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Recruiting

NCT Number: NCT07043998

Evaluation of Full Veneered Porcelain-Fused-to-Metal Crowns Cemented With Self-Adhesive Resin Cement Using Two Curing Modes

P - Population/Patient Problem Adult patients requiring full coverage porcelain-fused-to-metal (PFM) crown restorations I - Intervention PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in DUAL-CURED mode (light-cured for 20 seconds per surface) C - Comparison PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in SELF-CURED mode (no light curing, 5 minutes self-cure) O - Outcome(s)

* Primary: Retention of PFM crowns (Modified USPHS criteria) * Secondary: Marginal adaptation, recurrent caries, marginal discoloration (Modified USPHS criteria) T - Time 18-month follow-up period with evaluations at baseline, 6, 12, and 18 months

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients requiring full coverage PFM crown restorations
  • Age ≥ 21 years
  • Vital or endodontically treated teeth
  • Sufficient tooth structure for crown retention
  • Willing and able to provide written informed consent
  • Ability to attend all follow-up appointments
  • Adequate oral hygiene as determined by the investigator

Exclusion criteria

  • Patients with active periodontal disease (probing depth > 4mm, bleeding on probing)
  • Patients with severe parafunctional habits (e.g., bruxism confirmed by clinical examination)
  • Poor oral hygiene (plaque index > 30%)
  • Pregnancy or nursing
  • Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
  • Known allergies to study materials (metal alloys, porcelain, or resin cement components)
  • Inability to comply with study requirements
  • Current participation in other dental clinical trials
  • Active orthodontic treatment

Treatment and study plan

Self-adhesive resin cement in SELF-CURED mode

Other

PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in SELF-CURED mode

Self-adhesive resin cement in DUAL-CURED mode

Other

PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in DUAL-CURED mode

Primary outcomes

  1. Retention of PFM crowns

    Time frame: 18 months

    Modified USPHS criteria (Scores)

Secondary outcomes

  1. Marginal adaptation

    Time frame: 18 months

    Modified USPHS criteria ( scores)

  2. Recurrent caries

    Time frame: 18 months

    Modified USPHS criteria ( scores)

  3. Marginal discoloration

    Time frame: 18 months

    Modified USPHS criteria ( scores)

Study contacts

Contact information is provided by the study sponsor or research team.

Omnia Nabil, Associate Professor

CONTACT

[email protected]

+201222201179

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Full Veneered Porcelain-Fused-to-Metal Crowns Cemented With Self-Adhesive Resin Cement Using Two Curing Modes: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.