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

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ClinicalTrials.gov Identifier: NCT02816489
Recruitment Status : Unknown
Verified May 2016 by Mansoura University.
Recruitment status was:  Recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.


Condition or disease Intervention/treatment Phase
Labial Alveolar Bone Thickness Apical Root Resorption Device: Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA Device: Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: A Randomized Clinical Trial to Evaluate Labial Alveolar Bone Thickness and Apical Root Resorption Between Two Kinds of Brackets Using CBCT
Study Start Date : May 2016
Estimated Primary Completion Date : January 2017

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 Name: 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 Name: Gemini




Primary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816489


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

Locations
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Egypt
Recruiting
Mansoura, Egypt
Contact: Nader Giacaman, Master student    00201100769353    thevictoryspirit@hotmail.com   
Sponsors and Collaborators
Mansoura University

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT02816489     History of Changes
Other Study ID Numbers: 9046380
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Root Resorption
Tooth Resorption
Tooth Diseases
Stomatognathic Diseases