Acceleration of Alignment of Crowded Lower Anterior Teeth

Malocclusion, Angle Class I Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659097
• Other study ID #: UDDS-Ortho-17-2018
• Status: Completed
• Phase: N/A
• Start date: September 2, 2018
• Est. completion date: June 20, 2021

Study information

• Verified date: August 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 20, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowded Teeth
• Malocclusion
• Malocclusion, Angle Class I

Intervention

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

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

Munoz F, Jiménez 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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