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RECRUITING Not applicable ClinicalTrials.gov

Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma Pretreatment

Sponsor: University of Ljubljana, Faculty of Medicine • ClinicalTrials.gov ID: NCT07876167

Registry updated: 2026-10-15
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Description

In this randomized, controlled, double-blind clinical trial, we will follow adult participants who receive partial or full dental crowns made of lithium disilicate ceramic (LDC). Before the crowns are permanently attached to teeth, those in the control group will be etched with hydrofluoric acid (HF) according to the standard laboratory protocol, while those in the intervention group will undergo an innovative surface treatment with atmospheric-pressure nonthermal plasma (APP). The goal of this study is to determine whether the innovative APP pretreatment of LDC crowns can result in outcomes comparable to or better than those achieved with the standard HF treatment, including: * oral health-related quality of life as reported by the participants; and * the clinical success and survival of LDC crowns. Participants will be asked to attend scheduled follow-up visits 1 week and 1, 3, 6, and 12 months after the crowns are cemented. At each visit: * a researcher will examine the crowns and surrounding teeth and tissues for any biological or technical complications; and * participants will complete a questionnaire to assess their oral health-related quality of life.

Interventions

  • Hydrofluoric Acid-Etched Lithium Disilicate Ceramic Dental Crowns (Device)
    * Full-coverage single dental crowns or partial-coverage dental crowns, covering the entire occlusal surface (onlays, overlays), * fabricated from lithium disilicate ceramic using computer-assisted milling, * used to restore posterior teeth (premolars and molars) with vital dental pulp, * etched with hydrofluoric acid and silanized before adhesive cementation, as part of the conventional clinical protocol.
  • Atmospheric-Pressure Plasma-Treated Lithium Disilicate Ceramic Dental Crowns (Device)
    * Full-coverage single dental crowns or partial-coverage dental crowns, covering the entire occlusal surface (onlays, overlays), * fabricated from lithium disilicate ceramic using computer-assisted milling, * used to restore posterior teeth (premolars and molars) with vital dental pulp, * treated with atmospheric-pressure gaseous plasma and silanized before adhesive cementation

Eligibility criteria

Inclusion Criteria: * No systemic contraindications to prosthodontic treatment * Adequate oral hygiene * Signed informed consent to participate in the study * Posterior teeth (premolars or molars) * Involvement of the entire occlusal surface * Partial- or full-coverage lithium disilicate ceramic restoration * Vital and healthy dental pulp Exclusion Criteria: * Orofacial pain * Allergy to latex, dental composites, or acrylates * Pregnancy or breastfeeding * Clinical signs of periodontal or periapical inflammation * Dentin hypersensitivity * Pain on biting or spontaneous pain * Pathological findings on dental radiographs * Untreated periodontal disease * Hypoplastic enamel defects

Conditions

Prosthodontics Dental Adhesives/Restorations Performance Crowned Posterior Teeth

Locations

  • Faculty of Medicine, University of Ljubljana — Ljubljana, Slovenia
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record