Comparison of Efficacy of Three Orthodontic Appliances

NCT ID: NCT03450551

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-08-31

Brief Summary

To investigate each treatment modality in its "optimal" environment to avoid operator experience bias. Therefore we propose to operate out of three "specialist centres" with specific units providing one modality alone Which of the three orthodontic appliances does achieve best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.

Detailed Description

Patients and materials: The patient population will consist of patients age 10-16 that have, or are close to having, a full permanent dentition, and present to the clinic with Class II malocclusions with more than 1/2 unit II molar relationship. (Normal or deep overbite cases are also included). The treatments to be compared are the three (routinely-used) orthodontic appliances: Twin Block, Herbst and Frog.

Hypothesis: The principal (null) hypothesis is that there is no difference between the three appliances in terms of their effectiveness, efficiency and compliance.

Study design: The study is designed as a multicentre, Prospective Expertise Based Matched Controlled Longitudinal Trial and the assessments will be longitudinal in time.

All patients that consent/assent to be part of the study (and their parents) will receive an information leaflet about the study and will be asked to sign an assent form. Patients are free to discontinue treatment if they wish to do so. The normal length of orthodontic treatment is between 18 and 24 months. Assessments will be taken prior to treatment and throughout the treatment period, with regular progress reviews every 3 months, as per standard practice.

Outcomes: The principal outcome for efficiency is the time taken for completion of treatment. The principal outcomes for effectiveness are the clinical progress, discomfort (caused by the appliance to the patient) and compliance.

Clinical progress will be assessed by measuring tooth movement on each review appointment, using radiographic examination (DPT and lateral cephalograms). Each patient will record discomfort in a visual analogue scale (VAS or Likert scale)and compliance by writing the days the appliance was not in the mouth for any reason.

Covariates: Socio-economic variables: age, gender, etc.

Conditions

Malocclusion, Angle Class II

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Twin Block

61 patients will receive the Twin Block appliance (one of the three appliances being studied)

Group Type: EXPERIMENTAL

Twin Block, Herbst, Frog distalising appliance

Intervention Type: DEVICE

To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.

Herbst

61 patients will receive the Herbst appliance (one of the three appliances being studied)

Group Type: ACTIVE_COMPARATOR

Twin Block, Herbst, Frog distalising appliance

Intervention Type: DEVICE

To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.

Frog distalising appliance

61 patients will receive the Frog distalising appliance (one of the three appliances being studied)

Group Type: ACTIVE_COMPARATOR

Twin Block, Herbst, Frog distalising appliance

Intervention Type: DEVICE

To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.

Interventions

Twin Block, Herbst, Frog distalising appliance

To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients aged 10-16 years of age in the late mixed/permanent dentition with Class II malocclusions (Both Cl II div 1 and Cl II div 2)

2. > 1/2 unit Class II molar relationship bilaterally (at least 3.5mm)

3. Normal or deep overbite cases will be included

4. Skeletal Class II relationship (ANB > 4°)

5. Overjet ≥ 5 mm in Cl II/1 cases

6. Non-extraction cases

Exclusion Criteria

1. Children in the early mixed dentition

2. Class I and Class III malocclusions

3. Malocclusions with less than 1/2 unit II molar relationship

4. Reduced overbite / anterior openbite

5. Medically compromised patients, syndromic patients or patients with severe facial asymmetry

6. Special needs patients not able to comply with instructions / difficulty with compliance

7. Hypodontia or extracted permanent tooth (except third molars)

8. Poor oral hygiene with both Gingival bleeding Index and Plaque Index scoring no more than 1

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Bister, Consultant

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas NHS Trust

Central Contacts

Inas Nasr, Consultant

Role: CONTACT

inasnasr@hotmail.com

+447719595027

Dirk Bister, Consultant

Role: CONTACT

dirk.bister@kcl.ac.uk

02071884415

Other Identifiers

108653

Identifier Type: -

Identifier Source: org_study_id