Clinical trial NCT05248087: Pain, Discomfort, and Functional Impairments During Maxillary Expansion
Official title: Assessment of Patient-centered Outcomes Associated With the Expansion of Skeletally Constricted Upper Jaw in the Adolescents Using Two Types of Expanders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constriction
Keywords: Pain
Discomfort
Crossbite
Maxillary expansion
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Skeletal maxillary constriction is one of the common orthodontic problems of all ages, which could be unilateral or bilateral. If it is neglected and not treated, it may result in later orthodontic problems such as skeletal deviation of the lower jaw. The current study aims to use two types of expanders to treat skeletal maxillary constriction in adolescents aged between 12 and 16 years. The study sample will include 52 patients who will be equally divided into two groups: the slow and the rapid maxillary expansion groups. Patients will be asked to answer a questionnaire within five assessment times during the expansion procedure. The questionnaire will contain four questions: 1) What is the degree of discomfort/pain? 2) What is the degree of mastication difficulties? 3) What is the degree of swallowing difficulties? 4) What is the degree of any sense of pressure in soft tissue?

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Previous orthodontic treatment.
2. A severe horizontal growth pattern.
3. Any periodontal diseases.
4. Any general diseases or syndromes.

Primary outcomes:
measure: Change in the levels of discomfort or pain
timeFrame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
measure: Change in the levels of mastication difficulties
timeFrame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
measure: Change in the levels of swallowing difficulties
timeFrame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
measure: Change in the levels of sensation of pressure on soft tissue
timeFrame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
name: Nancy Rabah, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
name: Heba M Al-Ibrahim, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_CHAIR
affiliation: Professor of Pharmaceutics, University of Damascus, Faculty of Pharmacology, Damascus, Syria.
name: Rashad M.T. Murad, DDS,MSc,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.