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

Primary Purpose

Dental Malocclusion

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TPA
Nance appliance
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Malocclusion

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Egypt
  • Mahmoud Ahmed Abd Elmajeed Omar Hussien

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

TPA group

Nance group

Outcomes

Primary Outcome Measures

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: Arch length in mm. Arch depth in mm Intermolar width in mm Intercanine width in mm

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
June 13, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05896618
Brief Title
Evaluation of Dental and Skeletal Effect of TPA and Nance as a Space Maintainers in Children: A Prospective Clinical Trial
Official Title
Evaluation of The Dental and Skeletal Effect of Transpalatal Arch and Nance Holding Arch as a Space Maintainers in Children: A Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2022 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
June 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Primary teeth play a critical role in the growth and development of a child. In addition to their role in esthetics, eating, speech, and to encourage normal function and resultant expected growth, the other main function of a primary tooth is to hold space for the permanent successor until it is ready to erupt. The loss of multiple primary molars in the primary or mixed dentition can lead to many disturbances of the developing dentition and occlusion unless an appliance is constructed to maintain the relationship of the remaining teeth and to guide the eruption of the developing teeth. Space management is an important issue in pediatric dentistry, and many studies have been published about space maintainers related to the early extraction of primary teeth. Several techniques have been used to protect the mesiodistal relationship of the teeth on the central arch. One of the best therapies is space maintainer therapy, because it could maintain those primary molars to be exfoliated naturally. The goals of the space maintainer treatment are to prevent teeth from drifting and reducing the space available for the permanent teeth, or to maintain some spaces within the arch so that alignment becomes possible. With the premature loss of a second primary molar, Nance holding arch or Transpalatal (TPA) appliance can be used on the maxillary arch and the lower lingual holding arch (LLHA) for the mandibular arch. The TPA is constructed from 0.9 or 1.25 mm stainless steel wire and crosses the palate to connect one molar or premolar to a contralateral tooth. This connection can be fixed by welding/soldering or be removable by insertion into a lingual sheath on the molar bands. These molar band sheaths are known as Wilson tubes or Mershon attachments. A modification of the attachment involves bonding the palatal wire directly to the lingual surface of the molars. A modified maxillary lingual arch was described by Nance in 1947 and has since been commonly known as the Nance holding arch. The Nance appliance or Nance palatal arch (NPA) was one of the earliest modifications of the TPA. The palatal wire is welded/soldered to the molar bands and is connected anteriorly by an acrylic button positioned in the highest part of the palatal vault resting on non-compressible mucosa. The button is made of heat-cured, cold-cured or lightcured acrylic. Light-cured composite has also been used. Although the acrylic button can be very effective at resisting mesial drift, it does make it difficult for patients to maintain good oral hygiene due to the accumulation of food particles and plaque under the appliance. There is also the potential for tissue irritation and overgrowth of the tissues around the button.The dimensional changes are an important issue when we are interested in evaluation of Transpalatal arch and Nance holding arch. Dimensional changes include protrusion or intrusion of jaw as skeletal changes and proclination and retroclination of incisors as dental changes and also changes in arch length, arch width, intercanine distance and intermolar changes can be detected. Because of this, many studies have investigated arch dimensional changes in various stages of growth and development, such as arch width and arch dimensions. From the previous information that confirm that many problems may occur due to premature loss of maxillary primary molar without space maintainer appliance. Several studies investigate Transpalatal arch and Nance holding arch appliance, but no study interest to evaluate the dental and skeletal effect of both appliances. In this sense, this study will aim to assess the dental and skeletal effectiveness of Transpalatal arch and Nance holding arch appliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
TPA group
Arm Title
Group II
Arm Type
Experimental
Arm Description
Nance group
Intervention Type
Device
Intervention Name(s)
TPA
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nance appliance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study cast and cephalometric measurements
Description
- 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: Arch length in mm. Arch depth in mm Intermolar width in mm Intercanine width in mm
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Craniofacial anomalies. Skeletal posterior crossbite. Congenital missing teeth. Use of any space maintainer other than Transpalatal arch or Nance holding arch.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Eldin Ismail
Organizational Affiliation
professor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed El awady
Organizational Affiliation
lecturer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hamdy Badreldin
Organizational Affiliation
lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Egypt
City
Cairo
Country
Egypt
Facility Name
Mahmoud Ahmed Abd Elmajeed Omar Hussien
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22439522
Citation
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.
Results Reference
background
PubMed Identifier
25286341
Citation
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.
Results Reference
background

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

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