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Effectiveness of Two Corticotomy Techniques in Retracting the Upper Anterior Teeth by Using Miniscrews

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ClinicalTrials.gov Identifier: NCT03279042
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

This study aims to evaluate and compare the skeletal, dental and soft tissue changes, the levels of pain and discomfort and the effect on periodontal health and teeth vitality associated to traditional corticotomy and flapless corticotomy in the retraction of upper anterior teeth.

40 patients requiring extraction of maxillary first premolars and maximum anchorage to retract the upper anterior teeth will participate in the study. They will be divided randomly into two groups : flapless corticotomy (20 patients) and traditional corticotomy (20 patients). Pre-retraction, corticotomy will be performed in the maxillary anterior segment. The skeletal, dental and soft tissue changes will be performed using lateral cephalometric radiographs which will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth and we will also use the dental casts to evaluate the dental changes.


Condition or disease Intervention/treatment Phase
Class II Div 1 Malocclusion Protrusion, Incisor Procedure: Flapless corticotomy surgical intervention will be conducted Procedure: Traditional corticotomy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Efficacy of Conventional Corticotomy Versus Flapless Corticotomy in the En-Masse Retraction of Upper Anterior Teeth : A Randomized Controlled Trial
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : August 12, 2017
Actual Study Completion Date : May 15, 2018

Arm Intervention/treatment
Experimental: Flapless corticotomy
Flapless corticotomy will be conducted in this group of patients.
Procedure: Flapless corticotomy surgical intervention will be conducted
Piezocision will be used to perform the procedure

Active Comparator: Traditional corticotomy
Traditional corticotomy will be performed in this group.
Procedure: Traditional corticotomy
Here the surgery involves elevation of flaps and then conducting the surgical intervention using piezo-surgery cutting saws.




Primary Outcome Measures :
  1. Duration of en-masse retraction of anterior teeth [ Time Frame: The months required to compete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group. ]
    Assessment will be performed by calculating the months required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.

  2. Rate of retraction [ Time Frame: The calculation of the rate of retraction will be done once the retraction procedures has finished. Completion of this procedure is expected to occur within 6 months in the experimental group and 8 months in the control group. ]
    Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.

  3. Change in Incisors' positions [ Time Frame: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group) ]
    Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken at monthly intervals until the end of the retraction phase.

  4. Change in Molars' positions [ Time Frame: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group) ]
    Amount of distance being traveled by the first molars and is going to be measured on study models taken at monthly intervals until the end of the retraction phase.

  5. Change in the SNA angle [ Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group. ]
    This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  6. Change in the SNB angle [ Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group. ]
    This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  7. Change in the ANB angle [ Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group. ]
    This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  8. Change in the SN.GoMe angle [ Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group. ]
    This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  9. Change in the MM angle [ Time Frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group. ]
    This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.


Secondary Outcome Measures :
  1. Change in the levels of pain and discomfort [ Time Frame: Levels of pain will be assessed at : 24 hours following the surgical intervention (T1), one week (T2) , two weeks (T3) and four weeks (T4) following the surgical intervention ]
    Assessment will be performed using questionnaires via visual analog scales (VAS)

  2. Change in the Plaque index [ Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group. ]
    The plaque index will be used to assess the status of the oral hygiene in these patients.

  3. Change in the Gingival index [ Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group. ]
    The Gingival index will be used to assess the status of the gingival tissues around the teeth.

  4. Change in the Bleeding index [ Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group. ]
    The plaque index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth.

  5. Gingival Recession [ Time Frame: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group. ]
    This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.

  6. Change in Tooth Vitality [ Time Frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group. ]
    Tooth vitality will be evaluated for each tooth of the six anterior teeth using Ethyl Chloride applied by a cotton roll.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with permanent occlusion at age 18-30 years.
  • Comprehensive medical and dental history ruling out any systemic disease
  • Not under any systemic medication.
  • No previous orthodontic treatment
  • Patients with satisfactory periodontal health and Good oral hygiene
  • Need to orthodontic treatment with fixed appliances
  • No congenitally missing teeth except third molars in the maxillary arch
  • Mild or no anterior crowding in maxillary arch.
  • Maximum anchorage, with 75% to 100% of space closure of retraction of anterior segment in maxillary arch.
  • Therapeutic extraction of maxillary first premolars required.
  • Patients with class Ⅱ division 1 (ANB angle ≤7 degrees) with severe overjet (5-10 mm)
  • Maximum retraction of the anterior teeth was desired.

Exclusion Criteria:

  • Patients with previous orthodontic treatment.
  • Patients with severe skeletal dysplasia in all three dimensions.
  • Patients suffer from systemic diseases or syndromes
  • Patients on medication for systemic disorders, pregnancy or steroid therapy.
  • Patients showing any signs of active periodontal disease
  • Patients with severe crowding (≥ 3.5 mm) in maxillary arch
  • Patients with missing or extracted teeth in maxillary arch except third molar.

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): NCT03279042


Locations
Syrian Arab Republic
Department of Orthodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
Principal Investigator: Hanin Nizar Khlef, DDS MSc student, Department of Orthodontics, University of Damascus Dental School, Syria
Study Director: Mohammad Y Hajeer, DDS MSc Phd Associate Professor of Orthodontics, University of Damascus Dental School, Syria
Study Director: Omar Hashmeh, DDS MSc PhD Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Syria

Publications:

Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT03279042     History of Changes
Other Study ID Numbers: UDDS-Ortho-04-2017
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Damascus University:
En masse retraction
Corticotomy
Acceleration of tooth movement
Piezocision
Flapless corticotomy
Class II division 1 malocclusion
Protrusion of upper incisors
Sliding mechanics
mini-implant based anchorage
temporary anchorage devices

Additional relevant MeSH terms:
Malocclusion
Malocclusion, Angle Class II
Overbite
Tooth Diseases
Stomatognathic Diseases