Relation of Caries ColorNCT06338540

Relation of Caries Color to Caries Severity and Its Microbial Load

A study testing Black color of caries, dark brown color of caries and light brown color of caries in people with Relation of Caries Color, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is to find the relation of caries color to caries severity and its microbial load in primary molars. Read more about this study

Who is it for?: Ages 4 to 7 years
Conditions the study is for: Relation of Caries Color
What is being tested?: Black color of caries, dark brown color of caries and light brown color of caries
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: 1 Sep 2022to 1 Jul 2024
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 4 to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

Their ages ranged from (4 to 7) years.
They were healthy, free from any chronic disease and had no previous anxiety disorder or medical disability such as the history of seizures or convulsion disorders, nystagmus, vertigo or equilibrium disorders, eye problems and autism.
Primary molars with class 1 caries, normal furcation and normal periapical bone structure
They were indicated for restorative treatment under local anesthesia.
They were not indicated for pharmacological management

Who cannot join

Primary molars with class 2 caries
Teeth with mobility
Periapical abscess
Fistula

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mansoura university
Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

Official title: Relation of Caries Color to Caries Severity and Its Microbial Load in Primary Molars. A Clinical Study

This study is to find the relation of caries color to caries severity and its microbial load in primary molars.

Read the detailed description

This study is to investigate the relationship between the caries color to caries severity and its microbial load.

Conditions: Relation of Caries Color
Being tested: Black color of caries, dark brown color of caries, light brown color of caries, yellow color of caries
Keywords: Relation of Caries Color, History of pain, Caries severity, ICDAS, Microbial load, Radiograph

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Black color of cariesOther
observation of the dental caries color will be confirmed with standardized photographs illustrating , the black caries color related to history of pain , ICDAS , pulp exposed and microbial load
dark brown color of cariesOther
observation of the dental caries color will be confirmed with standardized photographs illustrating , the dark brown caries color related to history of pain , ICDAS , pulp exposed and microbial load
light brown color of cariesOther
observation of the dental caries color will be confirmed with standardized photographs illustrating , the light brown caries color related to history of pain , ICDAS , pulp exposed and microbial load
yellow color of cariesOther
observation of the dental caries color will be confirmed with standardized photographs illustrating , the yellow caries color related to history of pain , ICDAS , pulp exposed and microbial load

Study groups in NCT06338540
Study group	Role	What they receive
Group 1	Experimental	Black caries color Receives: Other: dark brown color of caries; Other: light brown color of caries; Other: yellow color of caries
Group 2	Experimental	Dark brown caries color Receives: Other: Black color of caries; Other: light brown color of caries; Other: yellow color of caries
Group 3	Experimental	Light brown caries color Receives: Other: Black color of caries; Other: dark brown color of caries; Other: yellow color of caries
Group 4	Experimental	Yellow caries color Receives: Other: Black color of caries; Other: dark brown color of caries; Other: light brown color of caries

What is being measured

The primary outcome is the main question the study is designed to answer.

Caries color related to history of pain
Four caries color ( black , dark brown , light brown , yellow ) related to history of pain ( no pain, positive elicited pain, spontaneous pain, and nocturnal pain )
Measured: Up to 12 weeks
Caries color related to ICDAS
Four caries color ( black , dark brown , light brown , yellow ) related to ICDAS ( 3,4,5,6)
Measured: Up to 12 weeks
Caries color related to pulp exposed
Four caries color ( black , dark brown , light brown , yellow ) related to pulp exposed ( pulp exposed , no pulp exposed)
Measured: Up to 12 weeks
Caries color related to microbial load
Four caries color ( black , dark brown , light brown , yellow ) related to microbial load ( Streptococci mutans and Lactobacilli for caries biopsy )
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20221 Jul 2024

First posted29 Mar 2024
Study start1 Sep 2022
Primary completion1 Jan 2024
Study completion1 Jul 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relation of Caries ColorStudies of the same condition, open and under way.
More trials run by Mansoura 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06338540
Sponsor's protocol ID: A26020822
Status last verified: Aug 2023
First submitted: 14 Feb 2024
Last updated: 29 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relation of Caries Color to Caries Severity and Its Microbial Load in Primary Molars. A Clinical Study
ClinicalTrials.gov ID: NCT06338540
Acronym / sponsor ID: A26020822
Conditions: Relation of Caries Color
Keywords: Relation of Caries Color, History of pain, Caries severity, ICDAS, Microbial load, Radiograph
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 1 Sep 2022 (actual)
Primary completion: 1 Jan 2024 (actual)
Study completion: 1 Jul 2024 (estimated)
First posted: 29 Mar 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.

This study is to find the relation of caries color to caries severity and its microbial load in primary molars.

Detailed description

This study is to investigate the relationship between the caries color to caries severity and its microbial load.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color

Arm	Type	Receives
Group 1	Experimental	Other: dark brown color of caries, Other: light brown color of caries, Other: yellow color of cariesBlack caries color
Group 2	Experimental	Other: Black color of caries, Other: light brown color of caries, Other: yellow color of cariesDark brown caries color
Group 3	Experimental	Other: Black color of caries, Other: dark brown color of caries, Other: yellow color of cariesLight brown caries color
Group 4	Experimental	Other: Black color of caries, Other: dark brown color of caries, Other: light brown color of cariesYellow caries color

Who may qualify

Ages: 4 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Their ages ranged from (4 to 7) years.
They were healthy, free from any chronic disease and had no previous anxiety disorder or medical disability such as the history of seizures or convulsion disorders, nystagmus, vertigo or equilibrium disorders, eye problems and autism.
Primary molars with class 1 caries, normal furcation and normal periapical bone structure
They were indicated for restorative treatment under local anesthesia.
They were not indicated for pharmacological management

Key exclusion criteria (4 listed)

Primary molars with class 2 caries
Teeth with mobility
Periapical abscess
Fistula

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
Black color of cariesobservation of the dental caries color will be confirmed with standardized photographs illustrating , the black caries color related to history of pain , ICDAS , pulp exposed and microbial load	Other	Group 2, Group 3, Group 4
dark brown color of cariesobservation of the dental caries color will be confirmed with standardized photographs illustrating , the dark brown caries color related to history of pain , ICDAS , pulp exposed and microbial load	Other	Group 1, Group 3, Group 4
light brown color of cariesobservation of the dental caries color will be confirmed with standardized photographs illustrating , the light brown caries color related to history of pain , ICDAS , pulp exposed and microbial load	Other	Group 1, Group 2, Group 4
yellow color of cariesobservation of the dental caries color will be confirmed with standardized photographs illustrating , the yellow caries color related to history of pain , ICDAS , pulp exposed and microbial load	Other	Group 1, Group 2, Group 3

Primary outcome

Caries color related to history of pain
Time frame: Up to 12 weeks
Four caries color ( black , dark brown , light brown , yellow ) related to history of pain ( no pain, positive elicited pain, spontaneous pain, and nocturnal pain )
Caries color related to ICDAS
Time frame: Up to 12 weeks
Four caries color ( black , dark brown , light brown , yellow ) related to ICDAS ( 3,4,5,6)
Caries color related to pulp exposed
Time frame: Up to 12 weeks
Four caries color ( black , dark brown , light brown , yellow ) related to pulp exposed ( pulp exposed , no pulp exposed)
Caries color related to microbial load
Time frame: Up to 12 weeks
Four caries color ( black , dark brown , light brown , yellow ) related to microbial load ( Streptococci mutans and Lactobacilli for caries biopsy )

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.

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.

Khaled A Habbal, Master principal investigator

Researcher of Pediatric Dentistry , Faculty of Dentistry Mansoura University

Salwa M Awad, Prof study director

Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University

Hossam E Hammouda, PhD study director

Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Black color of caries, dark brown color of caries and light brown color of caries in people with Relation of Caries Color, run by Mansoura 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 5 inclusion and 4 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 29 Mar 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?

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?

Caries color related to history of pain (time frame: Up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06338540.

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 Mar 2024.