About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in D Space (Mandibular Arch)
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 outcomes
Change in Mandibular Arch Perimeter
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.
Sponsors and contacts
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