Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion
Primary Purpose
Maxillary Constriction
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Modified Hyrax Palatal Expander
Removable Palatal Expander
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Constriction focused on measuring posterior crossbite, rapid maxillary expansion, slow maxillary expansion, pain, discomfort
Eligibility Criteria
Inclusion Criteria:
- Patients in the early permanent dentition
- Chronological age between 12 and 16 years
- The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)
- Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically
- Dental and skeletal class I and II malocclusion
- Normal and mild vertical growth pattern
- The presence of upper first premolars and molars
- No general problems
- Good oral health
- No previous orthodontic treatment.
Exclusion Criteria:
- Presence of periodontal diseases
- Presence of general diseases, syndromes or cleft lip and palate
- Patients with previous orthodontic treatment
- Patients with severe horizontal growth pattern
Sites / Locations
- Department of Orthodontics, University of Damascus Dental School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rapid maxillary expansion
Slow maxillary expansion
Arm Description
The rapid maxillary expansion will be conducted using bonded modified Hyrax palatal expander. The expander will be activated twice daily (0.4 mm) until an overcorrection of 2-3 mm will be gained.
The slow maxillary expansion using a removable plate with a midline screw will be accomplished. The expander will be activated twice weekly until an overcorrection of 2-3 mm will be gained.
Outcomes
Primary Outcome Measures
Change in the levels of pain and discomfort
Patients will be asked this question about their feeling of pain and discomfort (Item no 01):
'What is the degree of pain/discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the Visual Analogue Scale (VAS) which is a 10-cm horizontal line with two focal points at its beginning and end (0: there is no pain - 10: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the difficulty in mastication
Patients will be asked this question about any difficulty in mastication (Item no 02):
'Do you have difficulty in mastication?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Change in the difficulty in swallowing
Patients will be asked this question about any difficulty in swallowing (Item no 03):
'Do you have difficulty in swallowing?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Change in the sensation of tension or pressure on soft tissue
Patients will be asked this question about any sense of tension or pressure on soft tissue (Item no 04):
'Do you have a sense of tension or pressure in soft tissue ' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Change in the degree of swelling in soft tissues
Patients will be asked this question about any swelling in soft tissue (Item no 05):
'Do you have swelling in soft tissue?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Change in patient's perception of treatment ease
Patients will be asked this question about the ease of the treatment procedure (Item no 06):
'How easy is the treatment procedure?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (easy), (medium), (hard) or (very hard). The patient will be asked to choose one of the four options.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04734054
Brief Title
Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion
Official Title
Evaluation of Pain, Discomfort, and Functional Impairments During the Orthodontic Treatment of Skeletal Maxillary Constriction Using Rapid Versus Slow Maxillary Expansion in the Early Permeant Dentition: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
September 22, 2019 (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
This study will assess and compare the levels of pain, discomfort, and functional impairments between rapid and slow maxillary expansion in treating skeletal maxillary constriction in the early adolescence period (i.e. between 12 and 16 years).
The study sample will consist of 32 patients who suffer from a skeletal posterior crossbite. The sample will be allocated randomly into two groups: RME group and SME group.
The patients will be asked to fill out the attached questionnaires at three assessment times.
Detailed Description
Skeletal maxillary constriction is a popular orthodontic malocclusion that can be seen at any age. The maxillary expansion is the most important treatment choice of this skeletal problem in the upper jaw. There are many types of maxillary expansion regarding the force amount and the number of expansion times: slow maxillary expansion (SME) rapid maxillary expansion (RME), and semi-rapid maxillary expansion (SRME).
Practitioners are conscious that complaints submitted by children and adolescents during the active phase of expansion, such as pain, discomfort and oral ulcers are common symptoms. This trial of two parallel groups will compare the pain, discomfort and functional impairments accompanying the rapid and slow maxillary expansion in early adolescent patients.
RME group: A bonded modified Hyrax palatal expander will be applied. SME group: A removable palatal expansion appliance with a midline screw will be applied.
To assess the pain, discomfort and functional impairments, patients will be asked to fill out questionnaires of six questions: 1) What is the degree of pain/discomfort you have experienced?; 2) Do you have difficulty in mastication?; 3) Do you have difficulty in swallowing?; 4) Do you have a sense of tension or pressure in soft tissue?; 5) Do you have swelling in soft tissue?; and 6) How easy is the treatment procedure?.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Constriction
Keywords
posterior crossbite, rapid maxillary expansion, slow maxillary expansion, pain, discomfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid maxillary expansion
Arm Type
Experimental
Arm Description
The rapid maxillary expansion will be conducted using bonded modified Hyrax palatal expander. The expander will be activated twice daily (0.4 mm) until an overcorrection of 2-3 mm will be gained.
Arm Title
Slow maxillary expansion
Arm Type
Active Comparator
Arm Description
The slow maxillary expansion using a removable plate with a midline screw will be accomplished. The expander will be activated twice weekly until an overcorrection of 2-3 mm will be gained.
Intervention Type
Device
Intervention Name(s)
Modified Hyrax Palatal Expander
Intervention Description
The rapid maxillary expansion will be performed. The expansion should be accomplished between 10 to 15 days at most. The screw is going to be turned in a rapid manner.
Intervention Type
Device
Intervention Name(s)
Removable Palatal Expander
Intervention Description
The slow maxillary expansion will be performed. The expansion will be performed in a slow manner. Patients may need between 6 to 8 months to achieve the required expansion.
Primary Outcome Measure Information:
Title
Change in the levels of pain and discomfort
Description
Patients will be asked this question about their feeling of pain and discomfort (Item no 01):
'What is the degree of pain/discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the Visual Analogue Scale (VAS) which is a 10-cm horizontal line with two focal points at its beginning and end (0: there is no pain - 10: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Time Frame
T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
Title
Change in the difficulty in mastication
Description
Patients will be asked this question about any difficulty in mastication (Item no 02):
'Do you have difficulty in mastication?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Time Frame
T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
Title
Change in the difficulty in swallowing
Description
Patients will be asked this question about any difficulty in swallowing (Item no 03):
'Do you have difficulty in swallowing?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Time Frame
T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
Title
Change in the sensation of tension or pressure on soft tissue
Description
Patients will be asked this question about any sense of tension or pressure on soft tissue (Item no 04):
'Do you have a sense of tension or pressure in soft tissue ' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Time Frame
T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
Title
Change in the degree of swelling in soft tissues
Description
Patients will be asked this question about any swelling in soft tissue (Item no 05):
'Do you have swelling in soft tissue?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (no), (mild), (moderate) or (severe). The patient will be asked to choose one of the four options.
Time Frame
T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
Title
Change in patient's perception of treatment ease
Description
Patients will be asked this question about the ease of the treatment procedure (Item no 06):
'How easy is the treatment procedure?' A standardized questionnaire will assess pain, discomfort and functional impairments' levels during the active phase of treatment. The 4-point Likert scale will be used consisting of: (easy), (medium), (hard) or (very hard). The patient will be asked to choose one of the four options.
Time Frame
T1: on the 1st day; T2: on the 7th day in the RME group and in the 3rd or 4th month in the SME group; T3: on the 15th day in the RME group and between the 6th and 8th month in the SME group
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:
Patients in the early permanent dentition
Chronological age between 12 and 16 years
The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)
Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically
Dental and skeletal class I and II malocclusion
Normal and mild vertical growth pattern
The presence of upper first premolars and molars
No general problems
Good oral health
No previous orthodontic treatment.
Exclusion Criteria:
Presence of periodontal diseases
Presence of general diseases, syndromes or cleft lip and palate
Patients with previous orthodontic treatment
Patients with severe horizontal growth pattern
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
Organizational Affiliation
MSc student in Orthodontics, University of Damascus, Dental School, Damascus, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22812438
Citation
Martina R, Cioffi I, Farella M, Leone P, Manzo P, Matarese G, Portelli M, Nucera R, Cordasco G. Transverse changes determined by rapid and slow maxillary expansion--a low-dose CT-based randomized controlled trial. Orthod Craniofac Res. 2012 Aug;15(3):159-68. doi: 10.1111/j.1601-6343.2012.01543.x. Epub 2012 Mar 27.
Results Reference
background
PubMed Identifier
22783926
Citation
Gecgelen M, Aksoy A, Kirdemir P, Doguc DK, Cesur G, Koskan O, Ozorak O. Evaluation of stress and pain during rapid maxillary expansion treatments. J Oral Rehabil. 2012 Oct;39(10):767-75. doi: 10.1111/j.1365-2842.2012.02330.x. Epub 2012 Jul 11.
Results Reference
background
PubMed Identifier
30298560
Citation
Cossellu G, Lanteri V, Lione R, Ugolini A, Gaffuri F, Cozza P, Farronato M. Efficacy of ketoprofen lysine salt and paracetamol/acetaminophen to reduce pain during rapid maxillary expansion: A randomized controlled clinical trial. Int J Paediatr Dent. 2019 Jan;29(1):58-65. doi: 10.1111/ipd.12428. Epub 2018 Oct 9.
Results Reference
background
PubMed Identifier
9844209
Citation
Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
Results Reference
background
PubMed Identifier
30991984
Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Results Reference
background
PubMed Identifier
28050498
Citation
Almallah MM, Almahdi WH, Hajeer MY. Evaluation of Low Level Laser Therapy on Pain Perception Following Orthodontic Elastomeric Separation: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):ZC23-ZC28. doi: 10.7860/JCDR/2016/22813.8804. Epub 2016 Nov 1.
Results Reference
background
PubMed Identifier
23075062
Citation
Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18.
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
25757063
Citation
Baldini A, Nota A, Santariello C, Assi V, Ballanti F, Cozza P. Influence of activation protocol on perceived pain during rapid maxillary expansion. Angle Orthod. 2015 Nov;85(6):1015-20. doi: 10.2319/112114-833.1. Epub 2015 Mar 10.
Results Reference
background
PubMed Identifier
27004835
Citation
Bucci R, D'Anto V, Rongo R, Valletta R, Martina R, Michelotti A. Dental and skeletal effects of palatal expansion techniques: a systematic review of the current evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2016 Jul;43(7):543-64. doi: 10.1111/joor.12393. Epub 2016 Mar 23.
Results Reference
result
Learn more about this trial
Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion
We'll reach out to this number within 24 hrs