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

NCT03279042 | Completed DMC

• 1 other identifier: UDDS-Ortho-04-2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

• 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.

  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.

• 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.

  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)

• 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.

  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)

• 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.

  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.

• 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.

  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.

• 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.

  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.

• 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.

  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.

• 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.

  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 Outcomes (6)

• Change in the levels of pain and discomfort

  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

• Change in the Plaque index

  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.

• Change in the Gingival index

  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.

• Change in the Bleeding index

  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.

• Gingival Recession

  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.

Study Arms (2)

Flapless corticotomy

EXPERIMENTAL

Flapless corticotomy will be conducted in this group of patients.

Procedure: Flapless corticotomy surgical intervention will be conducted

Traditional corticotomy

ACTIVE COMPARATOR

Traditional corticotomy will be performed in this group.

Procedure: Traditional corticotomy

Interventions

Flapless corticotomy surgical intervention will be conducted PROCEDURE

Piezocision will be used to perform the procedure

Flapless corticotomy

Traditional corticotomy PROCEDURE

Here the surgery involves elevation of flaps and then conducting the surgical intervention using piezo-surgery cutting saws.

Traditional corticotomy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (9)

• Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.

  PMID: 23787192 BACKGROUND

• Seo KW, Kwon SY, Kim KA, Park KH, Kim SH, Ahn HW, Nelson G. Displacement pattern of the anterior segment using antero-posterior lingual retractor combined with a palatal plate. Korean J Orthod. 2015 Nov;45(6):289-98. doi: 10.4041/kjod.2015.45.6.289. Epub 2015 Nov 20.

  PMID: 26629475 BACKGROUND

• Lee J, Miyazawa K, Tabuchi M, Sato T, Kawaguchi M, Goto S. Effectiveness of en-masse retraction using midpalatal miniscrews and a modified transpalatal arch: Treatment duration and dentoskeletal changes. Korean J Orthod. 2014 Mar;44(2):88-95. doi: 10.4041/kjod.2014.44.2.88. Epub 2014 Mar 19.

  PMID: 24696825 BACKGROUND

• Krishnan P, Shetty S, Husain A. An adjunctive minor surgical procedure for increased rate of retraction. J Pharm Bioallied Sci. 2013 Jun;5(Suppl 1):S39-42. doi: 10.4103/0975-7406.113293.

  PMID: 23946574 BACKGROUND

• Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25.

  PMID: 25309863 BACKGROUND

• Sakthi SV, Vikraman B, Shobana VR, Iyer SK, Krishnaswamy NR. Corticotomy-assisted retraction: an outcome assessment. Indian J Dent Res. 2014 Nov-Dec;25(6):748-54. doi: 10.4103/0970-9290.152191.

  PMID: 25728107 BACKGROUND

• Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.

  PMID: 25478442 BACKGROUND

• Chung KR, Mitsugi M, Lee BS, Kanno T, Lee W, Kim SH. Speedy surgical orthodontic treatment with skeletal anchorage in adults--sagittal correction and open bite correction. J Oral Maxillofac Surg. 2009 Oct;67(10):2130-48. doi: 10.1016/j.joms.2009.07.002.

  PMID: 19761907 BACKGROUND

• Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.

  PMID: 33158633 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II; Overbite

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hanin Nizar Khlef, DDS

  MSc student, Department of Orthodontics, University of Damascus Dental School, Syria

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 12, 2017
• Study Start: September 12, 2016
• Primary Completion: August 12, 2017
• Study Completion: May 15, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)