Restoration of Posterior ToothNCT07043998
Evaluation of Full Veneered Porcelain-Fused-to-Metal Crowns Cemented With Self-Adhesive Resin Cement Using Two Curing Modes
A study testing Self-adhesive resin cement in SELF-CURED mode and Self-adhesive resin cement in DUAL-CURED mode in people with Restoration of Posterior Tooth, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Restoration of Posterior Tooth
- What is being tested?
- Self-adhesive resin cement in SELF-CURED mode and Self-adhesive resin cement in DUAL-CURED mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Inability to comply with study requirements
- Current participation in other dental clinical trials
- Active orthodontic treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Full Veneered Porcelain-Fused-to-Metal Crowns Cemented With Self-Adhesive Resin Cement Using Two Curing Modes: A Randomized Clinical Trial
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
- Conditions
- Restoration of Posterior Tooth
- Being tested
- Self-adhesive resin cement in SELF-CURED mode, Self-adhesive resin cement in DUAL-CURED mode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-adhesive resin cement in SELF-CURED modeOther
PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in SELF-CURED mode
Self-adhesive resin cement in DUAL-CURED modeOther
PFM crowns veneered with porcelain system cemented using self-adhesive resin cement in DUAL-CURED mode
| Study group | Role | What they receive |
|---|---|---|
| Adult patients requiring PFM crown cemented with dual cured self adhesive resin cement | Active comparator | Not described Receives: Other: Self-adhesive resin cement in DUAL-CURED mode |
| Adult patients requiring PFM crown cemented with self cured self adhesive resin cement | Active comparator | Not described Receives: Other: Self-adhesive resin cement in SELF-CURED mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of PFM crowns
Modified USPHS criteria (Scores)
Measured: 18 months
Secondary outcomes (3)
Marginal adaptation
Modified USPHS criteria ( scores)
Measured: 18 months
Recurrent caries
Modified USPHS criteria ( scores)
Measured: 18 months
Marginal discoloration
Modified USPHS criteria ( scores)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 May 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Posterior ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Nabil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043998
- Sponsor's protocol ID
- 24/5/25
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Full Veneered Porcelain-Fused-to-Metal Crowns Cemented With Self-Adhesive Resin Cement Using Two Curing Modes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07043998
- Acronym / sponsor ID
- 24/5/25
- Conditions
- Restoration of Posterior Tooth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult patients requiring PFM crown cemented with dual cured self adhesive resin cement | Active comparator | Other: Self-adhesive resin cement in DUAL-CURED mode |
| Adult patients requiring PFM crown cemented with self cured self adhesive resin cement | Active comparator | Other: Self-adhesive resin cement in SELF-CURED mode |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-adhesive resin cement in SELF-CURED modePFM crowns veneered with porcelain system cemented using self-adhesive resin cement in SELF-CURED mode | Other | Adult patients requiring PFM crown cemented with self cured self adhesive resin cement |
| Self-adhesive resin cement in DUAL-CURED modePFM crowns veneered with porcelain system cemented using self-adhesive resin cement in DUAL-CURED mode | Other | Adult patients requiring PFM crown cemented with dual cured self adhesive resin cement |
Primary outcome
Retention of PFM crowns
Time frame: 18 months
Modified USPHS criteria (Scores)
3 secondary outcomes
Marginal adaptation
Time frame: 18 months
Recurrent caries
Time frame: 18 months
Marginal discoloration
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Clinical Evaluation of Indirect Tooth-Colored Onlays With Cervical Margin Relocation
Indirect Tooth-colored Onlay Restorations in Posterior Teeth, Clinical Performance of Cervical-margin-relocated Onlay Restorations
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Direct Versus Indirect Endocrowns on Endodontically Treated Molars
Endodontically-Treated Teeth, Endocrown Restoration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-adhesive resin cement in SELF-CURED mode and Self-adhesive resin cement in DUAL-CURED mode in people with Restoration of Posterior Tooth, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia Nabil, Associate Professor (+201222201179, omnianabil@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of PFM crowns (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.