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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-05-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Space Maintenance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel controlled clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nance space maintainer

Conventional space maintainer for the maxillary arch as control

Group Type ACTIVE_COMPARATOR

Nance space maintainer

Intervention Type DEVICE

Conventional space maintainer for the maxillary arch used in mixed dentition

Nance/Transpalatal arch space maintainer

New design of a space maintainer for the maxillary arch

Group Type EXPERIMENTAL

Nance/Transpalatal arch space maintainer

Intervention Type DEVICE

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

Interventions

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Nance/Transpalatal arch space maintainer

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

Intervention Type DEVICE

Nance space maintainer

Conventional space maintainer for the maxillary arch used in mixed dentition

Intervention Type DEVICE

Eligibility Criteria

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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.