Class IV Dental CariesNCT06743984
Evaluate the Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors Using Universal , Layering & One Shade Composite In-vivo on Patients
A study testing Polychromatic resin composite and Monochromatic resin composite in people with Class IV Dental Caries, run by Badr University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate shade matching ability of different techniques of application and different materials of resin composite restorations in class IV carious lesions Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Class IV Dental Caries
- What is being tested?
- Polychromatic resin composite and Monochromatic resin composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2024to 28 Dec 2024
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- Fractured class IV upper central incisors.
Who cannot join
- 1- cracked teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors: a Randomized Clinical Trial
The goal of this clinical trial is to evaluate shade matching ability of different techniques of application and different materials of resin composite restorations in class IV carious lesions
Read the detailed description
Shade matching cabability of different resin composite materials and different techniques for restoration application, layering versus conventional incremental
- Conditions
- Class IV Dental Caries
- Being tested
- Polychromatic resin composite, Monochromatic resin composite
- Keywords
- Universal resin composite, Monoshade resin composite, Polychromatic composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polychromatic resin compositeOther
Polychromatic layering resin composite (enamel and dentin shades).
Monochromatic resin compositeOther
Monochromatic resin composite (opaquer and dentin shades)
| Study group | Role | What they receive |
|---|---|---|
| Single shade resin composite technique | Active comparator | Nanohybrid single shade resin composite Receives: Other: Polychromatic resin composite; Other: Monochromatic resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
shade matching evaluation
evaluation of color change will be done using easy shade device \& digital camera.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start20 Nov 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class IV Dental CariesStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammad Samy, Badr University
- Investigators
- AHMED A ABDELAZIZ, ASS. PROFESSOR, Study director, BADR UNIVERSITY IN CAIRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743984
- Sponsor's protocol ID
- BUC-IACUC-241117-117
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shade Matching of Polychromatic Versus Monochromatic Composite Layering Techniques in Fractured Class IV Maxillary Central Incisors: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06743984
- Acronym / sponsor ID
- BUC-IACUC-241117-117
- Conditions
- Class IV Dental Caries
- Keywords
- Universal resin composite, Monoshade resin composite, Polychromatic composite
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 20 Dec 2024 (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 goal of this clinical trial is to evaluate shade matching ability of different techniques of application and different materials of resin composite restorations in class IV carious lesions
Detailed description
Shade matching cabability of different resin composite materials and different techniques for restoration application, layering versus conventional incremental
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single shade resin composite technique | Active comparator | Other: Polychromatic resin composite, Other: Monochromatic resin compositeNanohybrid single shade resin composite |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- Fractured class IV upper central incisors.
Key exclusion criteria (1 listed)
- 1- cracked 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 |
|---|---|---|
| Polychromatic resin compositePolychromatic layering resin composite (enamel and dentin shades). | Other | Single shade resin composite technique |
| Monochromatic resin compositeMonochromatic resin composite (opaquer and dentin shades) | Other | Single shade resin composite technique |
Primary outcome
shade matching evaluation
Time frame: 1 months
evaluation of color change will be done using easy shade device \& digital camera.
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 20 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Class IV Dental Caries
Recruiting
Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth
Dental Restoration, Permanent, Dental Caries (Disorder)
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.
AHMED A ABDELAZIZ, ASS. PROFESSOR study director
BADR UNIVERSITY IN CAIRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polychromatic resin composite and Monochromatic resin composite in people with Class IV Dental Caries, run by Badr 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. 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?
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?
shade matching evaluation (time frame: 1 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 20 Dec 2024.