Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05440526
Other study ID # 586/307
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 10, 2020
Est. completion date April 15, 2022

Study information

Verified date June 2022
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the objective of the current study is to compare the dentofacial effects of the mini-plate anchored Herbst appliance Versus the dentally anchored Twin force bite corrector Appliance in Young Adult Class II Orthodontic Patients with retruded mandible.


Description:

Study design: Prospective randomized clinical study. Study setting and population: This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study. Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion. Intervention: The orthodontic patients involved in this study will be treated by using fixed orthodontic appliances followed by one of two different types of fixed functional appliances; the type IV Herbst appliance (miniplate anchored appliance) and the Twin Force Bite Corrector (dentally anchored appliance). According to the type of the fixed functional appliance the patients will be randomly divided into two groups. The random allocation will be achieved by computer software: - Group I: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the type IV Herbst appliance (mini plate anchored appliance). The age of patients will be (15-20y). - Group II: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the Twin Force Bite Corrector appliance (dentally anchored appliance). The age of patients will be (15-20y). Records: The following diagnostic records will be taken for each patient before and after the fixed functional orthopedic treatment: 1. Standardized study casts. 2. Standardized extra-oral and intra-oral photographs. 3. Lateral cephalometric and panoramic radiographs. Treatment steps: As for Group Ι: 1. Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance. 2. The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured leaving an extended part of the plate in the oral cavity which contain the soldered ball housing. 3. The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint. 4. Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally. 5. When reactivation of the telescopic piston is needed, extension rings are used. As for Group ΙΙ: 1. The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment. 2. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches. 3. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months. 4. Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months. 5. Finally follow finishing steps for each patient. Data management and analysis: The collected data will be tabulated statistically analyzed using Statistical Package for Social Sciences (SPSS, version 18, Inc, and Chicago, Ill).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 15, 2022
Est. primary completion date March 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 20 Years
Eligibility Inclusion Criteria: - Participants will be selected based on the following inclusion criteria: 1. Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB==4°). 2. Mandibular arch with minimum (up to 4mm) or no crowding. 3. All permanent teeth are erupted (3rd molar not included). 4. Good oral and general health. 5. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement. 6. No previous orthodontic treatment. Exclusion Criteria: - 1. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. 2. Patients with untreated decay or any endodontic lesions.

Study Design


Intervention

Procedure:
Herbst Group
Herbst Group: Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance. The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured. The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint.
Device:
TFBC Group
TFBC Group: The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months. Using of class ?? intra-oral elastics for both sides for 2 to 3 months.

Locations

Country Name City State
Egypt Nasr city Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of changes in dentoskeletal cephalometric measurements between Herbst Group and TFBC group lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle. one year and four months
Secondary Amount of changes in dentoskeletal cephalometric measurements within each group separately lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle. one year and four months
See also
  Status Clinical Trial Phase
Completed NCT06024382 - The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients N/A
Recruiting NCT05684510 - Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy N/A
Completed NCT05265416 - Pain and Discomfort in Two Acceleration Methods of Canine Retraction N/A
Completed NCT02000557 - Photographic Analysis of Soft Tissue Facial Profile in Patients With Class II Malocclusion N/A
Completed NCT05592977 - Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars N/A
Completed NCT05227859 - Which is Better Piezosurgery or LLLT in Accelerating Orthodontic Tooth Movement N/A
Completed NCT05555719 - Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study N/A
Active, not recruiting NCT06116500 - Effectiveness of Modified Functional Appliance With Expander N/A
Completed NCT06209086 - Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in Class II Malocclusion N/A
Completed NCT05466344 - the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One Phase 2/Phase 3
Active, not recruiting NCT05166928 - Effect of Upper Third Molar Extraction on Distalization Carriere Motion Appliance :A Prospective Clinical Study N/A
Completed NCT05652244 - Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction N/A
Active, not recruiting NCT06308640 - Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography N/A
Completed NCT05656898 - Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction N/A
Completed NCT05647720 - Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients N/A
Not yet recruiting NCT03863275 - Analysis of Muscle Activity With Myofunctional Devices, Using Surface Electromyography N/A
Completed NCT06209125 - Evaluation of Skeletal and Dental Effect of the New Hybrid Aesthetic Functional Appliance N/A
Completed NCT05418413 - The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion N/A
Recruiting NCT05597748 - Modified Herbst Approach to Improve Chin Projection N/A
Completed NCT05302076 - Clinical Effects of Electrical Stimulation on Speeding up Orthodontic Tooth Movement N/A