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the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One

NCT05466344 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-07-21

No results posted yet for this study

Summary

This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint.

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

Conditions

  • Class II Malocclusion

Interventions

DEVICE

Herbst Group

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.

DEVICE

TFBC Group

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.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Mahmoud Fathy, PHD · Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-03-10
Completion
2022-04-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466344 on ClinicalTrials.gov