Patient-reported outcomes associated with face mask and rapid palatal expansion

Patient-reported outcomes of orthodontic treatment for skeletal Class III malocclusion using face mask with rapid palatal expansion: a prospective clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12453635

Enrollment

Registered

2025-07-01

Start date

2023-05-20

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Skeletal class III malocclusion Oral Health

Interventions

The treatment will begin with the placement of a bonded expander on the upper arch. The patients will be instructed to activate the expander once a day until the desired transverse width is achieved.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Skeletal class III caused by maxillary deficiency with or without mandibular prognathism 2. Patients with normal or horizontal growth patterns 3. Patients in early mixed dentition (7-10 years old)

Exclusion criteria

Exclusion criteria: 1. Patients with syndromes or craniofacial abnormalities 2. Patients with vertical growth patterns 3. Poor oral hygiene 4. Previous orthodontic treatment

Design outcomes

Primary

Measure	Time frame
1. Pain 2. Pressure 3. Difficulty in swallowing 4. Difficulty in speaking 5. Lack of confidence All outcomes were measured using the numeric rating scale (NRS) at 24 hours, 1 week, 2 weeks after activation of RME, and after 1 week, 1 month, 3 months and 6 months after facemask application. Participants were asked to rate their experience for each variable between 0 (least severity) and 10 (maximum severity)	—

Measure

Time frame

1. Pain 2. Pressure 3. Difficulty in swallowing 4. Difficulty in speaking 5. Lack of confidence All outcomes were measured using the numeric rating scale (NRS) at 24 hours, 1 week, 2 weeks after activation of RME, and after 1 week, 1 month, 3 months and 6 months after facemask application. Participants were asked to rate their experience for each variable between 0 (least severity) and 10 (maximum severity)

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Syria

Contacts

Public ContactAhmad Burhan

dr.burhan-a@hotmail.com+963 (0)944302075

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026