NCT06965777

Space Changes After Premature Loss of Lower First Primary Molars in Children Using Digital Scanning

The Space Changes Following Premature Loss of Lower First Primary Molars in the Primary Dentition Stage Using Digital Scanning A Prospective Split-mouth Clinical Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 11 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 3 Years – 66 Months
• Healthy volunteers: Accepted

Summary

This prospective split-mouth clinical study aims to evaluate space changes in the mandibular dental arch following premature extraction of the lower first primary molar in children aged 3 to 5.5 years. Using digital 3D models, changes in the D space and mandibular arch perimeter will be measured at baseline and 6 months post-extraction. The goal is to determine whether space maintainers are necessary in the primary dentition stage.

Detailed description

Premature loss of primary molars in children is a common result of caries or trauma, potentially affecting future occlusion and alignment. This study investigates the space changes that occur after unilateral premature extraction of the mandibular first primary molar before the eruption of the permanent first molar. Using a split-mouth design, the contralateral non-extracted side serves as the control. Digital impressions will be taken at baseline (day of extraction) and after 6 months. The primary outcome is the change in the D space, and the secondary outcome is the change in the mandibular arch perimeter, both measured using 3D digital software. The study aims to provide evidence for or against the routine use of space maintainers in similar clinical scenarios, potentially reducing unnecessary treatment and improving patient comfort.

Conditions

• Premature Loss of Primary Molars
• Space Maintenance
• Dental Arch Development
• Pediatric Tooth Extraction

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-05-11
• Last updated: 2025-05-14

Locations

1 site across 1 country: Egypt