Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions

NCT05236205 | Unknown Phase 2

• 1 other identifier: UrucumCaries
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries

Outcome Measures

Primary Outcomes (1)

• Changes in Microbiological Evaluation

  A sample of caries-affected dentin will be taken from each selected tooth before the removal of the carious tissue. All procedures will be performed in duplicate, and the mean of the counts will be calculated. The results will be expressed in CFU of SM and LB as well as in proportion of streptococcus (% S/VM), SM group (% SM/VM and lactobacilli (% LB/VM) in relation to the total of VM. Immediately after the removal of the carious tissue, samples of the remaining dentin will be taken with a Meyhoefer auricular n° 2 curette and the procedures will be repeated.

  Baseline and immediately after treatment.

Secondary Outcomes (5)

• Changes in Radiographic evaluation

  Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.

• Evaluation of time required for procedure

  During the procedure.

• Evaluation of need for local anesthesia during intervention

  During the procedure.

• Changes in Clinical Evaluation

  Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.

• Degree of pain/discomfort of children during procedure

  During the procedure.

Study Arms (4)

Control Group

EXPERIMENTAL

This group will receive the treatment of caries removal with a lowspeed drill (conventional treatment).

Procedure: Caries removal with a lowspeed drill

Papacarie

EXPERIMENTAL

In this group, partial caries removal with Papacarie will be performed.

Procedure: Partial removal of carious tissue with the administration of Papacarie™

Papacarie and Bixa orellana extract

EXPERIMENTAL

In this group, partial caries removal with Papacarie and the application of Bixa orellana extract (20%) will be performed.

Procedure: Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)

Partial removal with aPDT

EXPERIMENTAL

In this group, partial removal of the carious tissue will be performed, with Papacarie and the application of Bixa orellana extract (20%) with blue LED (aPDT).

Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)

Interventions

Caries removal with a lowspeed drill PROCEDURE

1. Initial periapical and interproximal radiographs; 2. Prophylaxis with toothbrush and fluoride toothpaste; 3. Relative isolation with lip bumper, cotton roll, and aspirator; 4. Microbiological sampling with ear curette for standardization of volume of carious tissue; 5. Removal of carious dentin with carbide burs and manual instruments; 6. Additional microbiological sampling; 7. Clinical inspection of texture of remaining dentin with an exploratory probe; 8. Restoration with glass ionomer cement (Ketac Molar Easy Mix - 3M ESPE); 9. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months.

Control Group

Partial removal of carious tissue with the administration of Papacarie™ PROCEDURE

1. Initial radiographs; 2. Relative isolation; 3. Microbiological sample with otoscope curette to standardize volume of carious tissue; 4. Application of Papacarie™ for 5 m inutes, removal of carious tissue around lateral walls of the cavity with noncutting curette and no removal of carious tissue on pulp floor; 5. Second microbiological sample of remaining dentin with curette; 6. Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; 7. Restoration with glass ionomer cement; 8. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.

Papacarie

Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%) PROCEDURE

1. Initial radiographs; 2. Relative isolation; 3. Microbiological sample with otoscope curette to standardize volume of carious tissue; 4. Application of Papacarie™ with Bixa Orellana extract (20%) for 5 minutes, removal of carious tissue around lateral walls of the cavity with noncutting curette; 5. Irradiation of dental tissue for 1 minute on a single point; 6. Second microbiological sample of remaining dentin with curette; 7. Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; 8. Restoration with glass ionomer cement; 9. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.

Papacarie and Bixa orellana extract

Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT) PROCEDURE

1. Initial radiographs; 2. Relative isolation; 3. Microbiological sample with otoscope curette to standardize volume of carious tissue; 4. Application of Papacarie™ with Bixa Orellana extract (20%) for 5 minutes and the blue light-emitting diode (LED) irradiation with 440-480 nm. Removal of carious tissue around lateral walls of the cavity with noncutting curette; 5. Irradiation of dental tissue for 1 minute on a single point; 6. Second microbiological sample of remaining dentin with curette; 7. Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; 8. Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); 9. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.

Partial removal with aPDT

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• Martins LFB, de Sena LR, de Paula DM, Feitosa VP, Horliana ACRT, Fernandes KPS, Mesquita-Ferrari RA, Motta LJ, Goncalves MLL, Bussadori SK. Investigation on the effect of antimicrobial photodynamic therapy as an adjunct for management of deep caries lesions-study protocol for a randomized, parallel groups, controlled clinical trial. Trials. 2023 Mar 4;24(1):165. doi: 10.1186/s13063-023-07181-8.

  PMID: 36870982 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical evaluations of the carious tissue removal, as well as the microbiological and radiographic analyses, will be performed by examiners blinded to the treatments performed on each tooth.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 11, 2022
• Study Start: May 30, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 20, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05