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Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03635463
Collaborator
(none)
30
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Condition or Disease Intervention/Treatment Phase
  • Device: twin block appliance
  • Device: modified twin block appliance
 N/A

Detailed Description

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
double blinded( participant and outcome assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: twin block appliance

this group will receive conventional twin block appliance and followed up every month for 9 months.

Device: twin block appliance
a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)
Other Names:
  • mandibular functional appliance

    		•
    Experimental: modified twin block appliance group

    modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months

    Device: modified twin block appliance
    a convetional twin block functional appliance that enhances mandibular growth in growing patients

    Outcome Measures

    Primary Outcome Measures

    1. enhancing mandibular skeletal growth [9 months]

      it will be assessed by measuring the incremental growth by quick ceph (mm)

    Secondary Outcome Measures

    1. dentoalveolar changes [9 months]

      quick ceph (mm)

    2. Improvement of soft tissue profile [9 months]

      quick ceph (mm)

    3. Patient's compliance [9 months]

      table chart (no of hours/day)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 12 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Skeletal Class II relationship (ANB > 4°).

    2. Mandibular retrognathy (SNB < 78°).

    3. Overjet ≥ 5 mm.

    4. Minimal crowding in dental arches (≤4 mm).

    5. Class II molar relation.

    6. Growing female patients.

    7. Patients with CMV3 maturation stage of the cervical verbrae.

    Exclusion Criteria:

    1. No history of orthodontic treatment either prior to or during functional Appliance therapy.

    2. Posterior cross bites or severe maxillary transverse deficiency.

    3. Severe facial asymmetry determined by clinical or radiographical examination.

    4. Poor oral hygiene.

    5. Systemic diseases that may affect the orthodontic treatment results.

    6. Patients past their peak growth spurt.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heba Yehia, assistant lecturer, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03635463
    Other Study ID Numbers:
    • CEBD-CU-2018-08-05
    First Posted:
    Aug 17, 2018
    Last Update Posted:
    Dec 3, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Micrognathism
    Malocclusion

    Study Results

    No Results Posted as of Dec 3, 2018