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Acceleration of Alignment of Crowded Lower Anterior Teeth

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03659097
Enrollment
38
Registered
2018-09-06
Start date
2018-09-02
Completion date
2021-06-20
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crowded Teeth, Malocclusion, Angle Class I

Brief summary

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.

Interventions

PROCEDUREperiodontally accelerated osteogenic orthodontics

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of AlignmentThe 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 monthsThe time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Change in Little's Index of IrregularityT0: 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 monthsThe 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.
Change in Alveolar DefectT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsUsing 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

MeasureTime frameDescription
Change in the positioning of the upper lipT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsIt 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.
Change in inter-canine widthT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsThe 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
Change in the naso-labial angleT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsIt is the angle formed between the lower border of the nose and the upper lip.
Change in the positioning of the lower lipT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsIt 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.
Change in Alveolar Bone ThicknessT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsWill 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.
Change in Lower Incisors' InclinationT1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 monthsThe angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026