Clinical Evaluation of Bio-creative Therapy for En Masse Retraction of the Maxillary Anterior Teeth

NCT03239275 | Completed DMC

• 1 other identifier: ORD14-1D
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness and efficiency of labial versus lingual biocreative therapy in achieving en masse retraction of the maxillary anterior teeth in subjects with class II malocclusion requiring upper first premolar extraction.

Conditions

Malocclusion, Angle Class II, Division 1

Keywords

en masse retraction; biocreative therapy; class II; skeletal anchorage

Outcome Measures

Primary Outcomes (1)

• Type of anterior tooth movement.

  This would be detected by measurement of the mean change in bucco-lingual inclination of every anterior tooth from the baseline. This outcome will be measured after achieving a normal overjet.

  Expected average of 10 months

Secondary Outcomes (10)

• Change in the nasolabial angle.

  Expected average of 10 months

• Molar anchorage loss

  Expected average of 10 months

• Patient satisfaction from treatment with either the labial or lingual biocreative therapy

  Expected average of 10 months

• Changes in the transverse dimension of the upper arch.

  Expected average of 10 months

• Vertical movement of the crown of the six maxillary anterior teeth

  Expected average of 10 months

Study Arms (2)

Labial biocreative therapy group

EXPERIMENTAL

Upper six anterior teeth will be bonded (0.018-inch slot brackets), leveled and aligned until reaching 0.017\*0.025 stainless steel archwire. Right and left bracket head mini-screw (1.6\*8 mm) will be inserted under local anaesthetic into the inter-radicular space between upper second premolar and first molar at the level of mucogingival junction. Crimpable hooks (10 mm) will be crimped onto the archwire between the upper lateral incisor and canine. 200 grams retraction force will be applied using NiTi coil springs from the hooks to the minscrew on both sides. Overlay reverse curve 0.016\*0.022 NiTi will be inserted posteriorly into the mini-screw and ligated anteriorly to the archwire in the midline.

Procedure: Biocreative therapy

Lingual biocreative therapy group

ACTIVE COMPARATOR

En masse retraction of the six anterior teeth was accomplished using a lingual retractor bonded on to the lingual surface of the 6 anterior teeth, C-palatal plate fixed near the median palatal suture with 3 micro-screws, and Nickel Titanium (Ni-Ti) closing coil springs to apply a force of 200 g per side (total 400 g) directly from the C-plate to the lingual retractor.

Procedure: Biocreative therapy

Interventions

Biocreative therapy PROCEDURE

Labial biocreative therapy group; Lingual biocreative therapy group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Full permanent dentition (excluding third molars)
• Angle class II malocclusion with increased overjet. Treatment plan includes extraction of the upper first premolars and retraction of the maxillary anterior teeth with maximum anchorage.

You may not qualify if:

• Systemic diseases (examples include bleeding disorders, bisphosphonate therapy, chemotherapy, and radiotherapy) or craniofacial anomaly.
• Previous orthodontic treatment.
• Obvious periodontal disease and signs of bone loss.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (11)

• Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.

  PMID: 18617099 BACKGROUND

• Chung KR, Cho JH, Kim SH, Kook YA, Cozzani M. Unusual extraction treatment in Class II division 1 using C-orthodontic mini-implants. Angle Orthod. 2007 Jan;77(1):155-66. doi: 10.2319/020106-35R.1.

  PMID: 17029536 BACKGROUND

• Chung KR, Kim SH, Kook YA, Son JH. Anterior torque control using partial-osseointegrated mini-implants: biocreative therapy type I technique. World J Orthod. 2008 Summer;9(2):95-104.

  PMID: 18575303 BACKGROUND

• Chung KR, Kim SH, Kook YA, Choo H. Anterior torque control using partial-osseointegrated mini-implants: biocreative therapy type II technique. World J Orthod. 2008 Summer;9(2):105-13.

  PMID: 18575304 BACKGROUND

• Su J, Liu J, Zhang D, Luo G, Chen L, Yu X, Lin Z, Zhang J. [Finite-element investigation on center of resistance of maxillary anterior teeth]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2014 Oct;31(5):994-1000. Chinese.

  PMID: 25764710 BACKGROUND

• Miyawaki S, Yasuhara M, Koh Y. Discomfort caused by bonded lingual orthodontic appliances in adult patients as examined by retrospective questionnaire. Am J Orthod Dentofacial Orthop. 1999 Jan;115(1):83-8. doi: 10.1016/s0889-5406(99)70320-3.

  PMID: 9878962 BACKGROUND

• Hong RK, Heo JM, Ha YK. Lever-arm and mini-implant system for anterior torque control during retraction in lingual orthodontic treatment. Angle Orthod. 2005 Jan;75(1):129-41. doi: 10.1043/0003-3219(2005)0752.0.CO;2.

  PMID: 15747828 BACKGROUND

• Park YC, Choi YJ, Choi NC, Lee JS. Esthetic segmental retraction of maxillary anterior teeth with a palatal appliance and orthodontic mini-implants. Am J Orthod Dentofacial Orthop. 2007 Apr;131(4):537-44. doi: 10.1016/j.ajodo.2005.05.051.

  PMID: 17418722 BACKGROUND

• Kim JS, Kim SH, Kook YA, Chung KR, Nelson G. Analysis of lingual en masse retraction combining a C-lingual retractor and a palatal plate. Angle Orthod. 2011 Jul;81(4):662-9. doi: 10.2319/100110-574.1. Epub 2011 Mar 14.

  PMID: 21406002 BACKGROUND

• Kim SH, Hwang YS, Ferreira A, Chung KR. Analysis of temporary skeletal anchorage devices used for en-masse retraction: a preliminary study. Am J Orthod Dentofacial Orthop. 2009 Aug;136(2):268-76. doi: 10.1016/j.ajodo.2007.08.023.

  PMID: 19651358 BACKGROUND

• Sadek MM, Sabet NE, Hassan IT. Type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy in adults: A randomized clinical trial. Korean J Orthod. 2019 Nov;49(6):381-392. doi: 10.4041/kjod.2019.49.6.381. Epub 2019 Nov 26.

  PMID: 31815106 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mais M Sadek, MSc

  Associate lecturerof Orthodontics, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Noha E Sabet, PhD

  Professor and Head of Orthodontic Department, Ain Shams University

  STUDY CHAIR

• Islam T Hassan, PhD

  Professor of Orthodontics, Ain Shams University

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, Department of Orthodontics, Faculty of Dentistry

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 4, 2017
• Study Start: January 17, 2016
• Primary Completion: April 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01