Banded Helical vs Gerber Space Regainers for Unilateral Space Loss in Children
BHR-GSR
Effectiveness of Banded Helical Regainer Versus Gerber's Space Regainer for Management of Unilateral Space Loss in Children: A Pilot Randomized Controlled Trial
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
March 31, 2028
October 1, 2026
September 1, 2026
1.2 years
September 26, 2026
September 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Baseline (T0) to completion of space regaining, up to 6 months.
Rate of Space Regaining
The rate of space regaining assessed through serial space measurements during follow-up visits. MEASURING UNIT IS mm/month
Baseline (T0) to completion of space regaining, up to 6 months.
Secondary Outcomes (4)
Patient Discomfort
Baseline (T0) to completion of space regaining, up to 6 months
Gingival Inflammation Around Appliance
Baseline (T0) to completion of space regaining, up to 6 months.
Plaque Accumulation
Baseline (T0) to completion of space regaining, up to 6 months.
Appliance Breakage/Failure
Baseline (T0) to completion of space regaining, up to 6 months.
Study Arms (2)
Banded Helical Space Regainer
EXPERIMENTALParticipants assigned to this arm will receive a Banded Helical Space Regainer for management of unilateral space loss following premature loss of a primary second molar. The appliance consists of an orthodontic band cemented on the molar and a helical loop incorporated into the wire design, activated to deliver force for space regaining
Gerber Space Regainer
ACTIVE COMPARATORParticipants assigned to this arm will receive a Gerber unilateral space regainer for management of unilateral space loss following premature loss of a primary second molar. The appliance 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \. Children aged between 7 and 9 years old. 2. Unilateral premature loss of primary second molar (E) in either maxilla or mandible.
- Unilateral space loss ranging from 2.0 to 4.0 mm. 4. Sound or restorable adjacent primary first molar (D) or permanent first premolar (4) and fully erupted permanent first molar (6).
- \. Cooperative child and parent showing willingness to comply with follow-up visits.
- \. Medically free children.
You may not qualify if:
- \. Bilateral premature loss of primary second molars requiring bilateral arch appliances.
- Severe dental crowding or underlying skeletal Class II or Class III malocclusion requiring comprehensive orthodontic intervention.
- \. Advanced root resorption or structural breakdown of the anchor tooth. 4. Poor oral hygiene.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry , cairo university
Giza, Giza Governorate, Egypt
Related Publications (10)
Tatiya N, Kesri R, Pattanshetti K, Sankalecha S. Banded Helical Space Regainer-an Innovative Approach for Management of Space Loss: A Case Report. Int J Clin Pediatr Dent. 2023 Nov-Dec;16(6):868-870. doi: 10.5005/jp-journals-10005-2714.
PMID: 38344379BACKGROUNDMallikarjun SB, Wilson B, Joppan S, Puthiyandi S, Suresh M. An Innovative Space Regainer "Banded Helical Retractor" in Space Management: A Case Report. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):467-469. doi: 10.5005/jp-journals-10005-1677.
PMID: 32440056BACKGROUNDKhalaf K, Mustafa A, Wazzan M, Omar M, Estaitia M, El-Kishawi M. Clinical effectiveness of space maintainers and space regainers in the mixed dentition: A systematic review. Saudi Dent J. 2022 Feb;34(2):75-86. doi: 10.1016/j.sdentj.2021.09.025. Epub 2021 Oct 9.
PMID: 35241896BACKGROUNDEnteghad S, Golfeshan F, Sardarian A, Navaei H. A Comparison of Lower Dental Arch Changes Using Two Types of Space Regainers: A Removable Appliance with a Distalizing Screw and a Fixed Double-Banded Appliance. Int J Dent. 2022 Apr 16;2022:4699516. doi: 10.1155/2022/4699516. eCollection 2022.
PMID: 35469344BACKGROUNDSILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PMID: 14158464BACKGROUNDWright, G. Z., & Kupietzky, A. (2014). Behavior management in dentistry for children (2nd ed.). Wiley-Blackwell.
BACKGROUNDProffit, W. R., Fields, H. W., Larson, B., & Sarver, D. M. (2018). Contemporary orthodontics (6th ed.). Elsevier.
BACKGROUNDChalakkal P, Thomas AM, Akkara F, Pavaskar R. New design space regainers: 'lingual arch crossbow' and 'double banded space regainer'. J Indian Soc Pedod Prev Dent. 2012 Apr-Jun;30(2):161-5. doi: 10.4103/0970-4388.100001.
PMID: 22918103BACKGROUNDJeffrey A. Dean, editor. McDonald and Avery's Dentistry for the Child and Adolescent. 11th ed. Elsevier; 2021.
BACKGROUNDTunison W, Flores-Mir C, ElBadrawy H, Nassar U, El-Bialy T. Dental arch space changes following premature loss of primary first molars: a systematic review. Pediatr Dent. 2008 Jul-Aug;30(4):297-302.
PMID: 18767508BACKGROUND
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident in Pediatric Dentistry
Study Record Dates
First Submitted
September 26, 2026
First Posted
October 1, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared publicly because the study involves a limited number of pediatric participants, and sharing individual-level data may raise concerns regarding participant privacy and confidentiality.