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

NCT06965777 | Not Yet Recruiting

• 1 other identifier: SL&AP-CU
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Loss of Primary Molars; Space Maintenance; Dental Arch Development; Pediatric Tooth Extraction

Keywords

Tooth Loss; Dental Arch; Pediatric Dentistry; Primary Dentition

Outcome Measures

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.

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

Secondary Outcomes (1)

• Change in Mandibular Arch Perimeter

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 3 Years - 66 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Dania Yaser Rahhal Y Rahhal, BDS

CONTACT

+201029020795; dania.rahhal96@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)