Premature Loss of Primary TeethGFRSMNCT07730944
Glass Fiber-Reinforced Composite Resin Versus Band-and-Loop Space Maintainers in Children: A Split-Mouth Clinical Study
A study testing Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer and Conventional Band-and-Loop Space Maintainer in people with Premature Loss of Primary Teeth and Space Maintenance, run by Ali Assiry at 1 site in Saudi Arabia.
Trial summary
This split-mouth randomized clinical study aims to compare the clinical performance of glass fiber-reinforced composite resin (GFRCR) space maintainers with conventional band-and-loop (B\&L) space maintainers following premature loss of primary molars in children. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Premature Loss of Primary Teeth, Space Maintenance, Malocclusion
- What is being tested?
- Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer and Conventional Band-and-Loop Space Maintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Apr 2026to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-8 years. Bilateral premature loss of comparable primary molars indicated for extraction or recently extracted.
- No measurable space loss at the extraction sites. Presence of suitable mesial and distal abutment teeth adjacent to the edentulous space.
- Buccal surfaces of abutment teeth free of dental caries. Class I occlusion or normal primary molar relationship. Presence of succedaneous permanent teeth with no more than one-half of root formation.
- Root resorption of the abutment teeth involving less than one-third of the root length.
- Presence of the bony crypt over the succedaneous tooth germ. Written informed consent obtained from a parent or legal guardian.
Who cannot join
- Existing space loss at the extraction site. Pathological lesions involving the jaws or teeth. Malocclusion or abnormal oral musculature. Systemic diseases or medical conditions affecting dental treatment. Abutment teeth with dental caries or inadequate structure for appliance placement.
- Root resorption of abutment teeth exceeding one-third of the root length. Advanced development or absence of the permanent successor. Inability to attend scheduled follow-up visits or lack of parental consent.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University
Najran, Najran Region, 55461
About this study
Official title: Clinical Performance of Glass Fiber-Reinforced Composite Resin Versus Conventional Band-and-Loop Space Maintainers Following Premature Loss of Primary Molars: A Split-Mouth Comparative Study
This split-mouth randomized clinical study aims to compare the clinical performance of glass fiber-reinforced composite resin (GFRCR) space maintainers with conventional band-and-loop (B\&L) space maintainers following premature loss of primary molars in children. Twenty children aged 5-8 years with bilateral premature loss of comparable primary molars will receive a GFRCR appliance on one side of the dental arch and a conventional B\&L appliance on the contralateral side. Participants will be evaluated at 3, 6, and 9 months for appliance retention, gingival health, dental caries around the abutment teeth, and preservation of the extraction space. The study aims to determine whether GFRCR space maintainers provide clinical performance comparable to conventional B\&L appliances while offering the advantages of improved esthetics and single-visit placement.
Read the detailed description
Premature loss of primary molars may result in undesirable tooth movement, arch length reduction, and subsequent malocclusion. Space maintainers are routinely used to preserve arch integrity until eruption of the permanent successor. The conventional band-and-loop (B\&L) appliance is considered the standard fixed space maintainer; however, it requires laboratory fabrication, multiple clinical visits, and may be associated with cement failure and esthetic limitations.
Glass fiber-reinforced composite resin (GFRCR) space maintainers have emerged as a minimally invasive, esthetic alternative that can be fabricated directly in a single clinical visit without laboratory procedures. Nevertheless, evidence regarding their long-term clinical performance remains limited and inconsistent.
This prospective split-mouth comparative clinical trial will enroll 20 children aged 5-8 years presenting with bilateral premature loss of comparable primary molars at the Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University, Saudi Arabia. Each participant will receive a GFRCR space maintainer in one quadrant (test intervention) and a conventional B\&L appliance in the contralateral quadrant (control intervention), allowing each child to serve as his or her own control and minimizing inter-individual variability.
Before appliance placement, all participants will undergo comprehensive clinical and radiographic examinations, professional oral prophylaxis, and any required restorative treatment. Clinical follow-up examinations will be performed after 3, 6, and 9 months.
The primary outcome is appliance retention (survival).
Secondary outcomes include:
Gingival health around the abutment teeth (Gingival Index). Development of dental caries (International Caries Detection and Assessment System, ICDAS).
Preservation of extraction space measured using a Boley gauge.
Statistical analyses will be performed using paired statistical methods appropriate for the split-mouth design, including the McNemar test for paired categorical outcomes and the Log-rank test for appliance survival analysis. Statistical significance will be established at p < 0.05.
This study will provide clinical evidence regarding the effectiveness of esthetic glass fiber-reinforced composite resin space maintainers compared with the conventional band-and-loop appliance and may support their wider adoption in pediatric dental practice.
- Being tested
- Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer, Conventional Band-and-Loop Space Maintainer
- Keywords
- Glass fiber-reinforced composite resin, GFRCR, Premature tooth loss
- Medical subject headings
- Malocclusion, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass Fiber-Reinforced Composite Resin (GFRCR) Space MaintainerDevice
Also called GFRCR
A directly bonded fixed space maintainer fabricated using Splint-it® glass fiber-reinforced composite resin. The appliance was placed in a single clinical visit to preserve the extraction space following premature loss of a primary molar.
Conventional Band-and-Loop Space MaintainerDevice
A conventionally fabricated stainless-steel band-and-loop fixed space maintainer cemented onto the abutment tooth to preserve the extraction space following premature loss of a primary molar.
| Study group | Role | What they receive |
|---|---|---|
| Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer | Experimental | Participants received a directly bonded glass fiber-reinforced composite resin (GFRCR) space maintainer in one quadrant following premature loss of a primary molar. Each participant also received the comparator intervention in the contralateral quadrant as part of the split-mouth study design. Receives: Device: Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer |
| Conventional Band-and-Loop (B&L) Space Maintainer | Active comparator | Participants received a conventional stainless-steel band-and-loop (B\&L) space maintainer in the contralateral quadrant following premature loss of a primary molar. Each participant also received the experimental intervention in the opposite quadrant. Receives: Device: Conventional Band-and-Loop Space Maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appliance retention (survival rate)
Comparison of the clinical survival and retention of glass fiber-reinforced composite resin (GFRCR) and conventional band-and-loop (B\&L) space maintainers.
Measured: 3, 6, and 9 months after appliance placement
Secondary outcomes (1)
Gingival health
Gingival condition around the abutment teeth assessed using the Löe and Silness Gingival Index.
Measured: 3, 6, and 9 months after appliance placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start25 Apr 2026
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Loss of Primary TeethStudies of the same condition, open and under way.
- 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
- Model description
- This is a randomized split-mouth clinical trial in which each participant receives both interventions. A glass fiber-reinforced composite resin (GFRCR) space maintainer is placed in one quadrant, while a conventional band-and-loop (B\&L) space maintainer is placed in the contralateral quadrant. Each participant serves as his or her own control, minimizing inter-individual variability.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Assiry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Assiry, Najran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730944
- Sponsor's protocol ID
- 202603-076-042936-093560
- Acronym
- GFRSM
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, clinical outcomes, and follow-up data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Glass Fiber-Reinforced Composite Resin Versus Conventional Band-and-Loop Space Maintainers Following Premature Loss of Primary Molars: A Split-Mouth Comparative Study
- ClinicalTrials.gov ID
- NCT07730944
- Acronym / sponsor ID
- GFRSM / 202603-076-042936-093560
- Keywords
- Glass fiber-reinforced composite resin, GFRCR, Premature tooth loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ali AssiryUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 28 Jul 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 split-mouth randomized clinical study aims to compare the clinical performance of glass fiber-reinforced composite resin (GFRCR) space maintainers with conventional band-and-loop (B\&L) space maintainers following premature loss of primary molars in children. Twenty children aged 5-8 years with bilateral premature loss of comparable primary molars will receive a GFRCR appliance on one side of the dental arch and a conventional B\&L appliance on the contralateral side. Participants will be evaluated at 3, 6, and 9 months for appliance retention, gingival health, dental caries around the abutment teeth, and preservation of the extraction space. The study aims to determine whether GFRCR space maintainers provide clinical performance comparable to conventional B\&L appliances while offering the advantages of improved esthetics and single-visit placement.
Detailed description
Premature loss of primary molars may result in undesirable tooth movement, arch length reduction, and subsequent malocclusion. Space maintainers are routinely used to preserve arch integrity until eruption of the permanent successor. The conventional band-and-loop (B\&L) appliance is considered the standard fixed space maintainer; however, it requires laboratory fabrication, multiple clinical visits, and may be associated with cement failure and esthetic limitations.
Glass fiber-reinforced composite resin (GFRCR) space maintainers have emerged as a minimally invasive, esthetic alternative that can be fabricated directly in a single clinical visit without laboratory procedures. Nevertheless, evidence regarding their long-term clinical performance remains limited and inconsistent.
This prospective split-mouth comparative clinical trial will enroll 20 children aged 5-8 years presenting with bilateral premature loss of comparable primary molars at the Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University, Saudi Arabia. Each participant will receive a GFRCR space maintainer in one quadrant (test intervention) and a conventional B\&L appliance in the contralateral quadrant (control intervention), allowing each child to serve as his or her own control and minimizing inter-individual variability.
Before appliance placement, all participants will undergo comprehensive clinical and radiographic examinations, professional oral prophylaxis, and any required restorative treatment. Clinical follow-up examinations will be performed after 3, 6, and 9 months.
The primary outcome is appliance retention (survival).
Secondary outcomes include:
Gingival health around the abutment teeth (Gingival Index). Development of dental caries (International Caries Detection and Assessment System, ICDAS).
Preservation of extraction space measured using a Boley gauge.
Statistical analyses will be performed using paired statistical methods appropriate for the split-mouth design, including the McNemar test for paired categorical outcomes and the Log-rank test for appliance survival analysis. Statistical significance will be established at p < 0.05.
This study will provide clinical evidence regarding the effectiveness of esthetic glass fiber-reinforced composite resin space maintainers compared with the conventional band-and-loop appliance and may support their wider adoption in pediatric dental practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized split-mouth clinical trial in which each participant receives both interventions. A glass fiber-reinforced composite resin (GFRCR) space maintainer is placed in one quadrant, while a conventional band-and-loop (B\&L) space maintainer is placed in the contralateral quadrant. Each participant serves as his or her own control, minimizing inter-individual variability.
| Arm | Type | Receives |
|---|---|---|
| Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer | Experimental | Device: Glass Fiber-Reinforced Composite Resin (GFRCR) Space MaintainerParticipants received a directly bonded glass fiber-reinforced composite resin (GFRCR) space maintainer in one quadrant following premature loss of a primary molar. Each participant also received the comparator intervention in the contralateral quadrant as part of the split-mouth study design. |
| Conventional Band-and-Loop (B&L) Space Maintainer | Active comparator | Device: Conventional Band-and-Loop Space MaintainerParticipants received a conventional stainless-steel band-and-loop (B\&L) space maintainer in the contralateral quadrant following premature loss of a primary molar. Each participant also received the experimental intervention in the opposite quadrant. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5-8 years. Bilateral premature loss of comparable primary molars indicated for extraction or recently extracted.
- No measurable space loss at the extraction sites. Presence of suitable mesial and distal abutment teeth adjacent to the edentulous space.
- Buccal surfaces of abutment teeth free of dental caries. Class I occlusion or normal primary molar relationship. Presence of succedaneous permanent teeth with no more than one-half of root formation.
- Root resorption of the abutment teeth involving less than one-third of the root length.
- Presence of the bony crypt over the succedaneous tooth germ. Written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (2 listed)
- Existing space loss at the extraction site. Pathological lesions involving the jaws or teeth. Malocclusion or abnormal oral musculature. Systemic diseases or medical conditions affecting dental treatment. Abutment teeth with dental caries or inadequate structure for appliance placement.
- Root resorption of abutment teeth exceeding one-third of the root length. Advanced development or absence of the permanent successor. Inability to attend scheduled follow-up visits or lack of parental consent.
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 |
|---|---|---|
| Glass Fiber-Reinforced Composite Resin (GFRCR) Space MaintainerAlso: GFRCRA directly bonded fixed space maintainer fabricated using Splint-it® glass fiber-reinforced composite resin. The appliance was placed in a single clinical visit to preserve the extraction space following premature loss of a primary molar. | Device | Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer |
| Conventional Band-and-Loop Space MaintainerA conventionally fabricated stainless-steel band-and-loop fixed space maintainer cemented onto the abutment tooth to preserve the extraction space following premature loss of a primary molar. | Device | Conventional Band-and-Loop (B&L) Space Maintainer |
Primary outcome
Appliance retention (survival rate)
Time frame: 3, 6, and 9 months after appliance placement
Comparison of the clinical survival and retention of glass fiber-reinforced composite resin (GFRCR) and conventional band-and-loop (B\&L) space maintainers.
1 secondary outcome
Gingival health
Time frame: 3, 6, and 9 months after appliance placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Najran University, Faculty of DentistryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, clinical outcomes, and follow-up data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer and Conventional Band-and-Loop Space Maintainer in people with Premature Loss of Primary Teeth and Space Maintenance, run by Ali Assiry at 1 site in Saudi Arabia.
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 2 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: finished, as of the sponsor's last update on 28 Jul 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appliance retention (survival rate) (time frame: 3, 6, and 9 months after appliance placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.