Glass Fiber-Reinforced Composite Resin Versus Band-and-Loop Space Maintainers in Children: A Split-Mouth Clinical Study

NCT07730944 | Completed

• 1 other identifier: 202603-076-042936-093560
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Loss of Primary Teeth; Space Maintenance; Malocclusion

Keywords

Glass fiber-reinforced composite resin; GFRCR; Premature tooth loss

Outcome Measures

Primary Outcomes (1)

• 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.

  3, 6, and 9 months after appliance placement

Secondary Outcomes (1)

• Gingival health

  3, 6, and 9 months after appliance placement

Study Arms (2)

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.

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.

Device: Conventional Band-and-Loop Space Maintainer

Interventions

Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer DEVICE

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.

Also known as: GFRCR

Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer

Conventional Band-and-Loop Space Maintainer DEVICE

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.

Conventional Band-and-Loop (B&L) Space Maintainer

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ali Assiry: lead

Study Sites (1)

Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University

Najran, Najran Region, 55461, Saudi Arabia

Location

Related Links

• Najran University, Faculty of Dentistry

MeSH Terms

Conditions

Malocclusion; Tooth Loss

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcomes were evaluated by an independent examiner who was unaware of the allocation of the intervention to each quadrant whenever feasible. Due to the nature of the interventions, participants and treating clinicians could not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatric Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: April 25, 2026
• Primary Completion: July 20, 2026
• Study Completion: July 20, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

SA (1)