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

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.

Study Overview

• Status: Completed
• Conditions: Crowded Teeth; Malocclusion, Angle Class I
• Intervention / Treatment: Procedure: periodontally accelerated osteogenic orthodontics

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement; Other Names: PAOO
No Intervention: Traditional orthodontics; Patients in this group will undergo traditional orthodontics without any surgical interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Alignment	The time required in days will be calculated from the beginning of treatment till the end of the alignment stage	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
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.	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
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.	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
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.	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in Lower Incisors' Inclination	The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured.	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
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.	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
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.	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Change in the naso-labial angle	It is the angle formed between the lower border of the nose and the upper lip.	T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Issam Khoury, DDS MSc PhD, Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA; Principal Investigator: Hallaj I Alsino, DDS, MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2018
• Primary Completion (Actual): January 10, 2021
• Study Completion (Actual): June 20, 2021

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I
• Other Study ID Numbers: UDDS-Ortho-17-2018

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