Acceleration of Alignment of Crowded Lower Anterior Teeth

NCT03659097 | Completed DMC

• 1 other identifier: UDDS-Ortho-17-2018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class I; Crowded Teeth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in inter-canine width

  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

  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

  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

  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

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

Study Arms (2)

Periodontally accelerated osteogenic orthodontics

EXPERIMENTAL

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

Procedure: periodontally accelerated osteogenic orthodontics

Traditional orthodontics

NO INTERVENTION

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

Interventions

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

Also known as: PAOO

Periodontally accelerated osteogenic orthodontics

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (5)

• 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.

  PMID: 27034749 BACKGROUND

• 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.

  PMID: 27903250 BACKGROUND

• 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.

  PMID: 24036771 BACKGROUND

• 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.

  PMID: 18533317 BACKGROUND

• 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.

  PMID: 24455038 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class I; Crowding

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior

Study Officials

• Hallaj I Alsino, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: September 2, 2018
• Primary Completion: January 10, 2021
• Study Completion: June 20, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)