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Starting soon Not applicable

Banded Helical vs Gerber Space Regainers for Unilateral Space Loss in Children

NCT07853313 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-13

Condition(s) studied

Premature Loss of Primary Second MolarsUnilateral Space Loss

Investigational drug(s) / intervention(s)

Banded Helicle Space RegainerGerber Space Regainer

Banded Helicle Space Regainer: The Banded Helical Space Regainer consists of an orthodontic band cemented on the molar and a helical loop incorporated into the wire design. The appliance is activated to deliver force for space regaining.

Gerber Space Regainer: The Gerber unilateral space regainer consists of a band placed on the permanent molar, a U-shaped wire component, and an open coil spring mechanism that delivers continuous distalizing force.

Study summary

This pilot randomized controlled clinical trial will evaluate and compare Banded Helical and Gerber space regainers in children aged 7-9 years with unilateral space loss following premature loss of a primary second molar. The study will assess the effectiveness of the two appliances in regaining lost space and evaluate treatment duration, patient discomfort, gingival inflammation, plaque accumulation, and appliance failure.

Eligibility

Sex
ALL
Min age
7 Years
Max age
9 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged 7-9 years. * Premature loss of a mandibular primary second molar. * Unilateral space loss in the mandibular arch. * Presence of the required abutment teeth for appliance placement. * Healthy children with no systemic conditions that may affect the study outcomes. Exclusion Criteria: * Bilateral space loss. * Presence of pathological conditions affecting the teeth or supporting tissues. * Previous orthodontic treatment. * Medical conditions or medications that may affect tooth movement or periodontal health. * Poor oral hygiene, if defined according to the study's eligibility criteria.

Primary outcome measure(s)

  • Amount of Space Regained — Baseline (T0) to completion of space regaining, up to 6 months.
    The amount of space regained following application of the space regainer, measured on dental casts using a digital caliper. Measured by mm
  • Rate of Space Regaining — Baseline (T0) to completion of space regaining, up to 6 months.
    The rate of space regaining assessed through serial space measurements during follow-up visits. MEASURING UNIT IS mm/month

Trial sites (1)

FacilityCityRegionStatus
Faculty of dentistry , cairo university Giza Giza Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07853313 on ClinicalTrials.gov ↗ ← All trials in Egypt