Relation of Caries Color to Caries Severity and Its Microbial Load

NCT06338540 | Unknown

• 1 other identifier: A26020822
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relation of Caries Color

Keywords

Relation of Caries Color; History of pain; Caries severity; ICDAS; Microbial load; Radiograph

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Group 1

EXPERIMENTAL

Black caries color

Other: dark brown color of caries; Other: light brown color of caries; Other: yellow color of caries

Group 2

EXPERIMENTAL

Dark brown caries color

Other: Black color of caries; Other: light brown color of caries; Other: yellow color of caries

Group 3

EXPERIMENTAL

Light brown caries color

Other: Black color of caries; Other: dark brown color of caries; Other: yellow color of caries

Group 4

EXPERIMENTAL

Yellow caries color

Other: Black color of caries; Other: dark brown color of caries; Other: light brown color of caries

Interventions

Black color of caries OTHER

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

Group 2; Group 3; Group 4

dark brown color of caries OTHER

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

Group 1; Group 3; Group 4

light brown color of caries OTHER

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

Group 1; Group 2; Group 4

yellow color of caries OTHER

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Study Officials

• Khaled A Habbal, Master

  Researcher of Pediatric Dentistry , Faculty of Dentistry Mansoura University

  PRINCIPAL INVESTIGATOR

• Salwa M Awad, Prof

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

  STUDY DIRECTOR

• Hossam E Hammouda, PhD

  Assistant Professor of Pediatric Dentistry Faculty of Dentistry Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: Yellow caries color Group 2: dark brown caries color Group 3: light brown caries color Group 4: black caries color

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 29, 2024
• Study Start: September 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2023-08

Locations

EG (1)