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Evaluation of Self-ligating Brackets Plus Minor Surgery in Treating Crowded Cases of Malocclusion

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ClinicalTrials.gov Identifier: NCT03647241
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.

The aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth:

  • Group 1 : Patients will be treated using self-ligating brackets
  • Group 2 : Patients will be treated using self-ligating brackets associated with flapless corticotomy.
  • Group 3 : Patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth)

At the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) Also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.


Condition or disease Intervention/treatment Phase
Malocclusion of Anterior Teeth Device: Self-Ligating Brackets Device: Traditionally-Ligated Brackets Procedure: Corticotomy Not Applicable

Detailed Description:

The sample of this study will be chosen according the following steps:

  • The examination of patients referred to the Department of Orthodontics at the University of Damascus Dental School (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial.
  • A random sample of 100 patients from the sampling frame will be chosen.
  • An information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. Then consent forms will be collected from those who agree to participate.
  • A random selection of 60 patients will be performed. Then a random distribution of these patients to 3 groups will be done.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Efficacy of Self-Ligating Brackets Alone Or In Combination With Flapless Corticotomy In Leveling And Aligning Severely Crowded Dental Arches Compared With Conventional Brackets: A Randomized Clinical Controlled Trial
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : November 10, 2019
Estimated Study Completion Date : February 19, 2020

Arm Intervention/treatment
Experimental: Self-Ligating Brackets
Patients will be treated using self-ligating brackets to achieve proper alignment of teeth
Device: Self-Ligating Brackets
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Other Name: SLBs

Experimental: Self-Ligating Brackets with Corticotomy
Patients will be treated using self-ligating brackets with corticotomy (alveolar cortical cuts) in order to accelerate orthodontic treatment.
Device: Self-Ligating Brackets
These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
Other Name: SLBs

Procedure: Corticotomy
Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.
Other Names:
  • Piezosurgery
  • Decortication

Active Comparator: Traditionally-Ligated Brackets
Patients in this group will be treated using traditionally-ligated brackets to achieve proper alignment of teeth
Device: Traditionally-Ligated Brackets
These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.
Other Name: Non-SLBs




Primary Outcome Measures :
  1. Duration of Alignment [ Time Frame: This variable is going to be measured at the end of the alignment stage (i.e. expected to occur within four to six months) ]
    The time required in days will be calculated from the beginning of treatment till the end of the alignment stage

  2. Change in Little's Index [ Time Frame: T0: one day before the beginning of treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months) ]
    The irregularity of the upper and lower incisors is calculated by measuring the amount of deviation of the anatomic contact points between the six incisors in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). The more the score is, the more crowded the case is.

  3. Change in inter-canine width lingually [ Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) ]
    The distance between the most lingual points on the lingual surface of the canines on the upper dental arch. This will be measured on plaster models.

  4. Change in inter-canine width [ Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) ]
    The distance between the cusp tips of the upper canines. This variable will be measured on plaster models.

  5. Change in Canine Rotation Angle [ Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) ]
    It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the canine.

  6. Change in Lateral Incisor Rotation Angle [ Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) ]
    It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the lateral incisor.

  7. Change in Central Incisor Rotation Angle [ Time Frame: T1: One day before the beginning of treatment; T2: at the end of the alignment stage (is expected within four to six months) ]
    It is calculated by the angle formed between the median palatine suture and the line passing through the two medial and lateral contact points of the central incisor.



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Ages Eligible for Study:   17 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of patients: 17-28 years.
  2. Severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction.
  3. The Little's Index of Irregularity is over 7 mm.
  4. There is no previous orthodontic treatment.
  5. The patient dose not take any drug may interfere with the tooth movement (Cortisone, NSAIDs, ...).
  6. The patient has good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness (1963).
  7. Class I or mild class II (ANB ≤ 5) or mild class III (ANB ≥ 0) skeletal relationship.
  8. Overbite is between 0-4 mm.
  9. There is no skeletal constriction on the upper jaw.
  10. Full presence of all permanent teeth in the dental arch (except for third molars)

Exclusion Criteria:

  1. Any systemic diseases that would affect tooth movement .
  2. Any congenital syndromes or cleft lip and palate cases
  3. Bad oral health

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): NCT03647241


Contacts
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Contact: Heba Al-Ibrahim, DDS +963994475217 ortho.hiba.alibrahim991@hotmail.com
Contact: Mohammad Y Hajeer, DDS MSc PhD +963940404840 myhajeer@gmail.com

Locations
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Syrian Arab Republic
Department of Orthodontics, University of Damascus Dental School Recruiting
Damascus, Syrian Arab Republic, DM20AM18
Contact: Mohammad Y Hajeer, DDS MSc PhD    +963940404840    myhajeer@gmail.com   
Principal Investigator: Heba Al-Ibrahim, DDS         
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Heba Al-Ibrahim, DDS MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Study Chair: Mohammad Y Hajeer, DDS MSc PhD Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Study Director: Issam Khoury, DDS MSc PhD Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

Publications:

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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03647241     History of Changes
Other Study ID Numbers: UDDS-Ortho-10-2018
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases