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Clinical Trials/NCT07611292
NCT07611292CompletedNot Applicable

Comparative Evaluation of Periodontal Biocompatibility of Pediatric Crowns Using Clinical Parameters and GCF Biomarkers

Recep Tayyip Erdogan University Training and Research Hospital1 site in 1 country21 target enrollmentStarted: June 30, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
21
Locations
1

Study Overview

Brief Summary

Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
6 Years to 9 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Children who were aged between 6 and 9 years
  • Children had a score of 3 or 4 on the Frankl Behavioral Scale
  • Children had an indication for full coronal restoration in the primary second molars in all the three quadrants
  • Presence of extensive or chronic carious lesions involving the pulp with radiographic scores ranging between 2 and 3
  • Presence of localized hypoplastic defects
  • Normal or non-resorbed interproximal bone levels, defined radiographically as a distance of no more than 2 mm between the interdental bone crest and the cementoenamel junction
  • Those where the root resorption level was blunt or the apex was rounded, and those where 1/4 of the root has been resorbed

Exclusion Criteria

  • Children had any systemic disease
  • History of allergy to local anesthetic agents, nickel, or resin-based restorative materials
  • Extremely poor oral hygiene
  • Periodontal disease
  • Malocclusion

Investigators

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sema Aydınoglu

associated professor

Recep Tayyip Erdogan University Training and Research Hospital

Study Sites (1)

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