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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Space Maintenance; Premature Loss of Primary Molars; Dental Arch Development; Pediatric Tooth Extraction

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.

• Study Type: Observational
• Enrollment (Estimated): 11

Contacts and Locations

• Study Contact: Name: Dania Yaser Rahhal Y Rahhal, BDS; Phone Number: +201029020795; Email: dania.rahhal96@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day of Extraction) and 6 Months Post-Extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day of Extraction) and 6 Months Post-Extraction

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 2, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 10, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric Dentistry; Tooth Loss; Primary Dentition; Dental Arch
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: SL&AP-CU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No