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

NCT ID: NCT07043998

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2027-06-15

Brief Summary

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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

Detailed Description

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Conditions

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Restoration of Posterior Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

Group Type ACTIVE_COMPARATOR

Self-adhesive resin cement in DUAL-CURED mode

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Self-adhesive resin cement in SELF-CURED mode

Intervention Type OTHER

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

Interventions

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Self-adhesive resin cement in SELF-CURED mode

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

Intervention Type OTHER

Self-adhesive resin cement in DUAL-CURED mode

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

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Omnia Nabil

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Omnia Nabil, Associate Professor

Role: CONTACT

Phone: +201222201179

Email: [email protected]

Other Identifiers

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24/5/25

Identifier Type: -

Identifier Source: org_study_id