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

NCT05514145 | Completed

• 1 other identifier: 301015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Space Maintenance

Keywords

Nance/transpalatal arch; Nance space maintainer; Space maintainer; Space maintenance

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• Patient acceptance by modified faces pain scale

  9 months

Study Arms (2)

Nance space maintainer

ACTIVE COMPARATOR

Conventional space maintainer for the maxillary arch as control

Device: Nance space maintainer

Nance/Transpalatal arch space maintainer

EXPERIMENTAL

New design of a space maintainer for the maxillary arch

Device: Nance/Transpalatal arch space maintainer

Interventions

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/Transpalatal arch space maintainer

Nance space maintainer DEVICE

Conventional space maintainer for the maxillary arch used in mixed dentition

Nance space maintainer

Eligibility Criteria

• Age: 8 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student

Model Details: Randomized parallel controlled clinical trial

Study Record Dates

• First Submitted: August 20, 2022
• First Posted: August 24, 2022
• Study Start: January 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)