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Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture

Primary Purpose

Palatal Expansion Technique, Posterior Crossbite, Maxillary Hypoplasia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MARPE with Corticopunctures
MARPE
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, Maxillary Skeletal Expander, Corticopunctures, MARPE

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Suture maturation stage D or E according to the method of Angelieri et al. (Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA, Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013;144(5):759-69.)
  2. Maxillary transverse deficiency measured using the method of Cantarella et al. (Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, et al. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017;18(1):34.)
  3. Good oral hygiene (Score <2 based on the Simplified Oral Hygiene Index (OHI-S)). (Greene JC, Vermillion JR. The Simplified Oral Hygiene Index. J Am Dent Assoc. 1964;68:7-13.)

Exclusion Criteria:

  1. History of previous orthodontic or orthopedic treatment.
  2. History of facial trauma or surgery.
  3. Patients with congenital craniofacial malformations or diagnosed syndromes.
  4. Medical history that prohibits the surgical intervention.

Sites / Locations

  • Faculty of Dentistry, Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Corticopuncture-facilitated MARPE

Conventional MARPE

Arm Description

Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture

Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures.

Outcomes

Primary Outcome Measures

Transverse skeletal changes from baseline to an average of 6 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.

Secondary Outcome Measures

Dento-alveolar inclination changes from baseline to an average of 6 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 dentoalveolar inclination from baseline to the end of passive retention of the expansion.

Full Information

First Posted
September 14, 2022
Last Updated
September 14, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05543460
Brief Title
Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture
Official Title
Assessment of Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture in Adults: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

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
Rapid palatal expansion aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the sutures in adult patients. The study aims to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.
Detailed Description
Rapid palatal expansion is a common treatment modality that aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation and ossification. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the ossified mid-palatal sutures in adult patients. The aim of the study is to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients. A randomized clinical trial will be conducted to address the aim of the study. Patients will be randomly and equally assigned to group 1 (Corticopuncture-facilitated MARPE) or group 2 (Conventional MARPE). Both groups will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea). Ten corticopunctures will be made in group 1 along the mid-palatal suture with the aid of a 3D printed surgical guide. The skeletal and dental changes will be assessed using cone beam computed tomography scans obtained before treatment and after 6 months of expansion stabilization. The results will be compared between the groups and analyzed using the appropriate statistical tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palatal Expansion Technique, Posterior Crossbite, Maxillary Hypoplasia, Malocclusion
Keywords
Rapid palatal expansion, Maxillary Skeletal Expander, Corticopunctures, MARPE

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Corticopuncture-facilitated MARPE
Arm Type
Experimental
Arm Description
Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture
Arm Title
Conventional MARPE
Arm Type
Active Comparator
Arm Description
Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures.
Intervention Type
Procedure
Intervention Name(s)
MARPE with Corticopunctures
Intervention Description
Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency aided with corticopunctures made along the mid-palatal suture
Intervention Type
Device
Intervention Name(s)
MARPE
Intervention Description
Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency
Primary Outcome Measure Information:
Title
Transverse skeletal changes from baseline to an average of 6 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 6 months after the initial activation
Secondary Outcome Measure Information:
Title
Dento-alveolar inclination changes from baseline to an average of 6 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 dentoalveolar inclination from baseline to the end of passive retention of the expansion.
Time Frame
At baseline and an average of 6 months after the initial activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suture maturation stage D or E according to the method of Angelieri et al. (Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA, Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013;144(5):759-69.) Maxillary transverse deficiency measured using the method of Cantarella et al. (Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, et al. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017;18(1):34.) Good oral hygiene (Score <2 based on the Simplified Oral Hygiene Index (OHI-S)). (Greene JC, Vermillion JR. The Simplified Oral Hygiene Index. J Am Dent Assoc. 1964;68:7-13.) Exclusion Criteria: History of previous orthodontic or orthopedic treatment. History of facial trauma or surgery. Patients with congenital craniofacial malformations or diagnosed syndromes. Medical history that prohibits the surgical intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yomna M Yacout, MSC, PhD
Phone
2034868066
Email
yomna.yacout@alexu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmine M Mahmoud, MSc
Phone
2034868066
Email
Jasymme@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna M Yacout, MSc, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eiman S Marzouk, MSc, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yomna M Yacout, MSc, PhD
Phone
2034868066
Email
yomna.yacout@alexu.edu.eg
First Name & Middle Initial & Last Name & Degree
Eiman S Marzouk, MSc, PhD
Phone
2034868066
Email
eiman.marzouk@alexu.edu.eg
First Name & Middle Initial & Last Name & Degree
Yasmine M Mahmoud, MSc
First Name & Middle Initial & Last Name & Degree
Mahmoud A Amin, BDS

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30627452
Citation
Suzuki SS, Braga LFS, Fujii DN, Moon W, Suzuki H. Corticopuncture Facilitated Microimplant-Assisted Rapid Palatal Expansion. Case Rep Dent. 2018 Dec 6;2018:1392895. doi: 10.1155/2018/1392895. eCollection 2018.
Results Reference
background
PubMed Identifier
33802266
Citation
Bud ES, Bica CI, Pacurar M, Vaida P, Vlasa A, Martha K, Bud A. Observational Study Regarding Possible Side Effects of Miniscrew-Assisted Rapid Palatal Expander (MARPE) with or without the Use of Corticopuncture Therapy. Biology (Basel). 2021 Mar 3;10(3):187. doi: 10.3390/biology10030187.
Results Reference
background
PubMed Identifier
24182592
Citation
Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):759-69. doi: 10.1016/j.ajodo.2013.04.022.
Results Reference
background
PubMed Identifier
29090368
Citation
Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, Moon W. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017 Nov 1;18(1):34. doi: 10.1186/s40510-017-0188-7.
Results Reference
background
PubMed Identifier
14076341
Citation
GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
Results Reference
background

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Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture

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