Micro-invasive Methods of Mid-palatal Sutural Separation

NCT05740592 | Unknown

• 1 other identifier: 627422
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial aims to evaluate the effect of different micro-invasive methods (piezoelectric and micro-osteoperforation) along with tooth-tooth borne RPE compare to tooth-bone borne MARPE on the amount of mid-palatal sutural separation in late adolescent patients. Null Hypothesis There is no effect of adjunctive micro-invasive methods (piezoelectric and microosteoperforation) on mid-palatal suture separation with tooth-tooth borne RPE appliance compared to tooth-bone borne MARPE

Conditions

Maxillary Expansion

Keywords

microincision; microosteoperforation; MARPE; Hyrax; adolescents

Outcome Measures

Primary Outcomes (6)

• Intraoral scanner outcomes

  the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.

  T0: before expansion

• Intraoral scanner outcomes

  the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.

  T1:3 months after expansion

• Intraoral scanner outcomes

  the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.

  T2: 6 months after expansion

• CBCT Outcomes

  In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars

  T0: before expansion

• CBCT Outcomes

  In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars

  T1:3 months after expansion

• CBCT Outcomes

  In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars

  T2:6 months after expansion.

Secondary Outcomes (10)

• Treatment duration

  T0: before expansion, T4:3 months after expansion, T5:6 months after expansion.

• Treatment duration

  T0: before expansion

• Treatment duration

  T1:3 months after expansion

• Treatment duration

  T2: 3 months after expansion

• Periodontal health

  T0: before expansion

Study Arms (3)

tooth-tooth borne RPE with MOPs

EXPERIMENTAL

many approaches have been established to speed up orthodontic tooth movement and to decrease adverse effects. These methods are classified as, microinvasive methods include cortectomies and distraction osteogenesis and microinvasive methods include micro-osteoperforations (MOPs) and piezocision Microtrauma to the bone showed increase the synthesis of cytokines and chemokines, which are routinely released when orthodontic forces are applied . As a result, the affected area is undergoing a faster bone regeneration process

Procedure: micro-osteoperforations ,microincision

Tooth-Tooth borne RPE with Piezocision group

EXPERIMENTAL

Piezosurgery is an ultrasonic micro vibration-based bone cutting method. It used as a careful, promising, and soft tissue sparing method. In addition to its simplicity of use in the clinic, scientific evidence from animal models measuring wound healing and bone formation suggests that, piezosurgery has a better tissue response than traditional bone-cutting procedures .

Procedure: micro-osteoperforations ,microincision

Tooth-Bone borne RPE group (MARPE)

ACTIVE COMPARATOR

The MARPE is a RPE device with a rigid element that attached to palate by the aid of miniscrew, exerting the expansion force directly to the maxilla's basal bone

Procedure: micro-osteoperforations ,microincision

Interventions

micro-osteoperforations ,microincision PROCEDURE

Patients in MOPs group will be subjected to minimal 6 MOPs 2mm apart and corticoperforation will be conducted by using drilling bure and only 1 or 2mm bicortical in the mid-palatal suture area. Patients with the piezocision group will be subjected to minimal 3 micro incisions spaced 4mm apart and a piezoelectric device with diamond surgical tip (size: 4 mm, thickness: 0.5mm) will be used.. The MARPE technique comprises the insertion of four bicortical miniscrews adjacent to the mid-palatal suture, being two mesial and two distal to the expanding screw. Each MARPE have two arms and will be fixed to molar band by soldering.

Also known as: hyrax

Tooth-Bone borne RPE group (MARPE); Tooth-Tooth borne RPE with Piezocision group; tooth-tooth borne RPE with MOPs

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with the bilateral maxillary transverse deficiency.
• Patient referred by orthodontists for SARME or MARPE.
• Patients with developmental age in stage C or stage D maturation stages .
• Patients without developmental deformity.
• Good oral hygiene.
• Patient with intact maxillary first premolars and first molars.

You may not qualify if:

• Congenital maxillofacial deformities mainly cleft patients.
• Previous orthodontic and surgical treatment on the maxilla.
• Maxillary trauma.
• Previous extraction in the maxillary arch.
• Patients with periodontal disease.

Sponsors & Collaborators

• University of Baghdad: lead

Related Publications (2)

• Altug Atac AT, Karasu HA, Aytac D. Surgically assisted rapid maxillary expansion compared with orthopedic rapid maxillary expansion. Angle Orthod. 2006 May;76(3):353-9. doi: 10.1043/0003-3219(2006)076[0353:SARMEC]2.0.CO;2.

  PMID: 16637711 BACKGROUND

• Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.

  PMID: 12169031 BACKGROUND

MeSH Terms

Interventions

Hyx protein, Drosophila

Study Officials

• Harraa S. Mohammed-Salih, Ph.D.

  University of Baghdad

  STUDY DIRECTOR

Central Study Contacts

Hayder A. Naseri, Ph.D. student

CONTACT

009647726146182; dr.haideraaa@gmail.com

Harraa S. Mohammed-Salih, Ph.D.

CONTACT

009647904546371; dr.harraas.ms@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the nature of the trial, it is impossible to blind the investigator to the group once it is allocated. But the radiologist who uses CBCT will be blinded for the image capturing and thus allow for the blindness of the measurements extracted from the CBCT images that will be made at the soft tissue and skeletal and dental levels.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student

Model Details: The first part of this study will involve a clinical trial to evaluate the efficacy of adjunctive piezoelectric sutural incision and MOPs along with maxillary expansion in terms of dentoalveolar and skeletal transverse induction in late adolescent patients.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: February 23, 2023
• Study Start: March 20, 2023
• Primary Completion: August 20, 2023
• Study Completion: August 20, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share