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Dental MalocclusionNCT05896618

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

A study testing TPA and Nance appliance in people with Dental Malocclusion, run by Al-Azhar University at 2 sites in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Dental Malocclusion
What is being tested?
TPA and Nance appliance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesEgypt
Study dates
5 Mar 2022to 8 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Egypt

    Cairo

  • Mahmoud Ahmed Abd Elmajeed Omar Hussien

    Cairo

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
TPA, Nance appliance
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPADevice

    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.
  • Nance applianceDevice

    1. 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.
Study groups in NCT05896618
Study groupRoleWhat they receive
Group IExperimentalTPA group
Receives: Device: TPA
Group IIExperimentalNance group
Receives: Device: Nance appliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start5 Mar 2022
  3. Primary completion8 May 2023
  4. Study completion8 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05896618
Sponsor's protocol ID
TPA and Nance space maintainer
Status last verified
Jun 2023
First submitted
19 May 2023
Last updated
15 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22439522
  • 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.

    PubMed 25286341

Questions about this trial

What is this clinical trial studying?

A study testing TPA and Nance appliance in people with Dental Malocclusion, run by Al-Azhar University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study cast and cephalometric measurements (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05896618, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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