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

Alexandria University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Space Maintenance

Interventions

Nance/Transpalatal arch space maintainerDEVICE

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

Nance space maintainerDEVICE

Conventional space maintainer for the maxillary arch used in mixed dentition

Eligibility

Sex: ALLMin age: 8 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Faculty of dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Efficacy in maintaining arch dimensions

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.

Time frame: 9 months

Secondary Outcomes

Patient acceptance by modified faces pain scale

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

Time frame: 9 months

Data from ClinicalTrials.gov

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