Dentoskeletal Changes Produced by Growth Modification Appliances in Treatment of Skeletal Class II Malocclusion

NCT04619446 | Completed DMC

• 1 other identifier: AFIDPakistan
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare dentoskeletal changes in patients with skeletal class II malocclusion induced due to treatment with orthodontic appliances; removable twin block appliance and fixed AdvanSync2 appliance in two different age group patients.

Conditions

Class II Division 1 Malocclusion; Mandibular Retrognathism

Outcome Measures

Primary Outcomes (1)

• effect of Class II malocclusion fixed functional bite corrector in comparison to class II removable bite corrector

  efficacy of both the appliances is to be assessed

  9 to 10 months

Study Arms (2)

Removable Twin Block appliance group

Patient to be treated with removable twin block appliance that are known Class II skeletal and dental subjects.

Device: Removable Twin Block

Fixed Functional Appliance AdvanSync group

Patients to be treated with fixed functional appliance, AdvanSync (Molar-to-Molar) Class II Corrector

Device: Fixed Functional , AdvanSync Appliance

Interventions

Removable Twin Block DEVICE

Twin block appliance (RFA) was introduced by William Clark in 1988. Many modifications for this appliance have been introduced lately. It has been named twin block for the characteristic of two unattached maxillary and mandibular plates with acrylic bite blocks, which makes 70o angle when come in contact with each other. Delta clasps are added for better retention of the appliance. This appliance plays a vital role in the treatment of mandibular retrognathia

Removable Twin Block appliance group

Fixed Functional , AdvanSync Appliance DEVICE

AdvanSync2 (Ormco Co., Glendora, Calif) is a FFA being introduced recently as an advancement of Herbst appliance. It is a molar-to-molar appliance, connected by a telescopic rod, which allow for simultaneous treatment with braces. It is much smaller in size than the conventional Herbst appliance and reduces treatment duration up to six to nine months. It is much more acceptable by the patients as they complain less about sores and discomfort, and is esthetically pleasant since it's not visible in the mouth. Short arms of this appliance help to decrease irritation and discomfort of the patient, and helps to advance the mandible in a constant forward direction to encourage growth, and reduce malocclusion.

Fixed Functional Appliance AdvanSync group

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A.F.I.D, Rawalpindi. Thirty patients ( 15 between cervical vertebral maturation (CVM) stage of 2-3 to be treated with removable functional applianc and remaining 15 between CVM stage of 4-5 to be treated with fixed functional appliance) with skeletal class II malocclusion, presented at the department of Armed forces institute of dentistry (AFID).

You may qualify if:

• Class II div 1 malocclusion with mandible being placed backwards (SNB angle \<78o)
• Convex facial profile
• ANB angle to be \>4 degree
• overall good oral health
• no previous orthodontic treatment being done
• peak of pubertal growth at the start of treatment

You may not qualify if:

• Subjects presenting with any developmental defects
• Asymmetrical facial profile
• Impacted / missing / supernumerary or transposed teeth

Sponsors & Collaborators

• Dr. Fareena Ghaffar: lead

Study Sites (1)

Armed Forces Institute of Dentistry (AFID)

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abdullah Jan, Postgraduate

  Armed Forces institute of Dentistry (AFID)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 6, 2020
• Study Start: September 12, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)