Back to resultsEffect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency
Primary Purpose
Class II Division 1 Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
twin block appliance
modified twin block appliance
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion
Eligibility Criteria
Inclusion Criteria:
- Skeletal Class II relationship (ANB > 4°).
- Mandibular retrognathy (SNB < 78°).
- Overjet ≥ 5 mm.
- Minimal crowding in dental arches (≤4 mm).
- Class II molar relation.
- Growing female patients.
- Patients with CMV3 maturation stage of the cervical verbrae.
Exclusion Criteria:
- No history of orthodontic treatment either prior to or during functional Appliance therapy.
- Posterior cross bites or severe maxillary transverse deficiency.
- Severe facial asymmetry determined by clinical or radiographical examination.
- Poor oral hygiene.
- Systemic diseases that may affect the orthodontic treatment results.
- Patients past their peak growth spurt.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
twin block appliance
modified twin block appliance group
Arm Description
this group will receive conventional twin block appliance and followed up every month for 9 months.
modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months
Outcomes
Primary Outcome Measures
enhancing mandibular skeletal growth
it will be assessed by measuring the incremental growth by quick ceph (mm)
Secondary Outcome Measures
dentoalveolar changes
quick ceph (mm)
Improvement of soft tissue profile
quick ceph (mm)
Patient's compliance
table chart (no of hours/day)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03635463
Brief Title
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency
Official Title
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
double blinded( participant and outcome assessor)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
twin block appliance
Arm Type
Experimental
Arm Description
this group will receive conventional twin block appliance and followed up every month for 9 months.
Arm Title
modified twin block appliance group
Arm Type
Experimental
Arm Description
modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months
Intervention Type
Device
Intervention Name(s)
twin block appliance
Other Intervention Name(s)
mandibular functional appliance
Intervention Description
a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)
Intervention Type
Device
Intervention Name(s)
modified twin block appliance
Intervention Description
a convetional twin block functional appliance that enhances mandibular growth in growing patients
Primary Outcome Measure Information:
Title
enhancing mandibular skeletal growth
Description
it will be assessed by measuring the incremental growth by quick ceph (mm)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
dentoalveolar changes
Description
quick ceph (mm)
Time Frame
9 months
Title
Improvement of soft tissue profile
Description
quick ceph (mm)
Time Frame
9 months
Title
Patient's compliance
Description
table chart (no of hours/day)
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Skeletal Class II relationship (ANB > 4°).
Mandibular retrognathy (SNB < 78°).
Overjet ≥ 5 mm.
Minimal crowding in dental arches (≤4 mm).
Class II molar relation.
Growing female patients.
Patients with CMV3 maturation stage of the cervical verbrae.
Exclusion Criteria:
No history of orthodontic treatment either prior to or during functional Appliance therapy.
Posterior cross bites or severe maxillary transverse deficiency.
Severe facial asymmetry determined by clinical or radiographical examination.
Poor oral hygiene.
Systemic diseases that may affect the orthodontic treatment results.
Patients past their peak growth spurt.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency
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