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

Not yet recruiting

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

• Registration Number: NCT06965777
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-10
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-14
• Study Start: 2025-08-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Children aged 3 to 5.5 years
• Mandibular first primary molar indicated for extraction due to extensive decay or hopeless prognosis
• Contralateral mandibular first primary molar must be intact and free of proximal caries
• No eruption of mandibular permanent first molar at the time of enrollment
• Presence of primary canines and second primary molars
• No space maintainers placed
• Parents/caregivers unable or unwilling to fabricate a space maintainer

Exclusion Criteria

• Bilateral premature loss of mandibular first primary molars
• Contralateral mandibular molar has proximal caries or poor prognosis
• Children with good prognosis first primary molars (i.e., not needing extraction)
• Eruption of the mandibular permanent first molar
• Children who already have space maintainers
• Uncooperative behavior preventing study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in D Space (Mandibular Arch)	Baseline (Day of Extraction) and 6 Months Post-Extraction	The change in D space (distance between the mesial midpoint of the second primary molar and the distal midpoint of the primary canine) on the extraction side of the mandibular arch. Measured in millimeters using 3D digital models.

Secondary Outcome Measures

Name	Time	Method
Change in Mandibular Arch Perimeter	Baseline (Day of Extraction) and 6 Months Post-Extraction	The change in the total arch perimeter of the mandibular arch measured using 3D digital models. The arch perimeter is calculated as the sum of linear segments across reference tooth landmarks. Measured in millimeters.

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt