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NCT Number: NCT06965777

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

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.

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Key information

Age range

3 year–66 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Cairo University

Cairo, 12613, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in D Space (Mandibular Arch)

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

    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

  1. Change in Mandibular Arch Perimeter

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dania Yaser Rahhal Y Rahhal, BDS

CONTACT

[email protected]

+201029020795

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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