The Efficacy of Tow Mechanics for Total-maxillary-arch-distalization

NCT04814173 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with class II division 1 malocclusion who have increased overjet will be treated in this study. The efficacy of one-jaw and tow-jaw mechanics for mini-implants anchored total-maxillary-arch-distalization in the treatment of class II division 1 malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by these tow interventions will be studied. As well as, the pain levels, oral-health related quality of life during all stages of the treatment and the smile components will be explored and compared with the traditional treatment results of this type of malocclusion (en-mass retraction with first premolars extraction). There are three groups :

1. 1.a group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the maxillary arch).
2. 2.a group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (mini-implants in the mandibular arch with class II elastics).
3. 3.a group of patients in which participants will be undergo to the en-mass retraction with first premolars extraction with mini-implants in the maxillary arch.

Conditions

Malocclusion; Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (9)

• Duration of the treatment

  Assessment will be performed by calculating the months required to achieve a normal overjet and canines class I relationships through clinical examination

  duration (in months) between T0: the beginning of active treatment, T1: when a normal overjet and canines class I relationships achieved. (expected to be within 6 months in the exp. groups and 8 months in the control group)

• Change in the Incisors' positions

  Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken when a normal overjet and canines class I relationships will be achieved.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months 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 when a normal overjet and canines class I relationships will be achieved.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group

• Change in the SNA angle

  This angle 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.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups 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.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups 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.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups 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.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups 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.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group

• Change in the nasolabial angle

  This angle the represents the relationship of the upper lip with the nose in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  : T0: 1 day before the beginning of active treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6 months in the exp. groups and 8 months in the control group

Secondary Outcomes (2)

• Change in the levels of spontaneous and chewing pain

  Levels of pain will be assessed at : immediately after the begging of the distalization or retraction (T1), 6 hours (T2) , 24 hours (T3) , 48 hours (T4), 1 week (T5) and 24 hours of each force activation.

• Change in the smile components

  T0: 1 day before the beginning of the treatment . T1: at the end of the treatment (expected to be within 6 months in the exp. groups and 8 months in the control group)

Study Arms (3)

One jaw mechanic

EXPERIMENTAL

Mini-implants anchored total-maxillary-arch-distalization using a one-jaw mechanic (mini-implants in the maxillary arch).

Other: One-jaw mechanic total maxillary arch distalization

Two-jaw mechanic

EXPERIMENTAL

Mini-implants anchored total-maxillary-arch-distalization using a two-jaw mechanic (mini-implants in the mandibular arch with class II elastics).

Other: Two-jaw mechanic total maxillary arch distalization

Traditional treatment

EXPERIMENTAL

traditional en-mass retraction with first premolars extraction with mini-implants in the maxillary arch.

Other: en-mass retraction

Interventions

One-jaw mechanic total maxillary arch distalization OTHER

A group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (the mini-implants will be inserted in the maxillary arch between the roots of 2nd premolar and 1st molar and closer to the molar, then a force of 250 g will be applied from the TAD to a hook lateral to the laterals).

One jaw mechanic

Two-jaw mechanic total maxillary arch distalization OTHER

A group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (the mini-implants will be inserted in the mandibular arch between the 2nd premolar and 1st molar, then, a class II elastics 3/16 and 6.5oz will be use from the TAD to the hook of canines brackets).

Two-jaw mechanic

en-mass retraction OTHER

A group of patients in which participants will be undergo to the en-mass retraction with first premolars extraction with mini-implants in the maxillary arch inserted between the 2nd premolar and 1st molar, then a force of 250 g will be applied from the TAD to a hook lateral to the laterals .

Traditional treatment

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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.
• Patients with class Ⅱ division 1 (ANB angle ≤7 degrees) with severe overjet (5-9 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

• Hama University: lead

Study Sites (1)

Syrian Arab Republic -Department of Orhodontic, University of Hama

Hama, Hama City, Syria

Location

Related Publications (6)

• Choi YJ, Lee JS, Cha JY, Park YC. Total distalization of the maxillary arch in a patient with skeletal Class II malocclusion. Am J Orthod Dentofacial Orthop. 2011 Jun;139(6):823-33. doi: 10.1016/j.ajodo.2009.07.026.

  PMID: 21640890 BACKGROUND

• Bechtold TE, Kim JW, Choi TH, Park YC, Lee KJ. Distalization pattern of the maxillary arch depending on the number of orthodontic miniscrews. Angle Orthod. 2013 Mar;83(2):266-73. doi: 10.2319/032212-123.1. Epub 2012 Sep 12.

  PMID: 22970751 BACKGROUND

• Chen G, Teng F, Xu TM. Distalization of the maxillary and mandibular dentitions with miniscrew anchorage in a patient with moderate Class I bimaxillary dentoalveolar protrusion. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):401-10. doi: 10.1016/j.ajodo.2015.04.041.

  PMID: 26926028 BACKGROUND

• Park CO, Sa'aed NL, Bayome M, Park JH, Kook YA, Park YS, Han SH. Comparison of treatment effects between the modified C-palatal plate and cervical pull headgear for total arch distalization in adults. Korean J Orthod. 2017 Nov;47(6):375-383. doi: 10.4041/kjod.2017.47.6.375. Epub 2017 Sep 29.

  PMID: 29090125 BACKGROUND

• Jo SY, Bayome M, Park J, Lim HJ, Kook YA, Han SH. Comparison of treatment effects between four premolar extraction and total arch distalization using the modified C-palatal plate. Korean J Orthod. 2018 Jul;48(4):224-235. doi: 10.4041/kjod.2018.48.4.224. Epub 2018 Jul 6.

  PMID: 30003056 BACKGROUND

• Shoaib AM, Park JH, Bayome M, Abbas NH, Alfaifi M, Kook YA. Treatment stability after total maxillary arch distalization with modified C-palatal plates in adults. Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):832-839. doi: 10.1016/j.ajodo.2019.01.021.

  PMID: 31784017 BACKGROUND

MeSH Terms

Conditions

Malocclusion; Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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: March 14, 2021
• First Posted: March 24, 2021
• Study Start: May 20, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2021-03

Locations

SY (1)