search
Back to results

Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents

Primary Purpose

Palatal Expansion Technique, Malocclusion, Posterior Crossbite

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Miniscrew-Supported Maxillary Expander- Slow activation
Miniscrew-Supported Maxillary Expander- Rapid activation
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palatal Expansion Technique focused on measuring Rapid Palatal Expansion, Slow Palatal Expansion, Miniscrew, Bone-borne Expander

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Permanent dentition.
  • Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
  • Good oral hygiene

Exclusion Criteria:

  • History of previous orthodontic or orthopedic treatment
  • History of maxillary trauma
  • Patients with congenital craniofacial malformations
  • Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Slow maxillary expansion

Rapid maxillary expansion

Arm Description

The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day.

The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily.

Outcomes

Primary Outcome Measures

Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dento-alveolar inclination from baseline to the end of passive retention of the expansion.

Secondary Outcome Measures

Pain score on Numeric Rating Scale (NRS) at baseline
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Pain score on NRS after the first activation of the maxillary expander
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Pain score on NRS after 1 week of activation of the maxillary expander
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Pain score on NRS after the last activation of the maxillary expander
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.

Full Information

First Posted
January 5, 2020
Last Updated
June 18, 2021
Sponsor
Alexandria University
search

1. Study Identification

Unique Protocol Identification Number
NCT04225637
Brief Title
Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents
Official Title
Comparison Between Two Activation Protocols of Miniscrew-Supported Maxillary Expander in Adolescents: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

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
Miniscrew-supported maxillary expanders provide advantages over conventional tooth-supported expanders. However, there is no consensus in the literature regarding their activation protocol. The purpose of the clinical trial is to evaluate and compare the effects of slow and rapid activation rates of miniscrew-supported expanders on the skeletal changes, dento-alveolar changes and the pain experience.
Detailed Description
Transverse maxillary deficiency is one of the problems that are commonly encountered in the orthodontic practice. Miniscrew-supported maxillary expansion represents a promising modality for the treatment of transverse maxillary deficiency. However, controversies still exist regarding the activation protocol. One of these controversies is whether using a slow activation protocol would be more beneficial to the patients compared to a rapid activation protocol. Another question that consequently ensues is whether such activation protocol would result in less pain compared to the rapid activation protocol. The null hypothesis of the current study is that there is no difference between slow and rapid activation protocols of miniscrew-supported expander.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palatal Expansion Technique, Malocclusion, Posterior Crossbite, Maxillary Hypoplasia
Keywords
Rapid Palatal Expansion, Slow Palatal Expansion, Miniscrew, Bone-borne Expander

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Slow maxillary expansion
Arm Type
Experimental
Arm Description
The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day.
Arm Title
Rapid maxillary expansion
Arm Type
Experimental
Arm Description
The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily.
Intervention Type
Device
Intervention Name(s)
Miniscrew-Supported Maxillary Expander- Slow activation
Intervention Description
A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated slowly by turning the expansion screw once every other day to correct the transverse maxillary deficiency.
Intervention Type
Device
Intervention Name(s)
Miniscrew-Supported Maxillary Expander- Rapid activation
Intervention Description
A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated rapidly by turning the expansion screw twice per day to correct the transverse maxillary deficiency.
Primary Outcome Measure Information:
Title
Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
Description
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
Time Frame
At baseline and an average of 5 months after the initial activation
Title
Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT
Description
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dento-alveolar inclination from baseline to the end of passive retention of the expansion.
Time Frame
At baseline and an average of 5 months after the initial activation
Secondary Outcome Measure Information:
Title
Pain score on Numeric Rating Scale (NRS) at baseline
Description
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Time Frame
Baseline
Title
Pain score on NRS after the first activation of the maxillary expander
Description
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Time Frame
On day 1 after the first activation of the maxillary expander
Title
Pain score on NRS after 1 week of activation of the maxillary expander
Description
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Time Frame
After 1 week of activation of the maxillary expander
Title
Pain score on NRS after the last activation of the maxillary expander
Description
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Time Frame
At the end of active expansion (an estimated average of 2 to 3 weeks in the rapid expansion group, and 7 to 12 weeks in the slow expansion group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Permanent dentition. Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency Good oral hygiene Exclusion Criteria: History of previous orthodontic or orthopedic treatment History of maxillary trauma Patients with congenital craniofacial malformations Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna M Yacout, BDS, MSc
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadia M El Harouni, BDS,MSc,PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Essam M Abdallah, BDS,MSc,PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25490552
Citation
Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
Results Reference
background
PubMed Identifier
25564504
Citation
Yilmaz A, Arman-Ozcirpici A, Erken S, Polat-Ozsoy O. Comparison of short-term effects of mini-implant-supported maxillary expansion appliance with two conventional expansion protocols. Eur J Orthod. 2015 Oct;37(5):556-64. doi: 10.1093/ejo/cju094. Epub 2015 Jan 6.
Results Reference
background
PubMed Identifier
20197161
Citation
Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
Results Reference
background
PubMed Identifier
28486682
Citation
Algharbi M, Bazargani F, Dimberg L. Do different maxillary expansion appliances influence the outcomes of the treatment? Eur J Orthod. 2018 Jan 23;40(1):97-106. doi: 10.1093/ejo/cjx035.
Results Reference
background
PubMed Identifier
27925236
Citation
Carvalho Trojan L, Andres Gonzalez-Torres L, Claudia Moreira Melo A, Barbosa de Las Casas E. Stresses and Strains Analysis Using Different Palatal Expander Appliances in Upper Jaw and Midpalatal Suture. Artif Organs. 2017 Jun;41(6):E41-E51. doi: 10.1111/aor.12817. Epub 2016 Dec 7.
Results Reference
background
Links:
URL
https://ohrp.cit.nih.gov/search/IrbDtl.aspx
Description
Institutional Review Board (IORG0008839/IRB00010556- Faculty of Dentistry - Alexandria University )
URL
http://dent.alexu.edu.eg/index.php/en/
Description
Faculty of Dentistry, Alexandria University

Learn more about this trial

Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents

We'll reach out to this number within 24 hrs