Premature Loss of Primary Second MolarsBHR-GSRNCT07853313
Banded Helical vs Gerber Space Regainers for Unilateral Space Loss in Children
A study testing Banded Helicle Space Regainer and Gerber Space Regainer in people with Premature Loss of Primary Second Molars and Unilateral Space Loss, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Premature Loss of Primary Second Molars, Unilateral Space Loss
- What is being tested?
- Banded Helicle Space Regainer and Gerber Space Regainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Banded Helical Regainer Versus Gerber's Space Regainer for Management of Unilateral Space Loss in Children: A Pilot Randomized Controlled 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.
Read the detailed description
Premature loss of a primary second molar may result in mesial drifting, tipping, or rotation of the adjacent permanent first molar and subsequent loss of arch space. Active space regainers are used to recover the lost space and help restore the arch length.
In this study, children aged 7-9 years presenting with unilateral space loss of 2-4 mm following premature loss of a primary second molar will be enrolled. Eligible participants will be randomly allocated in a 1:1 ratio to receive either a Banded Helical space regainer or a Gerber unilateral space regainer.
The amount of space regained will be measured on dental casts using a digital caliper, and the rate of space regaining will be assessed through serial measurements during monthly follow-up visits. Secondary outcomes will include patient discomfort, gingival inflammation around the appliance, plaque accumulation, and appliance breakage or failure.
Participants will be assessed at baseline and followed monthly until completion of space regaining, for a maximum of 6 months. The study is designed as a pilot randomized controlled clinical trial and will be conducted in the outpatient clinics of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.
- Being tested
- Banded Helicle Space Regainer, Gerber Space Regainer
- Keywords
- Space Regainer, Banded Helical Space Regainer, Gerber Space Regainer, Pediatric Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banded Helicle Space RegainerDevice
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 RegainerDevice
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 group | Role | What they receive |
|---|---|---|
| Banded Helical Space Regainer | Experimental | Participants 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 Receives: Device: Banded Helicle Space Regainer |
| Gerber Space Regainer | Active comparator | Participants 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. Receives: Device: Gerber Space Regainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline (T0) to completion of space regaining, up to 6 months.
Secondary outcomes (4)
Patient Discomfort
Patient discomfort associated with the use of the space regainer, assessed by clinical evaluation. Binary (Present/Absent) the measuring unit
Measured: Baseline (T0) to completion of space regaining, up to 6 months
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
Measured: Baseline (T0) to completion of space regaining, up to 6 months.
Plaque Accumulation
Plaque accumulation around the appliance assessed using a periodontal probe and Plaque Index. Measurement Unit:
Ordinal score (0-3)
Measured: Baseline (T0) to completion of space regaining, up to 6 months.
Appliance Breakage/Failure
Occurrence of appliance breakage or failure during the treatment period, assessed by clinical evaluation. Measurement Unit:
Binary (Present/Absent)
Measured: Baseline (T0) to completion of space regaining, up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Premature Loss of Primary Second MolarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karmiena Wafeek Guirges, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853313
- Sponsor's protocol ID
- CU-PED-BHR-GSR-2026
- Acronym
- BHR-GSR
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38344379Mallikarjun 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.
PubMed 32440056Khalaf 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.
PubMed 35241896Enteghad 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.
PubMed 35469344SILNESS 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.
PubMed 14158464Wright, G. Z., & Kupietzky, A. (2014). Behavior management in dentistry for children (2nd ed.). Wiley-Blackwell.
Proffit, W. R., Fields, H. W., Larson, B., & Sarver, D. M. (2018). Contemporary orthodontics (6th ed.). Elsevier.
Chalakkal 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.
PubMed 22918103Jeffrey A. Dean, editor. McDonald and Avery's Dentistry for the Child and Adolescent. 11th ed. Elsevier; 2021.
Tunison 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.
PubMed 18767508
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Banded Helical Regainer Versus Gerber's Space Regainer for Management of Unilateral Space Loss in Children: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07853313
- Acronym / sponsor ID
- BHR-GSR / CU-PED-BHR-GSR-2026
- Keywords
- Space Regainer, Banded Helical Space Regainer, Gerber Space Regainer, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Premature loss of a primary second molar may result in mesial drifting, tipping, or rotation of the adjacent permanent first molar and subsequent loss of arch space. Active space regainers are used to recover the lost space and help restore the arch length.
In this study, children aged 7-9 years presenting with unilateral space loss of 2-4 mm following premature loss of a primary second molar will be enrolled. Eligible participants will be randomly allocated in a 1:1 ratio to receive either a Banded Helical space regainer or a Gerber unilateral space regainer.
The amount of space regained will be measured on dental casts using a digital caliper, and the rate of space regaining will be assessed through serial measurements during monthly follow-up visits. Secondary outcomes will include patient discomfort, gingival inflammation around the appliance, plaque accumulation, and appliance breakage or failure.
Participants will be assessed at baseline and followed monthly until completion of space regaining, for a maximum of 6 months. The study is designed as a pilot randomized controlled clinical trial and will be conducted in the outpatient clinics of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Banded Helical Space Regainer | Experimental | Device: Banded Helicle Space RegainerParticipants 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 comparator | Device: Gerber Space RegainerParticipants 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. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banded Helicle Space RegainerThe 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. | Device | Banded Helical Space Regainer |
| Gerber Space RegainerThe 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. | Device | Gerber Space Regainer |
Primary outcome
Amount of Space Regained
Time frame: 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
Time frame: 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
4 secondary outcomes
Patient Discomfort
Time frame: Baseline (T0) to completion of space regaining, up to 6 months
Gingival Inflammation Around Appliance
Time frame: Baseline (T0) to completion of space regaining, up to 6 months.
Plaque Accumulation
Time frame: Baseline (T0) to completion of space regaining, up to 6 months.
Appliance Breakage/Failure
Time frame: Baseline (T0) to completion of space regaining, up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 38344379Tatiya 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.
- Background: PubMed 32440056Mallikarjun 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.
- Background: PubMed 35241896Khalaf 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.
- Background: PubMed 35469344Enteghad 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.
- Background: PubMed 14158464SILNESS 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.
- BackgroundWright, 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.
- Background: PubMed 22918103Chalakkal 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.
- BackgroundJeffrey A. Dean, editor. McDonald and Avery's Dentistry for the Child and Adolescent. 11th ed. Elsevier; 2021.
- Background: PubMed 18767508Tunison 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.
- PubMed - Article RecordLink provided by the sponsor.
- PubMed - Article RecordLink provided by the sponsor.
- PubMed - Article RecordLink provided by the sponsor.
- PubMed - Article RecordLink provided by the sponsor.
- PubMed - Article RecordLink provided by the sponsor.
- PubMed - Article RecordLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Premature Loss of Primary Second Molars
RecruitingObservational study
Clinical Safety Guidelines for Managing Distal Shoe Complications
Premature Loss of Primary Molars, Space Maintainer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banded Helicle Space Regainer and Gerber Space Regainer in people with Premature Loss of Primary Second Molars and Unilateral Space Loss, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karmiena Wafeek Guirges, B.D.S. 2022 (+201206960584, karrmiena.guirges@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Space Regained (time frame: Baseline (T0) to completion of space regaining, up to 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07853313, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.