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

NCT ID: NCT02816489

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31

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:

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.

Conditions

Labial Alveolar Bone Thickness; Apical Root Resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA

Intervention Type: DEVICE

(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 (3M Unitek - USA).

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

Group Type: EXPERIMENTAL

Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA

Intervention Type: DEVICE

(conventional stainless steel orthodontic brackets ligated with elastomeric ligature)

Interventions

Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA

(passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner)

Intervention Type: DEVICE

Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA

(conventional stainless steel orthodontic brackets ligated with elastomeric ligature)

Intervention Type: DEVICE

Other Intervention Names

Clarity SL; Gemini

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dr. Shaza M. Hammad, Associate Professor

Role: CONTACT

shazamohammad@yahoo.com

00201014910066

Facility Contacts

Nader Giacaman, Master student

Role: primary

thevictoryspirit@hotmail.com

00201100769353

Other Identifiers

9046380

Identifier Type: -

Identifier Source: org_study_id