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An investigation of treating patients with conventional and skeletal anchored protraction headgear

Treatment outcomes of protraction headgear in pre-pubertal patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12197405
Enrollment
32
Registered
2020-04-07
Start date
2020-01-01
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class III malocclusion Musculoskeletal Diseases

Interventions

Patients will be recruited from the Orthodontic Department in the Department of Dental Surgery at Mater Dei Hospital, Malta. Subsequently, each name will have a correspondent code for the purpose of

Sponsors

University of Malta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Skeletal Class III 2. Healthy children with no systemic diseases 3. Age between 8-12 years 4. Co-operative children 5. Good oral hygiene 6. True skeletal III without shift 7. All dentition present 8. Healthy periodontium 9. No previous orthodontic treatment

Exclusion criteria

Exclusion criteria: 1. Skeletal Class II or I 2. Children with systemic diseases. 3. Below 8 years and above 12 years 4. Apprehensive children 5. Poor oral hygiene 6. Mandibular shift (Pseudo-Class III) 7. Hypodontia 8. Periodontal disease 9. Previous history of orthodontic treatment including removable appliance

Design outcomes

Primary

MeasureTime frame
Compliance rate of wearing protraction headgear assessed using a compliance sensor (Theramon) concealed in the facemask pad over a period of 9 months: T1= 1 month, T2=2 months, T3, T4, T5, T6, T7, T8, and T9.

Secondary

MeasureTime frame
1. Skeletal and dental-related outcome measured with a cephalometric x-ray at T0 before treatment and T1 after treatment 2. Quality of life assessed using the Child Perception Questionnaire (CPQ8-11) before study start T0 (baseline) then on monthly for 9 months (T1 to T9)

Countries

Malta

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026