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Completed

NCT Number: NCT03659097

Acceleration of Alignment of Crowded Lower Anterior Teeth

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.

The aim of this study is to compare two groups of patients with moderate crowding of the lower anterior teeth First group (Experimental): the patients in this group will be treated with orthodontic fixed appliances + surgery to the alveolus of the lower anterior teeth in order to induce remodeling of the bony structures and enhance orthodontic movement.

Second group (Control): the patients in this group will be treated using fixed appliances with any acceleration method.

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Key information

Conditions

Malocclusion, Angle Class I Behavior Crowded Teeth Crowding Malocclusion Spatial Behavior Stomatognathic Diseases Tooth Diseases

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Class I malocclusion with moderate crowding (4-6 mm of tooth-size-arch-length-discrepancy).
  • Good oral hygiene and periodontal health.
  • No severe skeletal discrepancy.
  • Normal inclination for the upper and lower incisors.
  • No congenitally missing or extracted teeth (except for the third molars).

Exclusion criteria

  • Bi-maxillary severe dental protrusion.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.

Treatment and study plan

periodontally accelerated osteogenic orthodontics

Procedure

Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement

Other names: PAOO

Primary outcomes

  1. Duration of Alignment

    Time frame: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 5 to 6 months

    The time required in days will be calculated from the beginning of treatment till the end of the alignment stage

  2. Change in Little's Index of Irregularity

    Time frame: T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months

    The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding.

    The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.

  3. Change in Alveolar Defect

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    Using cone-beam computed tomography (CBCT), each tooth root will be evaluated in axial and cross-sectional slices at the buccal and lingual surfaces. When no cortical bone is observed around the root in at least three sequential views, this will be considered an alveolar defect. If the alveolar bone height is more than 2 mm from the cemento-enamel junction, it will be classified as dehiscence ,When the defect does not involve the alveolar crest, this case will be classified as fenestration.

    The status of the alveolar bone will be assessed twice.

Secondary outcomes

  1. Change in inter-canine width

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    The distance between the cusp tips of the lower canines. This variable will be measured on plaster models.

    T1: One day before the beginning of treatment; T2: at the end of the alignment stage

  2. Change in Alveolar Bone Thickness

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    Will be measured for each of the lower anterior teeth in the cervical, middle, and apical regions. This will be achieved by using the ruler which will be positioned perpendicular to tooth long axis from the root surface (without measuring the periodontal ligament ) to the most external surface of the cortical bone.

  3. Change in Lower Incisors' Inclination

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured.

  4. Change in the positioning of the upper lip

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    It is going to be evaluated by Ricketts' analysis (E-Line). This is done by drawing a reference line between the tip of the nose and the most prominent point on the chin contour (Pogonion).

    The distance of the upper lip from this line is a measure of lip positioning.

  5. Change in the positioning of the lower lip

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    It is going to be evaluated by Ricketts' analysis (E-Line). This is done by drawing a reference line between the tip of the nose and the most prominent point on the chin contour (Pogonion).

    The distance of the lower lip from this line is a measure of lower lip positioning.

  6. Change in the naso-labial angle

    Time frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

    It is the angle formed between the lower border of the nose and the upper lip.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Efficacy of Periodontally Accelerated Osteogenic Orthodontics in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Two-Arm Randomized Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2018
Registry last updated
Aug 19, 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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