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

NCT ID: NCT06965777

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-03-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Split-mouth Observational Cohort

Children aged 3 to 5.5 years with one mandibular first primary molar extracted due to poor prognosis. The study compares space and arch perimeter changes between the extraction side and the contralateral intact side within the same patient over a 6-month follow-up period using digital 3D models.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 66 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dania Yaser Rahhal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Dania Yaser Rahhal Y Rahhal, BDS

Role: CONTACT

dania.rahhal96@hotmail.com

+201029020795

Other Identifiers

SL&AP-CU

Identifier Type: -

Identifier Source: org_study_id