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

NCT04734054 | Completed DMC

• 1 other identifier: UDDS-Ortho-02-2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Constriction

Keywords

posterior crossbite; rapid maxillary expansion; slow maxillary expansion; pain; discomfort

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Rapid maxillary expansion

EXPERIMENTAL

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.

Device: Modified Hyrax Palatal Expander

Slow maxillary expansion

ACTIVE COMPARATOR

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.

Device: Removable Palatal Expander

Interventions

Modified Hyrax Palatal Expander DEVICE

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.

Rapid maxillary expansion

Removable Palatal Expander DEVICE

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.

Slow maxillary expansion

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (10)

• 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.

  PMID: 22812438 BACKGROUND

• 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.

  PMID: 22783926 BACKGROUND

• 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.

  PMID: 30298560 BACKGROUND

• 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.

  PMID: 9844209 BACKGROUND

• 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.

  PMID: 30991984 BACKGROUND

• 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.

  PMID: 28050498 BACKGROUND

• 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.

  PMID: 23075062 BACKGROUND

• 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.

  PMID: 28029266 BACKGROUND

• 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.

  PMID: 25757063 BACKGROUND

• 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.

  PMID: 27004835 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Rabah, DDS,MSc

  Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Heba M Al-Ibrahim, DDS

  MSc student in Orthodontics, University of Damascus, Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS,MSc,PhD

  Associate Professor of Orthodontics, University of Damascus, Dental School, Damascus, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 2, 2021
• Study Start: March 19, 2018
• Primary Completion: June 15, 2019
• Study Completion: September 22, 2019
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)