Class IV Dental CariesShade MatchingNCT06827847
Comparative Evaluation of Shade Matching Using a Digital Spectrophotometer in Monochromatic Versus Polychromatic Layering Techniques for Restoring Fractured Incisal Angles of Maxillary Incisors - Invivo Study
A study testing Traditional polychromatic layering dental composite technique and Contemporary monochromatic single shade dental composite technique in people with Class IV Dental Caries, run by Badr University at 1 site in Egypt.
Trial summary
The color and appearance of a tooth is complex phenomenon which is related to many factors such as color stability, The Blending Effect, color Induction, color assimilation effect of resin composite materials which are all fall under the Term Chameleon Effect Which Enables Resin composite material to obtain a shade… Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Class IV Dental Caries
- What is being tested?
- Traditional polychromatic layering dental composite technique and Contemporary monochromatic single shade dental composite technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to 25 Jan 2025
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- fractured incisal angles in vital maxillary permanent incisors
- aged 16 to 35
- exhibits good oral hygiene
Who cannot join
- individuals with nonvital or endodontically treated teeth
- active periodontal disease
- significant medical complications
- malocclusion
- parafunctional habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Shade Matching Using a Digital Spectrophotometer in Monochromatic Versus Polychromatic Layering Techniques for Restoring Fractured Incisal Angles of Maxillary Incisors: a Randomized Controlled Trial
The color and appearance of a tooth is complex phenomenon which is related to many factors such as color stability, The Blending Effect, color Induction, color assimilation effect of resin composite materials which are all fall under the Term Chameleon Effect Which Enables Resin composite material to obtain a shade that bears a resemblance to the color of the surrounding tooth structure. The usage of different opacities and shades to match the tooth structure is very time consuming for both patient and clinician. However, any clinical effectiveness of any dental restorative procedures such as composite replacement is dependent on their physical, chemical and mechanical features which are highly proportional with oral environment and resin material properties.
Read the detailed description
Resin Composite Material allow light scattering between Enamel and Dentin Which aid in Internal diffusion So That Resin Composite Material blend with the surroundings. The color alteration Also is directly proportional with light absorption to make it undetectable when blended with tooth structure A Significant disadvantage of resin composite restorations is highly susceptibility to staining and discoloration by the time and aging process in the oral environment. Color instability is one of the main reasons for replacing restorations, particularly in anterior teeth. There are several factors that affect the color stability of resin composite including intrinsic factors, namely the chemical make-up of the materials. Moreover, other extrinsic factors including smoking and poor oral hygiene, as well as the absorption of dyes from consuming foods and beverages in the oral cavity influence the color stability of resin composite restoration.
The color of any observed restoration is dedicated by light scattering between resin composite material and other substrates such as Tooth structure beneath restoration and other hard dental tissues. Natural teeth and resin composite material should share Three basic parameters Chroma , Hue and Value . Other Parameters effect on observation such as opacity, translucency, glossy surface should be put in consideration During resin based composite manufacturing.
This investigation sought to determine the effectiveness of three distinct approaches to shade matching when restoring class iv in dental maxillary incisors using universal Universal shade dental composite technique, traditional polychromatic layering dental composite technique, and contemporary monochromatic single shade dental composite technique.
- Conditions
- Class IV Dental Caries
- Being tested
- Traditional polychromatic layering dental composite technique, Contemporary monochromatic single shade dental composite technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional polychromatic layering dental composite techniqueProcedure or surgery
patient received composite restoration done by layering technique
Contemporary monochromatic single shade dental composite techniqueProcedure or surgery
patient received composite restoration done by single shade composite
| Study group | Role | What they receive |
|---|---|---|
| Universal shade dental composite technique | Active comparator | patient received composite restoration done by received universal composite material Receives: Procedure: Traditional polychromatic layering dental composite technique; Procedure: Contemporary monochromatic single shade dental composite technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shade matching
Shade selection will be evaluated using Vita Easyshade which is a hand-held digital spectro-photometer that consists of a hand piece connected to a base unit by a monocoil fiber optic cable assembly with a probe tip of about 5 mm in diameter, before and after putting esthetic restorations, then different resin composite shading systems will be used in this study
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Jan 2025
- Primary completion22 Jan 2025
- Study completion25 Jan 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed Adel Abdelaziz, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827847
- Sponsor's protocol ID
- BUC-IACUC-250119-127
- Acronym
- Shade Matching
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 14 Feb 2025
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Shade Matching Using a Digital Spectrophotometer in Monochromatic Versus Polychromatic Layering Techniques for Restoring Fractured Incisal Angles of Maxillary Incisors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06827847
- Acronym / sponsor ID
- Shade Matching / BUC-IACUC-250119-127
- Conditions
- Class IV Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 14 Feb 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.
The color and appearance of a tooth is complex phenomenon which is related to many factors such as color stability, The Blending Effect, color Induction, color assimilation effect of resin composite materials which are all fall under the Term Chameleon Effect Which Enables Resin composite material to obtain a shade that bears a resemblance to the color of the surrounding tooth structure. The usage of different opacities and shades to match the tooth structure is very time consuming for both patient and clinician. However, any clinical effectiveness of any dental restorative procedures such as composite replacement is dependent on their physical, chemical and mechanical features which are highly proportional with oral environment and resin material properties.
Detailed description
Resin Composite Material allow light scattering between Enamel and Dentin Which aid in Internal diffusion So That Resin Composite Material blend with the surroundings. The color alteration Also is directly proportional with light absorption to make it undetectable when blended with tooth structure A Significant disadvantage of resin composite restorations is highly susceptibility to staining and discoloration by the time and aging process in the oral environment. Color instability is one of the main reasons for replacing restorations, particularly in anterior teeth. There are several factors that affect the color stability of resin composite including intrinsic factors, namely the chemical make-up of the materials. Moreover, other extrinsic factors including smoking and poor oral hygiene, as well as the absorption of dyes from consuming foods and beverages in the oral cavity influence the color stability of resin composite restoration.
The color of any observed restoration is dedicated by light scattering between resin composite material and other substrates such as Tooth structure beneath restoration and other hard dental tissues. Natural teeth and resin composite material should share Three basic parameters Chroma , Hue and Value . Other Parameters effect on observation such as opacity, translucency, glossy surface should be put in consideration During resin based composite manufacturing.
This investigation sought to determine the effectiveness of three distinct approaches to shade matching when restoring class iv in dental maxillary incisors using universal Universal shade dental composite technique, traditional polychromatic layering dental composite technique, and contemporary monochromatic single shade dental composite technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Universal shade dental composite technique | Active comparator | Procedure: Traditional polychromatic layering dental composite technique, Procedure: Contemporary monochromatic single shade dental composite techniquepatient received composite restoration done by received universal composite material |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- fractured incisal angles in vital maxillary permanent incisors
- aged 16 to 35
- exhibits good oral hygiene
Key exclusion criteria (5 listed)
- individuals with nonvital or endodontically treated teeth
- active periodontal disease
- significant medical complications
- malocclusion
- parafunctional habits
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 |
|---|---|---|
| Traditional polychromatic layering dental composite techniquepatient received composite restoration done by layering technique | Procedure or surgery | Universal shade dental composite technique |
| Contemporary monochromatic single shade dental composite techniquepatient received composite restoration done by single shade composite | Procedure or surgery | Universal shade dental composite technique |
Primary outcome
Shade matching
Time frame: 1 day
Shade selection will be evaluated using Vita Easyshade which is a hand-held digital spectro-photometer that consists of a hand piece connected to a base unit by a monocoil fiber optic cable assembly with a probe tip of about 5 mm in diameter, before and after putting esthetic restorations, then different resin composite shading systems will be used in this study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional polychromatic layering dental composite technique and Contemporary monochromatic single shade dental composite technique 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 1 day). 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 14 Feb 2025.