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

Primary Purpose

Class II Div 1 Malocclusion, Protrusion, Incisor

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Flapless corticotomy surgical intervention will be conducted
Traditional corticotomy
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Div 1 Malocclusion focused on measuring 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

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flapless corticotomy

Traditional corticotomy

Arm Description

Flapless corticotomy will be conducted in this group of patients.

Traditional corticotomy will be performed in this group.

Outcomes

Primary Outcome Measures

Duration of en-masse retraction of anterior teeth
Assessment will be performed by calculating the months required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
Rate of retraction
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.
Change in Incisors' positions
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.
Change in Molars' positions
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.
Change in the SNA angle
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.
Change in the SNB angle
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.
Change in the ANB angle
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.
Change in the SN.GoMe angle
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.
Change in the MM angle
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

Change in the levels of pain and discomfort
Assessment will be performed using questionnaires via visual analog scales (VAS)
Change in the Plaque index
The plaque index will be used to assess the status of the oral hygiene in these patients.
Change in the Gingival index
The Gingival index will be used to assess the status of the gingival tissues around the teeth.
Change in the Bleeding index
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.
Gingival Recession
This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.
Change in Tooth Vitality
Tooth vitality will be evaluated for each tooth of the six anterior teeth using Ethyl Chloride applied by a cotton roll.

Full Information

First Posted
August 31, 2017
Last Updated
August 23, 2018
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03279042
Brief Title
Effectiveness of Two Corticotomy Techniques in Retracting the Upper Anterior Teeth by Using Miniscrews
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 12, 2016 (Actual)
Primary Completion Date
August 12, 2017 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A corticotomy is cutting of the bone involves cortical bone only, leaving intact the medullary vessels and periosteum It offers an advantage to adult patients in reduction the orthodontic treatment time. The definition of traditional corticotomy is: elevating full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth apices and connected by a horizontal corticotomy; this process is done on both the labial and palatal aspects. The definition of flapless corticotomy is: a minimally invasive version of corticotomy, using a piezotome in order to inflict bone injury. This technique entails labial and palatal interproximal piezoelectric microincisions into the cortical bone, without reflecting periodontal flaps. Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent. Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will be inserted between the maxillary second premolar and first molar at approximately 8-10mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the lateral incisors will be inserted. The surgery will be carried out under local anesthesia. The traditional corticotomy will be handled by the same maxillofacial surgeon and the flapless corticotomy will be handled by the same orthodontist. For traditional corticotomy, sulcular incisions the mesial aspect of one second premolar to the mesial surface of the contralateral second premolar will be placed, and full thickness flap will be elevated, 3 mm above the apical region of the tooth. piezoelectric under copious irrigation will be used for making vertical and horizontal cuts (only cortical surface). The vertical cuts will be between the dental roots in the interdental cortical surfaces ,stopping 2 mm short of the alveolar crest, occlusally. Horizontal cut will connect the vertical cuts 2 mm beyond root apex. These cuts will be performed from the mesial aspect of one second premolar to the mesial surface of the contralateral second premolar involving the anteriors. Similarly, a palatal flap incision will be raised immediately for doing the same vertical and horizontal cuts in the superficial surface of the palatal bone. For the flapless corticotomy, The depth of gingival tissue will be determined through bone sounding using a periodontal probe. A scalpel will be used to make the incisions through the gingiva, 4mm below the interdental papilla to preserve the coronal attached gingiva. These vertical incisions will be placed from the mesial aspect of one second premolar to the mesial surface of the contralateral second premolar on the labial and palatal aspects of the maxilla through the gingiva and the underlying bone. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1 mm within the cortical bone. Postoperatively, all patients will be advised to rinse with chlorhexidine mouthwash twice a day for one week. All patients will be contacted the day after the procedure to ensure no complications with surgery and will be followed up one month post-surgery to assess for signs of infection and ensure normal healing. We will assess patients' acceptance and the levels of pain and discomfort of traditional corticotomy and flapless corticotomy by asking all patients to fill out 4 questionnaires during the first month after the surgical procedure using a VAS. The surgical procedure will be performed and (250-300) g force will be applied on each side (3-4 days) after corticotomy using two NiTi springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks after the corticotomy . Retraction will be stopped when a class I canine relationship will be achieved and a good incisor relationship will be obtained. Periodontal health will be assessed at the beginning of orthodontic treatment, before and after corticotomy by evaluating the following parameters: plaque index, gingival index, bleeding index, and gingival recession. Dental casts will be used for the quantification of the anteroposterior movement of the anterior teeth and the first molars every 30 days until class I canine relationship will be achieved and a good incisor relationship will be obtained. To evaluate the movement of the anterior teeth: we will project the canine cusp on the median line and measure the distance from this point to the projected position of a distinct medial ruga point. To evaluate the movement of the first molars: we will project the mesial contact point of the first molar on the median line and measure the distance from this point to the projected position of a distinct medial ruga point. These measurements will be made with sliding calipers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Div 1 Malocclusion, Protrusion, Incisor
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flapless corticotomy
Arm Type
Experimental
Arm Description
Flapless corticotomy will be conducted in this group of patients.
Arm Title
Traditional corticotomy
Arm Type
Active Comparator
Arm Description
Traditional corticotomy will be performed in this group.
Intervention Type
Procedure
Intervention Name(s)
Flapless corticotomy surgical intervention will be conducted
Intervention Description
Piezocision will be used to perform the procedure
Intervention Type
Procedure
Intervention Name(s)
Traditional corticotomy
Intervention Description
Here the surgery involves elevation of flaps and then conducting the surgical intervention using piezo-surgery cutting saws.
Primary Outcome Measure Information:
Title
Duration of en-masse retraction of anterior teeth
Description
Assessment will be performed by calculating the months required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
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.
Title
Rate of retraction
Description
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.
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.
Title
Change in Incisors' positions
Description
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.
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)
Title
Change in Molars' positions
Description
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.
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)
Title
Change in the SNA angle
Description
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.
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.
Title
Change in the SNB angle
Description
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.
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.
Title
Change in the ANB angle
Description
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.
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.
Title
Change in the SN.GoMe angle
Description
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.
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.
Title
Change in the MM angle
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in the levels of pain and discomfort
Description
Assessment will be performed using questionnaires via visual analog scales (VAS)
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
Title
Change in the Plaque index
Description
The plaque index will be used to assess the status of the oral hygiene in these patients.
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.
Title
Change in the Gingival index
Description
The Gingival index will be used to assess the status of the gingival tissues around the teeth.
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.
Title
Change in the Bleeding index
Description
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.
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.
Title
Gingival Recession
Description
This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.
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.
Title
Change in Tooth Vitality
Description
Tooth vitality will be evaluated for each tooth of the six anterior teeth using Ethyl Chloride applied by a cotton roll.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanin Nizar Khlef, DDS
Organizational Affiliation
MSc student, Department of Orthodontics, University of Damascus Dental School, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc Phd
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Omar Hashmeh, DDS MSc PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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derived

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

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