None listed
Conditions
Brief summary
This randomized controlled clinical trial was conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University, Syria. The study aims to evaluate whether aesthetic CAD/CAM-fabricated band and loop space maintainers provide better clinical success, gingival health, and parental satisfaction compared with conventional stainless-steel band and loop space maintainers in children. It is hypothesized that CAD/CAM-fabricated space maintainers will demonstrate improved retention, stability, and aesthetic acceptance while maintaining acceptable gingival health. Thirty-six children aged 6–9 years were randomly allocated into three equal groups and followed for up to 12 months.
Interventions
Group 1 (CAD/CAM–PEEK group):
An aesthetic band and loop space maintainer fabricated from polyetheretherketone (PEEK) using computer-aided design and computer-aided manufacturing (CAD/CAM) technology. A digital intraoral scan will be obtained using an intraoral scanner, and the appliance will be digitally designed using CAD software and milled from PEEK discs.
The space maintainer will be cemented using self-adhesive resin cement.
The intervention will be performed as a single clinical procedu
Group 1 (CAD/CAM–PEEK group): An aesthetic band and loop space maintainer fabricated from polyetheretherketone (PEEK) using computer-aided design and computer-aided manufacturing (CAD/CAM) technology. A digital intraoral scan will be obtained using an intraoral scanner, and the appliance will be digitally designed using CAD software and milled from PEEK discs. The space maintainer will be cemented using self-adhesive resin cement. The intervention will be performed as a single clinical procedure with an approximate duration of 45–60 minutes. The mode of administration will be a one-to-one, face-to-face dental clinical procedure conducted in a pediatric dental setting. The intervention will be administered by a qualified pediatric dentist experienced in digital impression techniques and space maintainer placement. Adherence to the intervention will be monitored through scheduled follow-up visits at 1, 3, 6, and 12 months, during which clinical examinations will be conducted and outcomes documented in the patients’ dental records. Group 2 (3D-printed Co-Cr group): An aesthetic band and loop space maintainer fabricated from cobalt–chromium (Co-Cr) alloy using three-dimensional (3D) printing technology and veneered with porcelain. The appliance will be designed digitally, printed, finished, and cemented using self-adhesive resin cement. The intervention will be performed as a single clinical procedure with an approximate duration of 45–60 minutes. The mode of administration will be a one-to-one, face-to-face dental clinical procedure conducted in a pediatric dental setting. The intervention will be administered by a qualified pediatric dentist experienced in space maintainer fabrication and placement. Adherence to the intervention will be monitored through scheduled follow-up visits at 1, 3, 6, and 12 months, during which clinical examinations will be performed and findings recorded in the patients’ dental records.
Sponsors
Faculty of Dentistry, Damascus University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
• Children aged 6 to 9 years old. • At least one prematurely lost primary molar requiring a unilateral fixed space maintainer. • Good general and oral health. • Cooperative behavior suitable for dental treatment (Frankl score 3 or 4). • Parental consent and child assent obtained prior to participation.
Exclusion criteria
• Systemic diseases or syndromes affecting bone or tooth development. • Poor oral hygiene or severe gingivitis. • Uncooperative behavior (Frankl score 1 or 2). • Teeth with extensive caries or pulpal pathology. • Parental refusal to participate in follow-up visits.
Outcome results
None listed