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

Not Applicable

Completed

• Conditions: Space Maintenance
• Interventions: Device: Nance/Transpalatal arch space maintainer; Device: Nance space maintainer

• Registration Number: NCT05514145
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-20
• Study First Submitted QC: 2022-08-22
• Last Update Submitted: 2022-08-22
• Study First Posted: 2022-08-24
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nance/Transpalatal arch space maintainer	Nance/Transpalatal arch space maintainer	New design of a space maintainer for the maxillary arch
Nance space maintainer	Nance space maintainer	Conventional space maintainer for the maxillary arch as control

Primary Outcome Measures

Name	Time	Method
Efficacy in maintaining arch dimensions	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 Outcome Measures

Name	Time	Method
Patient acceptance by modified faces pain scale	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

Trial Locations

Locations (1)

Faculty of dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt