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

June 27, 2016 updated by: Mansoura University

A Randomized Clinical Trial to Evaluate Labial Alveolar Bone Thickness and Apical Root Resorption Between Two Kinds of Brackets Using CBCT

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. Standardized upper and lower study casts.
  2. Standardized periapical radiograph.
  3. Standardized extra-oral and intra-oral photographs.
  4. 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.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I

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).
Device: Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA
(passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner)
Other Names:
  • Clarity SL
Experimental: Group II

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).
Device: Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA
(conventional stainless steel orthodontic brackets ligated with elastomeric ligature)
Other Names:
  • Gemini

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labial alveolar bone thickness
Time Frame: Change from baseline in Labial alveolar bone thickness at 6 months
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.
Change from baseline in Labial alveolar bone thickness at 6 months
Apical root resorption
Time Frame: Change from baseline in Apical root resorption at 6 months
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).
Change from baseline in Apical root resorption at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9046380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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