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Labial Alveolar Bone Thickness and Apical Root Resorption Changes Associated With Self-ligating Versus Conventional Brackets

Primary Purpose

Labial Alveolar Bone Thickness, Apical Root Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA
Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Labial Alveolar Bone Thickness

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ranged between 14-20 years.
  2. Complete permanent dentition (excluding third molars).
  3. Angle Class I malocclusion.
  4. Crowding anteriorly ranging from 2 to 4 mm.
  5. Healthy young patients.

Exclusion Criteria:

  1. Patients with signs of apical root resorption detected at the first examination by periapical radiographs.
  2. Blocked-out or High-up canines.
  3. Patients who went to previous orthodontic treatment.
  4. Evidence of periodontal or gingival problems.
  5. Endodontic treatment.

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

will be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA). Intervention: Device: passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA).

will be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA). Intervention: Device: conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA).

Outcomes

Primary Outcome Measures

Labial alveolar bone thickness
Labial alveolar bone thickness will be measured in millimeters using CBCT at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels were set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness was assessed at the cervical level (L1) and midroot level (L2) at T0 and T1.
Apical root resorption
Apical root resorption will be measured in millimeters using CBCT by determining the difference in the total tooth length, which was measured from the incisal border to the root apex, between T0 and T1 (T1-T0).

Secondary Outcome Measures

Full Information

First Posted
May 30, 2016
Last Updated
June 27, 2016
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02816489
Brief Title
Labial Alveolar Bone Thickness and Apical Root Resorption Changes Associated With Self-ligating Versus Conventional Brackets
Official Title
A Randomized Clinical Trial to Evaluate Labial Alveolar Bone Thickness and Apical Root Resorption Between Two Kinds of Brackets Using CBCT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets. The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets.
Detailed Description
Labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets. Protocol submitted in partial fulfillment for the requirements of Master Degree in Orthodontics. The initial stage of treatment crowding permanent teeth orthodontically is worried about teeth leveling and alignment. The accuracy of this procedure depends on various variables. Friction is generated upon the materialistic composition of different bracket and archwire types, and the technique of ligature between them. Several self-ligating brackets have been grown since 1935. Self-ligation doesn't need for an elastomeric attachment to catch the archwire, so it is related with a highly reduced friction with many different types of archwires, therefore less force required. It is valuable to evaluate any appliance system for its capability to align teeth with minimal injurious effects to the oral tissues. The aim of this study will be to compare labial alveolar bone thickness and apical root resorption changes associated with self-ligating versus conventional brackets. Subjects and method Study design: Randomized controlled clinical trial Study setting and population: The sample of this study will be consisted of twenty one patients selected from Outpatient Clinic, Orthodontic Department, Faculty of Dentistry, Mansoura University. Interventions: The patients will be divided randomly into two groups and will be treated separately as follows: Group I: will be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner. Group II: will be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature. The patients will be treated orthodontically within the initial leveling and alignment for the 6 month duration beginning with the same sequence of 0.014, 0.016, 0.016 × 0.022 inch nickel-titanium archwires and 0.016 × 0.022 inch stainless-steel archwire. Each archwire will be remained for 1.5 months, and it will be replaced with the previously mentioned sequence. For group II, the archwires will be attached to the brackets by using an elastomeric ligature. CBCT will be obtained in two time intervals, before beginning the orthodontic treatment and 6 months after it. Dental stripping and extraction of premolars will be eliminated. Records: For all patients the following records will be taken before and after leveling and alignment: Standardized upper and lower study casts. Standardized periapical radiograph. Standardized extra-oral and intra-oral photographs. Standardized cone beam computed tomography (CBCT). Observations: Sagittal cuts of upper and lower incisors in the center of the long axis will be selected. The labial alveolar bone thickness (LABT) of each incisor will be determined at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels will be set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness will be assessed at the cervical level (L1) and midroot level (L2) at T0 and T1. Furthermore, the apical root resorption (ARR) will be calculated by determining the difference in the total tooth length, which will be measured in millimeters from the incisal border to the root apex, between T0 and T1 (T1-T0). Ethical consideration: All patients will receive information about the future clinical trial study and give their consent by signing an informed consent. Data management and analysis: All statistical analysis will be performed with SPSS software. Differences will be considered significant at P values less than 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labial Alveolar Bone Thickness, Apical Root Resorption

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
will be treated using passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA). Intervention: Device: passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner (3M Unitek - USA).
Arm Title
Group II
Arm Type
Experimental
Arm Description
will be treated using conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA). Intervention: Device: conventional stainless steel orthodontic brackets ligated with elastomeric ligature (3M Unitek - USA).
Intervention Type
Device
Intervention Name(s)
Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA
Other Intervention Name(s)
Clarity SL
Intervention Description
(passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner)
Intervention Type
Device
Intervention Name(s)
Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA
Other Intervention Name(s)
Gemini
Intervention Description
(conventional stainless steel orthodontic brackets ligated with elastomeric ligature)
Primary Outcome Measure Information:
Title
Labial alveolar bone thickness
Description
Labial alveolar bone thickness will be measured in millimeters using CBCT at the site neighboring to the widest point of the labiopalatal root in two levels separated by 3 mm (L1 and L2, respectively); these levels were set along the long axis of the incisor and located every 3 mm from the cementoenamel junction (CEJ) level. Labial alveolar bone thickness was assessed at the cervical level (L1) and midroot level (L2) at T0 and T1.
Time Frame
Change from baseline in Labial alveolar bone thickness at 6 months
Title
Apical root resorption
Description
Apical root resorption will be measured in millimeters using CBCT by determining the difference in the total tooth length, which was measured from the incisal border to the root apex, between T0 and T1 (T1-T0).
Time Frame
Change from baseline in Apical root resorption at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ranged between 14-20 years. Complete permanent dentition (excluding third molars). Angle Class I malocclusion. Crowding anteriorly ranging from 2 to 4 mm. Healthy young patients. Exclusion Criteria: Patients with signs of apical root resorption detected at the first examination by periapical radiographs. Blocked-out or High-up canines. Patients who went to previous orthodontic treatment. Evidence of periodontal or gingival problems. Endodontic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shaza M. Hammad, Associate Professor
Phone
00201014910066
Email
shazamohammad@yahoo.com
Facility Information:
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nader Giacaman, Master student
Phone
00201100769353
Email
thevictoryspirit@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Labial Alveolar Bone Thickness and Apical Root Resorption Changes Associated With Self-ligating Versus Conventional Brackets

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