Pain and Discomfort During Maxillary Expansion
Primary Purpose
Crossbite, Maxillary Hypoplasia
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
orthodontic - maxillary expansion
Sponsored by
About this trial
This is an interventional treatment trial for Crossbite
Eligibility Criteria
Inclusion Criteria:
- Subjects with transversal maxillary deficiency (with or without crossbite).
- Class I or Class II dental malocclusion with uni- or bilateral crossbite and/or constricted maxilla
- Before the pubertal peak (CVM 1-3).
Exclusion Criteria:
- Patients with previous orthodontic treatment
- Hypodontia in any quadrant excluding third molars
- Inadequate oral hygiene
- Craniofacial syndromes, or cleft lip or palate
Sites / Locations
- Università di GenovaRecruiting
- Università di MilanoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
RME (rapid maxillary expander)
Leaf (leaf maxillary expander)
Arm Description
Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with the standard hyrax expansion screw anchored on second deciduous molars
Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with Leaf Expander appliance anchored on second deciduous molars.
Outcomes
Primary Outcome Measures
Crossbite correction
Clinical evaluation in vivo (binary outcome yes/no)
Traversal maxillary deficiency correction
Measured on digital dental casts (increase in mm of the intermolar and intercanine width)
Pain during active expansion phase
Pain reported on Wong-Baker Faces Pain Scale analysis. Pain intensity was assessed using the Wong-Baker scale (Wong and Baker, 1988) from the first to the seventh day of the screw activation, reporting a daily registration in the evening. The Wong-Baker scale is a tool for self-assessment of pain intensity and is used in children from three years of age. The smiles range from the most smiling, corresponding to "no pain", to the one that cries, corresponding to "worst pain imaginable". Each face is also paired with a number, from 0 to 10, which coincides with the intensity of the pain. Higher values represent a worse outcome.
Discomfort during active expansion phase
Discomfort reported on a questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03757468
First Posted
November 12, 2018
Last Updated
June 6, 2019
Sponsor
University of Genova
Collaborators
University of Milan
1. Study Identification
Unique Protocol Identification Number
NCT03757468
Brief Title
Pain and Discomfort During Maxillary Expansion
Official Title
Pain and Discomfort During Maxillary Expansion: A Randomized Multicentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
July 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova
Collaborators
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present study is to investigate and analyze the perception of pain and function impairment during the first week of activation with two different palatal expansion screw to identify an effective pain prevention protocol.
Detailed Description
Maxillary expansion with fixed appliance is a well-known and consolidated practice in clinical orthodontics but current findings of "evidence based dentistry" have not yet identified a better clinical expansion protocol. This issue is due both to the several expansion screws available on the market and to the different screw activation protocols, which could be grouped into rapid and slow, with several customizations. A recent systematic review has shown that both rapid and slow expansion protocols are clinically effective on the primary outcome, i.e. the resolution of the crossbite with a significant increase of skeletal transversal dimension in the maxillary transverse deficiency subjects. If the type of appliance based on its ability to solve the maxillary constriction is not any more the main selection criteria, the choice of the orthodontist should, therefore, be based on the timing and on a "patient-oriented" device, that minimizes the side effects, such as e.g. appliance breakages, functional impairments and pain.
In the orthodontic daily practice, the pain of the little patient is the most frequent symptom during treatment and is the one that most frightens/worries the child and the family. Literature shows that rapid maxillary expansion is, among the early orthodontic therapies, the one with the highest frequency of pain (up to 98%) as an adverse symptom reported by patients. The pain is statistically linked to the rapid expansion protocol (2/turn/day), during which, for each activation of the screw (0.2 or 0.25 mm) the force expressed can reach up to 10 pounds which acts in an orthopaedic manner on the palatine suture and the circummascellar sutures. Following this orthopedic action, a disorganized and highly vascularized connective tissue (inflammatory) is formed in palatine suture area, which becomes the main receptor of the pain perceived by the patient during the active maxillary expansion. In the literature the prevention and management of pain during palate expansion is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice and so the aim of the present study is to investigate and analyze the perception of pain and function impairment during the first week of activation with two different palatal expansion screw to identify an effective pain prevention protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crossbite, Maxillary Hypoplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RME (rapid maxillary expander)
Arm Type
Active Comparator
Arm Description
Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with the standard hyrax expansion screw anchored on second deciduous molars
Arm Title
Leaf (leaf maxillary expander)
Arm Type
Experimental
Arm Description
Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with Leaf Expander appliance anchored on second deciduous molars.
Intervention Type
Device
Intervention Name(s)
orthodontic - maxillary expansion
Other Intervention Name(s)
orthodontic - palatal expansion
Intervention Description
After appliance placement, the screw (hyrax or leaf type) will be activated until overcorrection. Expansion will be considered adequate when the occlusal surface of the first maxillary palatal cusp contact the occlusal surface of the mandibular first molar facial cusp. When will be achieved, the expander will stay in place for 10 months.
Primary Outcome Measure Information:
Title
Crossbite correction
Description
Clinical evaluation in vivo (binary outcome yes/no)
Time Frame
10 months
Title
Traversal maxillary deficiency correction
Description
Measured on digital dental casts (increase in mm of the intermolar and intercanine width)
Time Frame
10 months
Title
Pain during active expansion phase
Description
Pain reported on Wong-Baker Faces Pain Scale analysis. Pain intensity was assessed using the Wong-Baker scale (Wong and Baker, 1988) from the first to the seventh day of the screw activation, reporting a daily registration in the evening. The Wong-Baker scale is a tool for self-assessment of pain intensity and is used in children from three years of age. The smiles range from the most smiling, corresponding to "no pain", to the one that cries, corresponding to "worst pain imaginable". Each face is also paired with a number, from 0 to 10, which coincides with the intensity of the pain. Higher values represent a worse outcome.
Time Frame
1 week
Title
Discomfort during active expansion phase
Description
Discomfort reported on a questionnaire
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with transversal maxillary deficiency (with or without crossbite).
Class I or Class II dental malocclusion with uni- or bilateral crossbite and/or constricted maxilla
Before the pubertal peak (CVM 1-3).
Exclusion Criteria:
Patients with previous orthodontic treatment
Hypodontia in any quadrant excluding third molars
Inadequate oral hygiene
Craniofacial syndromes, or cleft lip or palate
Facility Information:
Facility Name
Università di Genova
City
Genova
State/Province
GE
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Ugolini
Phone
3475971340
Email
alexugolini@yahoo.it
Facility Name
Università di Milano
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianguido Cossellu
Phone
39 02 503 111
Email
gianguido.cossellu@unimi.it
First Name & Middle Initial & Last Name & Degree
Valentina Lanteri
12. IPD Sharing Statement
Plan to Share IPD
No
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Pain and Discomfort During Maxillary Expansion
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