Clinical trial NCT05236205: Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions
Official title: Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions - Study Protocol for a Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Caries
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alternatively to conventional treatments, chemo-mechanical caries removal agents can be used. A modality of treatment that has been increasing in dentistry is antimicrobial photodynamic therapy (aPDT). Bixa orellana, is being researched for application in aPDT. This protocol aims to determine the effectiveness of aPDT with Bixa orellana extract in deep caries lesions. Methods and analysis: A total of 160 teeth with deep occlusal dental caries will be selected and divided in 3 groups: G1 - control group (Caries removal with a lowspeed drill); G2 - Partial Caries Removal with Papacarie; G3 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%); G4 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%) with LED (aPDT). After treatment, all the teeth will be restored with glass ionomer cement and followed up clinically and radiographically, with evaluations at immediately, 1 week, 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The data will be submitted to descriptive statistical analysis of the association between the categorical variables using the chi-square test and Fisher exact text. The Student t test and analysis of variance will be used for the comparison of mean signs and symptoms of reversible pulpitis. Pearson correlation coefficients will be calculated for the analysis of correlations among the continuous variables.


Eligibility criteria: Inclusion Criteria:

* Adequate health with no systemic conditions;
* Adequate cooperation;
* Clinically presenting at least 1 permanent molar with an acute, active caries on the dentin not surpassing 2/3 and only involving the occlusal face, with direct view and access as well as no clinical or radiographic signs of pulp involvement.

Exclusion Criteria:

* Systemic adverse health condition;
* Uncooperative behavior;
* Class II, III, IV, or V carious lesion based on Black classification;
* Clinically: caries involving enamel, deficient restorations, small carious lesions on dentin with no access for manual scalers, hidden caries, sign or symptom of pulp involvement, clinical impossibility of restoration;
* Radiographically: evidence of pulp involvement, carious lesion extending beyond 2/3 of dentin.

Primary outcomes:
measure: Changes in Microbiological Evaluation
timeFrame: Baseline and immediately after treatment.
Secondary outcomes:
measure: Changes in Radiographic evaluation
timeFrame: Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
measure: Evaluation of time required for procedure
timeFrame: During the procedure.
measure: Evaluation of need for local anesthesia during intervention
timeFrame: During the procedure.
measure: Changes in Clinical Evaluation
timeFrame: Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
measure: Degree of pain/discomfort of children during procedure
timeFrame: During the procedure.
Other outcomes:
Locations:
Study officials:
References: