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

NCT05132764 | Unknown

• 1 other identifier: EC : 2021-06-070
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontics

Keywords

Microosteoperforations; Little's index; Rate of tooth movement

Outcome Measures

Primary Outcomes (1)

• Rate of alignment of lower anterior teeth

  Rate of alignment of lower anterior teeth

  6 months

Secondary Outcomes (1)

• clinical crown length

  6 moths

Study Arms (2)

MOPs group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Microosteoperforations PROCEDURE

2 inter radicular bone microosteoperforations using temporary anchorage device tip.

MOPs group

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Missing lower anterior tooth.
• Systemic diseases/Medications affecting bone biology.
• Previous orthodontic treatment.
• Poor oral hygiene status.
• Active periodontal disease
• Syndromes

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Study Sites (1)

Sohrab Shaheed

Peshawar, KPK, 25100, Pakistan

RECRUITING

Study Officials

• Muhammad K Asif, PhD

  Rehman Medical Institute

  STUDY DIRECTOR

Central Study Contacts

Shahida Jehan, BDS

CONTACT

03438901267; shahida.jehan@rmi.edu.pk

Sohrab Shaheed, FCPS

CONTACT

03339327608; sohrab.shaheed@rmi.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessor and the investigator will have no knowledge of the intervention in the digital models.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Two parallel arm randomized controlled clinical trial

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: November 24, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)