Pain and Discomfort During Maxillary Expansion

NCT03757468 | Unknown

• 1 other identifier: RCT_Milano-Genova
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Crossbite; Maxillary Hypoplasia

Outcome Measures

Primary Outcomes (4)

• Crossbite correction

  Clinical evaluation in vivo (binary outcome yes/no)

  10 months

• Traversal maxillary deficiency correction

  Measured on digital dental casts (increase in mm of the intermolar and intercanine width)

  10 months

• 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.

  1 week

• Discomfort during active expansion phase

  Discomfort reported on a questionnaire

  1 week

Study Arms (2)

RME (rapid maxillary expander)

ACTIVE COMPARATOR

Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with the standard hyrax expansion screw anchored on second deciduous molars

Device: orthodontic - maxillary expansion

Leaf (leaf maxillary expander)

EXPERIMENTAL

Intervention orthodontic - maxillary expansion : crossbite or transversal maxillary deficiency correction with Leaf Expander appliance anchored on second deciduous molars.

Device: orthodontic - maxillary expansion

Interventions

orthodontic - maxillary expansion DEVICE

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.

Also known as: orthodontic - palatal expansion

Leaf (leaf maxillary expander); RME (rapid maxillary expander)

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Patients with previous orthodontic treatment
• Hypodontia in any quadrant excluding third molars
• Inadequate oral hygiene
• Craniofacial syndromes, or cleft lip or palate

Sponsors & Collaborators

• University of Genova: lead
• University of Milan: collaborator

Study Sites (2)

Università di Genova

Genova, GE, Italy

RECRUITING

Università di Milano

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Malocclusion; Retrognathia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 29, 2018
• Study Start: September 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)