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CompletedNCT03659097Updated Aug 19, 2021

Acceleration of Alignment of Crowded Lower Anterior Teeth

An interventional study of periodontally accelerated osteogenic orthodontics in Malocclusion, Angle Class I and Crowded Teeth, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2021-08-19.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 28 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malocclusion, Angle Class I
  • Crowded Teeth
03

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's enrollment of 38 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Bi-maxillary severe dental protrusion.
  • Previous orthodontic treatment.
  • Subject with psychological abnormalities.
  • Subject with systemic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Periodontally accelerated osteogenic orthodontics

    Patients in this group will undergo orthodontic treatment plus periodontally accelerated osteogenic orthodontics in order to induce tooth movement.

    Procedure: periodontally accelerated osteogenic orthodontics

  • No intervention
    Traditional orthodontics

    Patients in this group will undergo traditional orthodontics without any surgical interventions

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

    Also known as: PAOO

06

What researchers measure

Primary outcomes

  1. Duration of Alignment

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

    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

  2. Change in Little's Index of Irregularity

    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.

    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

  3. Change in Alveolar Defect

    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.

    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

Secondary outcomes

  1. Change in inter-canine width

    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

    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

  2. Change in Alveolar Bone Thickness

    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.

    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

  3. Change in Lower Incisors' Inclination

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

    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

  4. Change in the positioning of the upper lip

    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.

    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

  5. Change in the positioning of the lower lip

    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.

    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

  6. Change in the naso-labial angle

    It is the angle formed between the lower border of the nose and 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

07

Study locations

1 site
  • Department of Orthodontics, University of Damascus Dental School
    Damascus, DM20AM18, Syrian Arab Republic
08

References and documents

Publications

  • Munoz F, Jimenez C, Espinoza D, Vervelle A, Beugnet J, Haidar Z. Use of leukocyte and platelet-rich fibrin (L-PRF) in periodontally accelerated osteogenic orthodontics (PAOO): Clinical effects on edema and pain. J Clin Exp Dent. 2016 Apr 1;8(2):e119-24. doi: 10.4317/jced.52760. eCollection 2016 Apr. PubMed 27034749 ↗
  • Bahammam MA. Effectiveness of bovine-derived xenograft versus bioactive glass with periodontally accelerated osteogenic orthodontics in adults: a randomized, controlled clinical trial. BMC Oral Health. 2016 Nov 30;16(1):126. doi: 10.1186/s12903-016-0321-x. PubMed 27903250 ↗
  • Yu H, Jiao F, Wang B, Shen SG. Piezoelectric decortication applied in periodontally accelerated osteogenic orthodontics. J Craniofac Surg. 2013;24(5):1750-2. doi: 10.1097/SCS.0b013e3182902c5a. PubMed 24036771 ↗
  • Nowzari H, Yorita FK, Chang HC. Periodontally accelerated osteogenic orthodontics combined with autogenous bone grafting. Compend Contin Educ Dent. 2008 May;29(4):200-6; quiz 207, 218. PubMed 18533317 ↗
  • Amit G, Jps K, Pankaj B, Suchinder S, Parul B. Periodontally accelerated osteogenic orthodontics (PAOO) - a review. J Clin Exp Dent. 2012 Dec 1;4(5):e292-6. doi: 10.4317/jced.50822. eCollection 2012 Dec 1. PubMed 24455038 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03659097
Responsible party
Sponsor
First posted
Sep 6, 2018
Start date
Sep 2, 2018
Primary completion
Jan 10, 2021
Completion
Jun 20, 2021
Last update
Aug 19, 2021

Study contacts

Hallaj I Alsino, DDS
principal investigator · MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Mohammad Y Hajeer, DDS MSc PhD
study director · Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Issam Khoury, DDS MSc PhD
study director · Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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