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Acceleration of Alignment of Crowded Lower Anterior Teeth

Primary Purpose

Malocclusion, Angle Class I, Crowded Teeth

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
periodontally accelerated osteogenic orthodontics
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Periodontally accelerated osteogenic orthodontics

Traditional orthodontics

Arm Description

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

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

Outcomes

Primary Outcome Measures

Duration of Alignment
The 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 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.
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.

Secondary Outcome Measures

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
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.
Change in Lower Incisors' Inclination
The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured.
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.
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.
Change in the naso-labial angle
It is the angle formed between the lower border of the nose and the upper lip.

Full Information

First Posted
September 3, 2018
Last Updated
August 17, 2021
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03659097
Brief Title
Acceleration of Alignment of Crowded Lower Anterior Teeth
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class I, Crowded Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontally accelerated osteogenic orthodontics
Arm Type
Experimental
Arm Description
Patients in this group will undergo orthodontic treatment plus periodontally accelerated osteogenic orthodontics in order to induce tooth movement.
Arm Title
Traditional orthodontics
Arm Type
No Intervention
Arm Description
Patients in this group will undergo traditional orthodontics without any surgical interventions
Intervention Type
Procedure
Intervention Name(s)
periodontally accelerated osteogenic orthodontics
Other Intervention Name(s)
PAOO
Intervention Description
Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement
Primary Outcome Measure Information:
Title
Duration of Alignment
Description
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
Title
Change in Little's Index of Irregularity
Description
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
Title
Change in Alveolar Defect
Description
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 Outcome Measure Information:
Title
Change in inter-canine width
Description
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
Title
Change in Alveolar Bone Thickness
Description
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
Title
Change in Lower Incisors' Inclination
Description
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
Title
Change in the positioning of the upper lip
Description
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
Title
Change in the positioning of the lower lip
Description
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
Title
Change in the naso-labial angle
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hallaj I Alsino, DDS
Organizational Affiliation
MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Issam Khoury, DDS MSc PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27034749
Citation
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.
Results Reference
background
PubMed Identifier
27903250
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. doi: 10.1186/s12903-016-0321-x.
Results Reference
background
PubMed Identifier
24036771
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.
Results Reference
background
PubMed Identifier
18533317
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.
Results Reference
background
PubMed Identifier
24455038
Citation
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.
Results Reference
background

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Acceleration of Alignment of Crowded Lower Anterior Teeth

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