Status:
COMPLETED
Evaluation of the Chemo-mechanical Caries Removal Agent (BRIX3000®) in Primary Molars
Lead Sponsor:
King Abdulaziz University
Conditions:
Dental Caries
Eligibility:
All Genders
4-9 years
Phase:
NA
Brief Summary
Dental caries is one of the most prevalent chronic diseases in people worldwide. Traditional clinical treatment of dental decay has developed on the basis of the removal of carious tissues with high-s...
Detailed Description
Dental caries is one of the most prevalent chronic diseases in people worldwide. It results in localized dissolution and destruction of the calcified tooth tissues. The destruction of the dental struc...
Eligibility Criteria
Inclusion
- Healthy and cooperative patients of age group 4-9 years.
- Primary first/second molars with open occlusal carious lesion having moderated depth and clinically visible brownish color softened dentin.
- No clinical signs or symptoms of pulp degeneration, such as tenderness to percussion and history of sinus tracts or swelling. Intraoral periapical radiographs with lesions having radiolucency extending into, but only confined to dentin.
Exclusion
- Patients with any major and minor systemic illness.
- Uncooperative patients that necessitate pharmacological dental treatment.
- Primary molars with mobile teeth, arrested caries, restored teeth, non-vital teeth, no carious lesion, presence of developmental defects and non-restorable teeth.
- Patients on any antibiotic regimen either on the day of treatment or for at least 2 weeks prior to the study.
- Patients allergic to Latex.
- Radiographic evidence of external or internal root resorption, furcal or periapical radiolucency.
- Primary molars with more than half of the root length resorbed.
- Children who did not attend and complete the second session of treatment.
- Not approving to sign the consent.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05427591
Start Date
October 1 2019
End Date
January 1 2021
Last Update
June 22 2022
Active Locations (1)
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1
King Abdulaziz University, Dental University Hospital
Jeddah, Mecca Region, Saudi Arabia, 80209