An observational study in Premature Loss of Primary Molars, Space Maintenance and Dental Arch Development, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 66 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Cairo University · Observational
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.
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.
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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.
Exclusion Criteria:
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.
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
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
Plan to share: No — This study does not plan to share individual participant data (IPD). All data collected will remain confidential and used solely for the purposes of this research. Any results presented will be in aggregate form, without disclosing participant-level data.
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Cairo University