Class V Dental CariesNCT05465850
Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth
A study testing Modified USPHS criteria in people with Class V Dental Caries, run by Cairo University.
Trial summary
The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Class V Dental Caries
- What is being tested?
- Modified USPHS criteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Class V carious lesions in anterior teeth
- Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
Who cannot join
- Deep carious defects ( Close to pulp, less than 1 mm distance)
- Periapical pathology or signs of pulpal pathology
- Endodontically treated teeth
- Tooth hypersensitivity
- Possible prosthodontic restoration of teeth
- Heavy occlusion and occlusal contacts or history of bruxism
Show all 9Show fewer
- Severe periodontal affection
- Lesions in premolars and molars
- Posterior teeth
About this study
Official title: Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up
The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.
- Conditions
- Class V Dental Caries
- Being tested
- Modified USPHS criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified USPHS criteriaDiagnostic test
It assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries.
| Study group | Role | What they receive |
|---|---|---|
| Filtek Z350XT | Active comparator | Not described Receives: Diagnostic Test: Modified USPHS criteria |
| Essentia universal shade, GC composite | Experimental | Not described Receives: Diagnostic Test: Modified USPHS criteria |
| Omnichroma composite | Experimental | Not described Receives: Diagnostic Test: Modified USPHS criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance (USPHS criteria)
USPHS criteria
Measured: baseline: 1 week
Clinical performance (USPHS criteria)
USPHS criteria
Measured: 6 months
Clinical performance (USPHS criteria)
USPHS criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V Dental CariesStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Khaled Mokhtar Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465850
- Sponsor's protocol ID
- 14422019428237
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Matching Potential of Universal Shade Resin Composite Materials Compared to Multi Shade Resin Composite in Restoration of Carious Cervical Lesions in Anterior Teeth ( Randomized Clinical Trial ) - 1 Year Follow up
- ClinicalTrials.gov ID
- NCT05465850
- Acronym / sponsor ID
- 14422019428237
- Conditions
- Class V Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 20 Jul 2022 (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.
The aim of the study is to clinically evaluate the shade matching and clinical performance of the Universal shade composites Omnichroma and GC Essentia versus the multi shade composite Filtek Z350XT in restoring cervical lesions of anterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Filtek Z350XT | Active comparator | Diagnostic Test: Modified USPHS criteria |
| Essentia universal shade, GC composite | Experimental | Diagnostic Test: Modified USPHS criteria |
| Omnichroma composite | Experimental | Diagnostic Test: Modified USPHS criteria |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Class V carious lesions in anterior teeth
- Vital upper or lower anterior teeth with no signs of irreversible pulpitis and necrosis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth
Key exclusion criteria (9 listed)
- Deep carious defects ( Close to pulp, less than 1 mm distance)
- Periapical pathology or signs of pulpal pathology
- Endodontically treated teeth
- Tooth hypersensitivity
- Possible prosthodontic restoration of teeth
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 |
|---|---|---|
| Modified USPHS criteriaIt assess the restorations with visual inspection using a mirror and explorer. It includes Marginal integrity, shade matching, retention, marginal discoloration, gingival inflammation, and recurrent caries. | Diagnostic test | Essentia universal shade, GC composite, Filtek Z350XT, Omnichroma composite |
Primary outcome
Clinical performance (USPHS criteria)
Time frame: baseline: 1 week
USPHS criteria
Clinical performance (USPHS criteria)
Time frame: 6 months
USPHS criteria
Clinical performance (USPHS criteria)
Time frame: 12 months
USPHS criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Modified USPHS criteria in people with Class V Dental Caries, run by Cairo University.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (USPHS criteria) (time frame: baseline: 1 week). The study lists 3 primary outcomes in all. 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 20 Jul 2022.