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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-66
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

11 Participants
are grouped into 1 trial group
Group A: Split-mouth Observational Cohort

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Day of Extraction) and 6 Months Post-Extraction

Secondary outcomes

1

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.

Time frame
Baseline (Day of Extraction) and 6 Months Post-Extraction

Other outcomes

Sponsors and contacts

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