Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion

Maxillary Constriction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734054
• Other study ID #: UDDS-Ortho-02-2021
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: September 22, 2019

Study information

• Verified date: January 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 22, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Patients in the early permanent dentition

2. Chronological age between 12 and 16 years

3. The presence of a functional unilateral posterior crossbite (with a functional shift) or bilateral posterior crossbite (without any functional shift)

4. Skeletal bilateral maxillary constriction (symmetric constriction) were assessed clinically then confirmed radiographically

5. Dental and skeletal class I and II malocclusion

6. Normal and mild vertical growth pattern

7. The presence of upper first premolars and molars

8. No general problems

9. Good oral health

10. No previous orthodontic treatment.

Exclusion Criteria:

1. Presence of periodontal diseases

2. Presence of general diseases, syndromes or cleft lip and palate

3. Patients with previous orthodontic treatment

4. Patients with severe horizontal growth pattern

Related Conditions & MeSH terms

• Constriction, Pathologic
• Maxillary Constriction

Intervention

Device:
• Modified Hyrax Palatal Expander
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.
• Removable Palatal Expander
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.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (10)

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. — View 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. — View Citation

Bucci R, D'Antò 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 — View 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. — 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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
Primary	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.	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
Primary	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.	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
Primary	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.	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
Primary	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.	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