Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates

Sponsor
Hama University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05950581
Collaborator
(none)
32
1
2
7.1
4.5

Study Details

Study Description

Brief Summary

Patients with skeletal class II malocclusion who have a retracted lower jaw will be treated in this study. The efficacy of clear Plates in the treatment of Skeletal Class II Malocclusion will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.

Condition or Disease Intervention/Treatment Phase
  • Device: Modified Twin-Block Appliance with Clear Plates.
  • Device: Traditional Twin-Block appliance
N/A

Detailed Description

There are two group:
  1. a group of patients in which participants will be undergo to Modified Twin-Block Appliance with Clear Plates.

  2. a group of patients in which participants will be undergo to the traditional Twin-Block Appliance.

phase Intervention/treatment Condition or disease

Not applicable Other:

Modified Twin-Block Appliance with Clear Plates.

Other:

Traditional Twin-Block Appliance. Skeletal class II Malocclusion

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Treatment Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates VS Traditional Twin Block
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: : Modified Twin-Block Appliance with Clear Plates.

Clear plates technique A group of patients in which participants will be undergo to clear plates treatment will be applied to the upper and lower arch 17 hours daily Experimental : Modified Twin-Block Appliance with Clear Plates.

Device: Modified Twin-Block Appliance with Clear Plates.
Clear plates technique A group of patients in which participants will be undergo to clear plates treatment will be applied to the upper and lower arch 17 hours daily

Experimental: Traditional Twin-Block appliance

Traditional Twin-Block appliance A group of patients in which participants will undergo to the Traditional Twin-Block appliance Treatment, appliances will be applied to the upper and lower arch 17 hours daily

Device: Traditional Twin-Block appliance
Traditional Twin-Block appliance A group of patients in which participants will undergo to the Traditional Twin-Block appliance Treatment, appliances will be applied to the upper and lower arch 17 hours daily

Outcome Measures

Primary Outcome Measures

  1. Change in the SNA angle[ [: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and 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.

  2. change in the SNB angle [ [: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and 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.

  3. change in the mandibular length [T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)]

    Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.

  4. change in overjet [T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)]

    Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis.

  5. change in the vertical position of incisors [: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 6-9 months in the exp. Group and control group)]

    The vertical distance from the edge of the lower incisor to the mandibular plane.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    • Patients with mixed dentition at age 10.5-13 years.
  • The patient has Skeletal class II malocclusion caused by mandibular retraction ANB > 5, 8 mm >O.J> 5 mm, SNB<78, angle (NSAr) ≥ ° 125 and normal placement of the upper jaw.

  • The patient is willing to accept treatment with a removable device.

  • No previous orthodontic treatment

  • the growth model is within the normal or horizontal maxillary opening angle of 30 >MM or angle of 400 > Björk

  • patients do not have an upper alveolar dental protrusion.

Exclusion Criteria:
  • -Patients with periodontal disease.

  • patients with a neuromuscular disorder.

  • patients of class I or III of malocclusion.

  • Patients with temporomandibular joint disorder.

  • Patients with Skeletal open bite.

  • Patients with poor oral and gingival health

  • the presence of a unilateral or bilateral posterior crossbite.

  • patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment.

  • any patient who does not meet one or more of the Inclusion criteria will be removed from the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hama University Hama Syrian Arab Republic

Sponsors and Collaborators

  • Hama University

Investigators

  • Study Director: Rabab Alsabbagh,, DDS MSc PhD, Professor of Orthodontics, University of Hama Dental School, Hama, Syria.
  • Principal Investigator: ANAS FAKHOURI, Student in Orthodontics, University of Hama Dental School, Hama.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hama University
ClinicalTrials.gov Identifier:
NCT05950581
Other Study ID Numbers:
  • Hama University -Orthdontic.
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023