Clinical trial NCT06965777: Space Changes After Premature Loss of Lower First Primary Molars in Children Using Digital Scanning
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature Loss of Primary Molars
Space Maintenance
Dental Arch Development
Pediatric Tooth Extraction
Keywords: Tooth Loss
Dental Arch
Pediatric Dentistry
Primary Dentition
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 3 to 5.5 years attending the Pediatric Dentistry and Dental Public Health outpatient clinics at the Faculty of Dentistry, Cairo University, who require unilateral extraction of the mandibular first primary molar due to poor prognosis and meet the study's inclusion criteria.

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.

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

Primary outcomes:
measure: Change in D Space (Mandibular Arch)
timeFrame: Baseline (Day of Extraction) and 6 Months Post-Extraction
Secondary outcomes:
measure: Change in Mandibular Arch Perimeter
timeFrame: Baseline (Day of Extraction) and 6 Months Post-Extraction
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References: