Relation of Caries Color to Caries Severity and Its Microbial Load

Not Applicable

Active, not recruiting

• Conditions: Relation of Caries Color

• Registration Number: NCT06338540
• Lead Sponsor: Mansoura University

Brief Summary

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 Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-08
• Primary Completion: 2024-01-01
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caries color related to history of pain	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	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	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	Up to 12 weeks	Four caries color ( black , dark brown , light brown , yellow ) related to microbial load ( Streptococci mutans and Lactobacilli for caries biopsy )

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Mansoura, Dakahlia, Egypt