Proximal Caries Clinical Trial
Official title:
Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries: A Randomized Controlled Clinical Trial
Verified date | March 2021 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with fluoride varnish (MI Varnish™) sodium fluoride (NaF) varnish (Profluorid® Varnish). The study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 8, 2021 |
Est. primary completion date | December 6, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 13 Years |
Eligibility | Inclusion Criteria: - Children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth, - Non-cavitated proximal carious lesions which is radiographically extending into either the outer half of the enamel (E1), the inner half of the enamel (E2) or the outer third of the dentin (D1), - Children who had not any systemic disease that prevents the application, - Cooperative children who allowed to radiographic examinations and clinical applications. Exclusion Criteria: - There is caries/restoration on the different surface of the tooth to be treated, - There is caries/restoration on the contact surface of the tooth adjacent to the tooth to be treated, - Non-cavitated proximal carious lesions which is radiographically extending into the middle third of the dentin (D2) or the inner third of the dentin (D3), - There is cavitation on the proximal surface of the tooth to be treated, - Non-cooperative children who had not allow to radiographic examinations and clinical applications, - Children and parents who denied the participation in the follow-up appointments. |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Katip Celebi Uni. | Izmir | |
Turkey | Izmir Katip Celebi University | Izmir |
Lead Sponsor | Collaborator |
---|---|
Izmir Katip Celebi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The assessment of lesion progression by digital subtraction radiography (DSR) | The primary outcome of the study was assessment of lesion progression (change in the lesions' opacity) by DSR readings, at 12th month. | 12 months after the clinical applications | |
Secondary | The assessment of lesion progression by pair-wise visual reading of radiographs | One of the secondary outcomes of the study was assessment of lesion progression (change in the lesions' opacity) assessed by pair-wise visual readings, at 12th month. | 12 months after the clinical applications | |
Secondary | The assessment of lesion progression by independent visual reading of radiographs | The other one of the secondary outcomes of the study was assessment lesion progression (change in the classification of the lesions' size with respect to E0-E2, D1-D3 radiographic scoring system) assessed by independent visual readings, at 12th month. | 12 months after the clinical applications |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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