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Completed

NCT Number: NCT03888560

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

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry , University of Malaya

Kajang, Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micro-osteoperforations

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Acronym: MOP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2019
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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