NCT05248087

Brief Summary

Maxillary expansion is associated with varying degrees of pain and functional impairments. The current study aims to compare rapid maxillary expansion using a McNamara-type (bonded) appliance and slow maxillary expansion using a removable palatal expansion appliance concerning patient-centered outcomes. Those outcomes will include pain and discomfort, mastication difficulties, swallowing difficulties, and pressure on the soft tissues.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

February 10, 2022

Last Update Submit

February 10, 2022

Conditions

Constriction

Keywords

PainDiscomfortCrossbiteMaxillary expansion

Outcome Measures

Primary Outcomes (4)

  • Change in the levels of discomfort or pain

    The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01): 'What is the degree of discomfort/pain?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of discomfort/pain.

    T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months

  • Change in the levels of mastication difficulties

    The degree of mastication difficulties that patients feel will be determined using their answers to the following question (question 02): 'What is the degree of mastication difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of mastication difficulties.

    T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months

  • Change in the levels of swallowing difficulties

    The degree of swallowing difficulties that patients feel will be determined using their answers to the following question (question 03): ' What is the degree of swallowing difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of swallowing difficulties.

    T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months

  • Change in the levels of sensation of pressure on soft tissue

    The degree of any sense of pressure in soft tissue that patients feel will be determined using their answers to the following question (question 04): ' What is the degree of any sense of pressure in soft tissue? ' The Visual Analogue Scale (VAS) will be adopted to measure the degree of any sense of pressure in soft tissue.

    T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months

Study Arms (2)

The rapid maxillary expansion

EXPERIMENTAL

The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.

Device: The bonded McNamara-type appliance

The slow maxillary expansion

ACTIVE COMPARATOR

The slow maxillary expansion will be applied using a removable palatal expansion appliance.

Device: The removable palatal expansion appliance

Interventions

The bonded McNamara-type applianceDEVICE

The patient will be asked to expand twice a day until obtaining an overcorrection of 2-3 mm. Then the expander will be kept in place for three months as a retention period.

The rapid maxillary expansion
The removable palatal expansion applianceDEVICE

The slow maxillary expansion will be applied using a removable palatal expansion appliance with a midline screw. The patient will be asked to expand twice a week until obtaining an overcorrection of 2-3 mm.

The slow maxillary expansion

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents between 12 and 16 years.
  • Early permanent dentition.
  • Skeletal bilateral maxillary constriction.
  • There is no loss or absence of any permanent teeth except for the third molar.
  • Dental and skeletal class I/II malocclusion.
  • Normal/mild vertical growth pattern.

You may not qualify if:

  • Previous orthodontic treatment.
  • A severe horizontal growth pattern.
  • Any periodontal diseases.
  • Any general diseases or syndromes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

  • Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.

    PMID: 23758461BACKGROUND

  • Halicioglu K, Kiki A, Yavuz I. Subjective symptoms of RME patients treated with three different screw activation protocols: a randomised clinical trial. Aust Orthod J. 2012 Nov;28(2):225-31.

    PMID: 23304972BACKGROUND

  • Feldmann I, Bazargani F. Pain and discomfort during the first week of rapid maxillary expansion (RME) using two different RME appliances: A randomized controlled trial. Angle Orthod. 2017 May;87(3):391-396. doi: 10.2319/091216-686.1. Epub 2016 Dec 28.

    PMID: 28029266BACKGROUND

  • Ugolini A, Cossellu G, Farronato M, Silvestrini-Biavati A, Lanteri V. A multicenter, prospective, randomized trial of pain and discomfort during maxillary expansion: Leaf expander versus hyrax expander. Int J Paediatr Dent. 2020 Jul;30(4):421-428. doi: 10.1111/ipd.12612. Epub 2020 Jan 20.

    PMID: 31894603BACKGROUND

  • De Felippe NL, Da Silveira AC, Viana G, Smith B. Influence of palatal expanders on oral comfort, speech, and mastication. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):48-53. doi: 10.1016/j.ajodo.2008.01.023.

    PMID: 20122430BACKGROUND

MeSH Terms

Conditions

Constriction, PathologicPainMalocclusion

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsTooth DiseasesStomatognathic Diseases

Study Officials

  • Nancy Rabah, DDS,MSc

    Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

    PRINCIPAL INVESTIGATOR

  • Heba M Al-Ibrahim, DDS,MSc

    Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

    PRINCIPAL INVESTIGATOR

  • Mohammad Y Hajeer, DDS,MSc,PhD

    Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

    STUDY CHAIR

  • Rashad M.T. Murad, DDS,MSc,PhD

    Professor of Pharmaceutics, University of Damascus, Faculty of Pharmacology, Damascus, Syria.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 21, 2022

Study Start

February 20, 2020

Primary Completion

March 20, 2021

Study Completion

July 25, 2021

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)