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

NCT07730944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-28

No results posted yet for this study

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

Interventions

DEVICE

Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer

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.

DEVICE

Conventional Band-and-Loop Space Maintainer

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.

Sponsors & Collaborators

  • Ali Assiry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2026-07-20
Completion
2026-07-20

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730944 on ClinicalTrials.gov