Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods

NCT ID: NCT04518865

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-04-01

Brief Summary

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The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.

Detailed Description

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Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance.

Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.

Conditions

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Class II Malocclusion, Division 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pre-pubertal group.

The patients were allocated into the pre-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS II and CVMS III

Group Type EXPERIMENTAL

Herbst appliance

Intervention Type DEVICE

The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.

post-pubertal group

The patients were allocated into the post-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS V and CVMS IV

Group Type EXPERIMENTAL

Herbst appliance

Intervention Type DEVICE

The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.

Interventions

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Herbst appliance

The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Skeletal Class II malocclusion with retrognathic mandible (ANB \>5°, SNB\<76°)
2. Normal growth pattern (SN/MP angle was in 25°- 35° range)
3. Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
4. Minimal or no crowding in the mandibular arch (0-5mm).
5. Average inclination or slight retroclination of the lower incisor.
6. An overjet greater than 5 mm.

Exclusion Criteria

1. Skletal Class I
2. Craniofacial syndrome.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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khaled farouk

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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khaled Farouk, lecturer

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Al-Azhar university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Herbst azhar

Identifier Type: -

Identifier Source: org_study_id

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