Pain, Discomfort, and Functional Impairments During Maxillary Expansion

Constriction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248087
• Other study ID #: UDDS-Ortho-02-2022
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: July 25, 2021

Study information

• Verified date: February 2022
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 25, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction
• Constriction, Pathologic

Intervention

Device:
• The bonded McNamara-type appliance
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 removable palatal expansion appliance
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.

Locations

Country	Name	City	State
Syrian Arab Republic	University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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