Pain, Discomfort, and Functional Impairments During Maxillary Expansion
Primary Purpose
Constriction
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
The bonded McNamara-type appliance
The removable palatal expansion appliance
Sponsored by
About this trial
This is an interventional treatment trial for Constriction focused on measuring Pain, Discomfort, Crossbite, Maxillary expansion
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous orthodontic treatment.
- A severe horizontal growth pattern.
- Any periodontal diseases.
- Any general diseases or syndromes.
Sites / Locations
- University of Damascus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The rapid maxillary expansion
The slow maxillary expansion
Arm Description
The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.
The slow maxillary expansion will be applied using a removable palatal expansion appliance.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05248087
First Posted
February 10, 2022
Last Updated
February 10, 2022
Sponsor
Damascus University
1. Study Identification
Unique Protocol Identification Number
NCT05248087
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
July 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constriction
Keywords
Pain, Discomfort, Crossbite, Maxillary expansion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The rapid maxillary expansion
Arm Type
Experimental
Arm Description
The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.
Arm Title
The slow maxillary expansion
Arm Type
Active Comparator
Arm Description
The slow maxillary expansion will be applied using a removable palatal expansion appliance.
Intervention Type
Device
Intervention Name(s)
The bonded McNamara-type appliance
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
The removable palatal expansion appliance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the levels of discomfort or pain
Description
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.
Time Frame
T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Title
Change in the levels of mastication difficulties
Description
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.
Time Frame
T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Title
Change in the levels of swallowing difficulties
Description
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.
Time Frame
T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Title
Change in the levels of sensation of pressure on soft tissue
Description
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.
Time Frame
T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Previous orthodontic treatment.
A severe horizontal growth pattern.
Any periodontal diseases.
Any general diseases or syndromes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Rabah, DDS,MSc
Organizational Affiliation
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heba M Al-Ibrahim, DDS,MSc
Organizational Affiliation
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rashad M.T. Murad, DDS,MSc,PhD
Organizational Affiliation
Professor of Pharmaceutics, University of Damascus, Faculty of Pharmacology, Damascus, Syria.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23758461
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.
Results Reference
background
PubMed Identifier
23304972
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.
Results Reference
background
PubMed Identifier
28029266
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.
Results Reference
background
PubMed Identifier
31894603
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.
Results Reference
background
PubMed Identifier
20122430
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.
Results Reference
background
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Pain, Discomfort, and Functional Impairments During Maxillary Expansion
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