Relation of Caries Color to Caries Severity and Its Microbial Load

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relation of Caries Color
• Intervention / Treatment: Other: dark brown color of caries; Other: light brown color of caries; Other: yellow color of caries; Other: Black color of caries

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Their ages ranged from (4 to 7) years.
2. 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.
3. Primary molars with class 1 caries, normal furcation and normal periapical bone structure
4. They were indicated for restorative treatment under local anesthesia.
5. They were not indicated for pharmacological management

Exclusion Criteria:

1. Primary molars with class 2 caries
2. Teeth with mobility
3. Periapical abscess
4. Fistula

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Black caries color	Other: dark brown color of caries; 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; Other: light brown color of caries; 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; Other: yellow color of caries; 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
Experimental: Group 2; Dark brown caries color	Other: light brown color of caries; 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; Other: yellow color of caries; 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; Other: Black color of caries; 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
Experimental: Group 3; Light brown caries color	Other: dark brown color of caries; 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; Other: yellow color of caries; 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; Other: Black color of caries; 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
Experimental: Group 4; Yellow caries color	Other: dark brown color of caries; 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; Other: light brown color of caries; 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; Other: Black color of caries; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 )	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)	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)	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 )	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Salwa M Awad, prof, Prof. of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Mansoura University; Principal Investigator: Khaled A Habbal, Master, Researcher of Pediatric Dentistry , Faculty of Dentistry Mansoura University; Study Director: Hossam E Hammouda, PhD, Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: ICDAS; Microbial load; Radiograph; Relation of Caries Color; History of pain; Caries severity
• Other Study ID Numbers: A26020822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No