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RecruitingNCT07043998Updated Jun 29, 2025

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

An interventional study of Self-adhesive resin cement in SELF-CURED mode and Self-adhesive resin cement in DUAL-CURED mode in Restoration of Posterior Tooth, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • Restoration of Posterior Tooth
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with active periodontal disease (probing depth > 4mm, bleeding on probing)
  2. Patients with severe parafunctional habits (e.g., bruxism confirmed by clinical examination)
  3. Poor oral hygiene (plaque index > 30%)
  4. Pregnancy or nursing
  5. Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
  6. Known allergies to study materials (metal alloys, porcelain, or resin cement components)
  7. Inability to comply with study requirements
  8. Current participation in other dental clinical trials
  9. Active orthodontic treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Active comparator
    Adult patients requiring PFM crown cemented with dual cured self adhesive resin cement

    Other: Self-adhesive resin cement in DUAL-CURED mode

  • Active comparator
    Adult patients requiring PFM crown cemented with self cured self adhesive resin cement

    Other: Self-adhesive resin cement in SELF-CURED mode

Interventions

  • OtherSelf-adhesive resin cement in SELF-CURED mode

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

  • OtherSelf-adhesive resin cement in DUAL-CURED mode

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

06

What researchers measure

Primary outcomes

  1. Retention of PFM crowns

    Modified USPHS criteria (Scores)

    Time frame: 18 months

Secondary outcomes

  1. Marginal adaptation

    Modified USPHS criteria ( scores)

    Time frame: 18 months

  2. Recurrent caries

    Modified USPHS criteria ( scores)

    Time frame: 18 months

  3. Marginal discoloration

    Modified USPHS criteria ( scores)

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry Cairo University
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07043998
Lead sponsor
Cairo University
Responsible party
Omnia Nabil (Associate Professor, Cairo University) — Principal investigator
First posted
Jun 29, 2025
Start date
May 15, 2025
Primary completion
Dec 15, 2026 (estimated)
Completion
Jun 15, 2027 (estimated)
Last update
Jun 29, 2025

Study contacts

Omnia Nabil, Associate Professor
Contact
omnianabil@dentistry.cu.edu.eg
+201222201179

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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