Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: (MOP)

October 26, 2021 updated by: University of Malaya

Duration Of Lower Labial Segment Alignment With Repeated Micro-Osteoperforations: Randomised Controlled Clinical Trial

The main purpose is to compare overall alignment time (OAT) in days in alleviating mandibular incisors crowding between control group and MOPs group.Furthermore, to investigate the presence of volumetric root resorption from CBCT, gingival recession and formation of black triangle post lower labial segment alignment between micro-osteoperforations group and control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prolonged treatment time in orthodontics is an undesirable side effect for both the patient and clinician. Usually, an average course of comprehensive orthodontic treatment with fixed appliances requires less than 2 years to complete (19.9 months). This prolonged treatment time may cause adverse effects such as root resorption, gingival recession, caries & enamel demineralization. Micro-osteoperforations is safe, minimally invasive technique which perforations are performed through the gum tissues, penetrating the bone without the need to raise a flap.Control group will not received any MOP and will receive standard orthodontic treatment.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kajang, Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry , University of Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gender : Male and Female
  • Age range : ≥ 18years to 45 years old
  • Crowding of 3mm - 7mm on lower labial segment (lower right canine to lower left canine) which does not require extractions in the lower arch
  • Class II div I Incisor relationship with extraction of both upper 1st premolars
  • Maximum anchorage control with temporary anchorage device ( TAD) , with Molar Class II (¼ to full unit) malocclusion
  • Average vertical facial proportions
  • No systemic disease
  • Acceptable good oral hygiene
  • No periodontal disease

Exclusion Criteria:

  • Smokers
  • Distally angulated canines
  • History of trauma (crown fracture or avulsion and re-implantation) , endodontic treatment
  • Missing permanent mandibular anterior teeth ( Hypodontia) / Retained deciduous teeth in mandibular anterior area
  • Habits eg: fingernails biting , toothpick user , using hard toothbrush
  • Vertical skeletal discrepancies eg high angle and low angle
  • Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
  • Poor oral hygiene for more than 3 visits
  • Current periodontal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micro-osteoperforations
Lower arch, 2 MOPs vertically at interdental area bilaterally mesial to lower 6's ; mesial to lower 1st premolar; mesial to lower 2's and between the lower 1's..The start date of lower labial segment alignment (T1) was recorded after insertion of the lower 0.014'' NiTi archwire. Participants were reviewed every 6 weeks and repeated MOPs were performed for the experimental group until the completion of lower labial segment alignment (LLS), which is when the Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine.
Device: Micro-osteoperforations
MOPs will be performed using SIA Excalibur Mini-Implant with dimension 1.6 mm in width and length of 6 mm, screw 3 mm depth into buccal bone of intervention sites
No Intervention: control
Conventional orthodontic treatment without any aid in tooth acceleration method / device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the conventional (control group).
Time Frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
5 months
2. To compare the duration to align the lower labial segment (33-43), between regular and irregular review groups from the micro-osteoperforations group.
Time Frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
5 months
3. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the regular review group.
Time Frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
5 months
4. To compare the duration to align the lower labial segment (33-43), between micro-osteoperforations and control group in the irregular review group.
Time Frame: 5 months
Total treatment time needed to achieved lower labial segment alignment until Little's irregularity index scores one, indicating a minimum irregularity of ≤ 2 mm contact point displacement, based on the contact point displacements of the mandibular anterior segment, from canine to canine
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume of root resorption with micro-osteoperforations group vs the control group
Time Frame: 5 months
Total volume of root resorption in cubic millimeter (mm3) using 3D Cone Beam CT imaging scanner compare at baseline and end of LLS alignment
5 months
Gingival recession between micro-osteoperforations and control group.
Time Frame: 5 months
Gingival recession assessed in millimetre (mm) from cement-enamel junction (CEJ) to free gingival margin using electric digital calliper with an accuracy of 0.01mm, at baseline and end LLS alignment
5 months
Black triangle between micro-osteoperforations and control group.
Time Frame: 5 months
Presence of black triangle for interdental at baseline and end of LLS alignment
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Nik Nuraini Nik Azmin, University Malaya
  • Principal Investigator: lorretha p ringgingon, faculty of dentistry university of malaya
  • Study Director: Saritha Sivarajan, faculty of dentistry university of malaya
  • Study Director: wey mang chek, faculty of dentistry university of malaya
  • Study Director: mona fayed, faculty of dentistry university of malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2018

Primary Completion (Actual)

April 14, 2021

Study Completion (Actual)

April 14, 2021

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGD170005

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malocclusion

Clinical Trials on Micro-osteoperforations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe