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

ConditionsPremature Loss of Primary Second MolarsUnilateral Space Loss
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-9
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Banded Helicle Space Regainer

    Device

    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

    Device

    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.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Banded Helical Space RegainerExperimental treatment 1 intervention
Group B: Gerber Space RegainerActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Amount of Space Regained

The amount of space regained following application of the space regainer, measured on dental casts using a digital caliper. Measured by mm

Time frame
Baseline (T0) to completion of space regaining, up to 6 months.
2

Rate of Space Regaining

The rate of space regaining assessed through serial space measurements during follow-up visits. MEASURING UNIT IS mm/month

Time frame
Baseline (T0) to completion of space regaining, up to 6 months.

Secondary outcomes

1

Patient Discomfort

Patient discomfort associated with the use of the space regainer, assessed by clinical evaluation. Binary (Present/Absent) the measuring unit

Time frame
Baseline (T0) to completion of space regaining, up to 6 months
2

Gingival Inflammation Around Appliance

Gingival inflammation around the appliance assessed using a periodontal probe and Gingival Index. Ordinal score (0-3) is the measurment unit

Time frame
Baseline (T0) to completion of space regaining, up to 6 months.
3

Plaque Accumulation

Plaque accumulation around the appliance assessed using a periodontal probe and Plaque Index. Measurement Unit: Ordinal score (0-3)

Time frame
Baseline (T0) to completion of space regaining, up to 6 months.
4

Appliance Breakage/Failure

Occurrence of appliance breakage or failure during the treatment period, assessed by clinical evaluation. Measurement Unit: Binary (Present/Absent)

Time frame
Baseline (T0) to completion of space regaining, up to 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: