ClinicalTrials.gg
Status unknownNCT02816489Updated Jun 28, 2016

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

An interventional study of Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA and Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA in Labial Alveolar Bone Thickness and Apical Root Resorption, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 14 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-28.

Sponsored by Mansoura University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
14 Years to 20 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Labial Alveolar Bone Thickness
  • Apical Root Resorption

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03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

This study's planned enrollment of 21 is below the median of 29 across 36 interventional studies indexed under Root Resorption.

Browse Root Resorption studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceClarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA

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

    Also known as: Clarity SL

  • DeviceGemini MBT brackets; 3M Unitek, Monrovia, CA, USA

    (conventional stainless steel orthodontic brackets ligated with elastomeric ligature)

    Also known as: Gemini

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline in Labial alveolar bone thickness at 6 months

  2. 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).

    Time frame: Change from baseline in Apical root resorption at 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2016 and a primary completion of Jan 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2016
First posted
Jun 28, 2016
Start
May 2016
Primary completionEst.
Jan 2017
Last update
Jun 28, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02816489
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
May 2016
Primary completion
Jan 2017 (estimated)
Last update
Jun 28, 2016

Study contacts

Dr. Shaza M. Hammad, Associate Professor
Contact
shazamohammad@yahoo.com
00201014910066

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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