Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II

Mandibular Hypoplasia Clinical Trial

Official title:

Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04562545
• Other study ID #: CEBD-CU-2020-09-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: Khaled M. Hussein, B.D.S
• Phone: +201558332038
• Email: Khaled.ali[@]dentistry.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

Description:

• Patients will be clinically and radio-graphically examined for eligibility

• Eligible patients will be randomly assigned to one of two groups:

• Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group

• Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group

• Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.

• Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 13 Years

Eligibility

Inclusion Criteria:

• Growing Female Patient

• Skeletal Class II Malocclusion due to deficient mandible

• Overjet of 7 to 10 mm

• Short or normal vertical facial pattern

• No previous orthodontic nor orthopedic treatment

Exclusion Criteria:

• Syndromes or Chronic Illness

• Skeletal Class II Malocclusion due to excessive maxilla

• Vertical skeletal growth pattern

• Habits

Related Conditions & MeSH terms

• Mandibular Hypoplasia
• Mandibular Retrognathism
• Retrognathia

Intervention

Device:
• Modified Twin Block
a modified twin block design including jack screws to facilitate incemental advancement
• Twin Block Appliance set to maximum bite
a traditional twin block set to maximum bite advancement at start of treatment

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. — View Citation

DeVincenzo JP, Winn MW. Orthopedic and orthodontic effects resulting from the use of a functional appliance with different amounts of protrusive activation. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):181-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses Skeletal and dentoalveolar changes in Mandible	Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in mandible.; - changes that will be assesed include ( mandibular base length / mandibular antero posterior position in relation to cranial base/ Condylar position / lower incisor inclination to mandibular plane)	8 Months
Primary	To asses patient compliance	patient will answer a questionnaire at end of treatment	8 months
Secondary	To asses Skeletal and dentoalveolar changes in Maxilla	Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in maxilla; Changes that will be assesed include ( maxillary base length / maxillary base antero posterior position in relation to cranial base / incisor inclination to palatial plane)	8 months