Evaluation of Dental and Skeletal Effect of TPA and Nance as a Space Maintainers in Children: A Prospective Clinical Trial

NCT05896618 | Unknown

• 1 other identifier: TPA and Nance space maintainer
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study will aim to evaluate the dental and skeletal effect of the Transpalatal arch and Nance holding arch as a space maintainers in children.

Conditions

Dental Malocclusion

Outcome Measures

Primary Outcomes (1)

• Study cast and cephalometric measurements

  \- Lateral cephalograms measurements: At T1 (before treatment) and at T2 (after 6 month). Lateral cephalograms were traced digitally to measure the angles in degrees \- Dental cast measurements: At T1 and T2. Study casts were made using alginate impressions to evaluate: 1. Arch length in mm. 2. Arch depth in mm 3. Intermolar width in mm 4. Intercanine width in mm

  6 months

Study Arms (2)

Group I

EXPERIMENTAL

TPA group

Device: TPA

Group II

EXPERIMENTAL

Nance group

Device: Nance appliance

Interventions

TPA DEVICE

1\. Group I (TPA group).In which patients will receive Transpalatal arch appliance as a space maintainer. Before treatment, dental cast will be made.Lateral cephalometric radiograph and extra-oral and intra-oral photographs will be taken for each patient. After 6 month follow up period, new cast will be made. New lateral cephalometric radiographs and new extra-oral and intra-oral photographs will be taken for each patient.

Group I

Nance appliance DEVICE

2\. Group II (Nance group).In which patients will receive Nance holding arch appliance as a space maintainer. Before treatment, dental cast will be made.Lateral cephalometric radiograph and extra-oral and intra-oral photographs will be taken for each patient. After 6 month follow up period, new cast will be made. New lateral cephalometric radiographs and new extra-oral and intra-oral photographs will be taken for each patient.

Group II

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age from 6 to 9 years old.
• Skeletal class I or II
• Mixed dentition.
• The permanent incisors and primary canines were present in the maxillary arch.

You may not qualify if:

• Craniofacial anomalies.
• Skeletal posterior crossbite.
• Congenital missing teeth.
• Use of any space maintainer other than Transpalatal arch or Nance holding arch.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Egypt

Cairo, Egypt

Location

Mahmoud Ahmed Abd Elmajeed Omar Hussien

Cairo, Egypt

Location

Related Publications (2)

• Simon T, Nwabueze I, Oueis H, Stenger J. Space maintenance in the primary and mixed dentitions. J Mich Dent Assoc. 2012 Jan;94(1):38-40.

  PMID: 22439522 BACKGROUND

• Raucci G, Pacheco-Pereira C, Grassia V, d'Apuzzo F, Flores-Mir C, Perillo L. Maxillary arch changes with transpalatal arch treatment followed by full fixed appliances. Angle Orthod. 2015 Jul;85(4):683-9. doi: 10.2319/070114-466.1. Epub 2014 Oct 6.

  PMID: 25286341 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Alaa Eldin Ismail

  professor

  STUDY CHAIR

• Ahmed El awady

  lecturer

  STUDY DIRECTOR

• Hamdy Badreldin

  lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 9, 2023
• Study Start: March 5, 2022
• Primary Completion: May 8, 2023
• Study Completion: June 8, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)