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NCT Number: NCT05514145

The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars

This study will evaluate the effectiveness of N-TPA appliance compared to Nance SM in maintaining the arch dimensions after bilateral premature extraction of primary molars in children.

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Key information

Conditions

Space Maintenance

Age range

8 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Alexandria University

Alexandria, Egypt

About this study

In this randomized controlled clinical trial, 30 healthy children, 8-9 years of age with premature extraction of bilateral maxillary primary molars will be selected. Children will be randomly allocated into two equal groups of 15 children each according to the type of the appliance that will be used. Group I will receive a a Nance SM, and Group II a combined N-TPA appliance . Panoramic X-rays and study casts will be made, and baseline measurements will be recorded including arch circumference, intermolar width and arch depth. The appliances will be fabricated and cemented intra-orally.

The patients will be followed up at 3, 6 and 9 months for re-evaluation of arch circumference, intermolar width, arch depth, and patient acceptance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fully erupted maxillary permanent first molars.
  • Angle's class I occlusion.(31)
  • Adequate space for premolar eruption according to Moyer's arch length analysis.(31)
  • Fair to good oral hygiene according to Silness and Loe plaque index.(32)
  • No history of allergy to polymethyl methacrylate.

Exclusion criteria

  • Children with congenitally absent permanent successors.
  • Children with successors not covered by bone with 2/3 of the root formed.(33)

Treatment and study plan

Nance/Transpalatal arch space maintainer

Device

A combined design of both Nance and Transpalatal arch space maintainers as a space maintainer for the maxillary arch in mixed dentition

Nance space maintainer

Device

Conventional space maintainer for the maxillary arch used in mixed dentition

Primary outcomes

  1. Efficacy in maintaining arch dimensions

    Time frame: 9 months

    All arch dimensions are measured with a 0.5 mm stainless steel wire on the study casts which was then measured with a digital caliper in millimeters (accuracy up to 0.02mm):

    • Changes in arch circumference after insertion of both Nance and Nance/transpalatal arch (N-TPA) appliances after 3, 6- and 9-months follow-up.
    • Changes in intermolar width after insertion of both Nance and Nance/transpalatal arch (N-TPA) appliances after 3, 6- and 9-months follow-up.
    • Changes in arch depth after insertion of both Nance and Nance/transpalatal arch (N-TPA) appliances after 3, 6- and 9-months follow-up.

Secondary outcomes

  1. Patient acceptance by modified faces pain scale

    Time frame: 9 months

    Patient acceptance are measured by the modified faces pain scale of both Nance and N-TPA appliances after 3, 6- and 9-months follow-up.

    Patient acceptance is measured as : (a) Satisfied (b) Indifferent (c) Dissatisfied

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars (Randomized Controlled Clinical Trial)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2022
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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