic diseases/Medications affecting bone biology.
3. Previous orthodontic treatment.
4. Poor oral hygiene status.
5. Active periodontal disease
6. Syndromes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOPs group; Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).Local anesthesia will be given in lower arch .Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment using a calibrated periodontal probe. Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone. An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed. After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.	Procedure: Microosteoperforations; 2 inter radicular bone microosteoperforations using temporary anchorage device tip.
No Intervention: Control group; Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).The control group will receive no MOPs at the alignment stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of alignment of lower anterior teeth	Rate of alignment of lower anterior teeth	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical crown length	clinical crown length	6 moths

Collaborators and Investigators

• Sponsor: Rehman Medical Institute - RMI
• Investigators: Study Director: Muhammad K Asif, PhD, Rehman Medical Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 13, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Rate of tooth movement; Microosteoperforations; Little's index
• Other Study ID Numbers: EC : 2021-06-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No