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

NCT ID: NCT05236205

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: EXPERIMENTAL

Caries removal with a lowspeed drill

Intervention Type: 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.

Papacarie

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

Group Type: EXPERIMENTAL

Partial removal of carious tissue with the administration of Papacarie™

Intervention Type: 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 and Bixa orellana extract

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Partial removal with aPDT

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Caries removal with a lowspeed drill

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.

Intervention Type: PROCEDURE

Partial removal of carious tissue with the administration of Papacarie™

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.

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 36870982 (View on PubMed)

Other Identifiers

UrucumCaries

Identifier Type: -

Identifier Source: org_study_id