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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04562545
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Mandibular Retrognathism; Mandibular Hypoplasia	Device: Modified Twin Block; Device: Twin Block Appliance set to maximum bite	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiorityType: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessor will carry out measurements blindly on pre-operative and post-operative radio-graphs
• Primary Purpose: Treatment
• Official Title: Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials
• Anticipated Study Start Date: Sep 15, 2020
• Anticipated Primary Completion Date: Sep 15, 2021
• Anticipated Study Completion Date: Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Maximum Bite Advancement	Device: Twin Block Appliance set to maximum bite; a traditional twin block set to maximum bite advancement at start of treatment
Experimental: Incremental Bite Advancement	Device: Modified Twin Block; a modified twin block design including jack screws to facilitate incemental advancement

Outcome Measures

Primary Outcome Measures

1. To asses Skeletal and dentoalveolar changes in Mandible [8 Months]

   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)

2. To asses patient compliance [8 months]

   patient will answer a questionnaire at end of treatment

Secondary Outcome Measures

1. To asses Skeletal and dentoalveolar changes in Maxilla [8 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 13 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Khaled Mohamed Ali Hussein, Post Graduate Student, Department of Orthodontics, Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT04562545
• Other Study ID Numbers: CEBD-CU-2020-09-08
• First Posted: Sep 24, 2020
• Last Update Posted: Sep 24, 2020
• Last Verified: Sep 1, 2020

• 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
• Keywords provided by Khaled Mohamed Ali Hussein, Post Graduate Student, Department of Orthodontics, Cairo University, Cairo University: Twin Block; Bite Advancement; Growth Modification
• Additional relevant MeSH terms: Retrognathia; Micrognathism

Study Results

No Results Posted as of Sep 24, 2020