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NCT Number: NCT04734054

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

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.

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Key information

Conditions

Maxillary Constriction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

About this study

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?.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in the levels of pain and discomfort

    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

    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.

  2. Change in the difficulty in mastication

    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

    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.

  3. Change in the difficulty in swallowing

    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

    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.

  4. Change in the sensation of tension or pressure on soft tissue

    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

    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.

  5. Change in the degree of swelling in soft tissues

    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

    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.

  6. Change in patient's perception of treatment ease

    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

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2021
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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