CariesPhase 2NCT05236205

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

A Phase 2 study testing Caries removal with a lowspeed drill, Partial removal of carious tissue with the administration of Papacarie™ and Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%) in people with Caries, run by University of Nove de Julho.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Caries
What is being tested?: Caries removal with a lowspeed drill, Partial removal of carious tissue with the administration of Papacarie™ and Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: No sites listed yet
Study dates: 30 May 2022to 20 Dec 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions - Study Protocol for a Randomized, Controlled Clinical Trial

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
Being tested: Caries removal with a lowspeed drill, Partial removal of carious tissue with the administration of Papacarie™, Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%), Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caries removal with a lowspeed drillProcedure or surgery
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.
Partial removal of carious tissue with the administration of Papacarie™Procedure or surgery
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.
Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)Procedure or surgery
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 of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)Procedure or surgery
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.

Study groups in NCT05236205
Study group	Role	What they receive
Control Group	Experimental	This group will receive the treatment of caries removal with a lowspeed drill (conventional treatment). Receives: Procedure: Caries removal with a lowspeed drill
Papacarie	Experimental	In this group, partial caries removal with Papacarie will be performed. Receives: 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. Receives: 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). Receives: Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and immediately after treatment.

Secondary outcomes (5)

Changes in Radiographic evaluation
Periapical and interproximal radiographs will be taken initially and immediately after the procedure. Subsequently, follow up will be performed at immediately, 1 week, 1, 3, 6, and 12 months for the evaluation of optical density on the radiographs and the visual clinical interpretation of the remaining dentin as well as the evaluation using the radiographic subtraction method. The radiographic images from the different evaluation times will be scanned for the analysis of differences in density. For such, an specific program will be used.
Measured: Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
Evaluation of time required for procedure
The time required for each procedure will be measured using a digital stopwatch (Kenko, Hong Kong) in minutes and seconds from the onset of treatment until the complete removal of the carious tissue. The time will be recorded on a specific chart for analysis.
Measured: During the procedure.
Evaluation of need for local anesthesia during intervention
All interventions will be initiated without the prior administration of local anesthesia. The children will be told that anesthesia could be administered at any time during the intervention. The need for anesthesia, or not, will be recorded.
Measured: During the procedure.
Changes in Clinical Evaluation
The criteria used of the evaluation will be the retention of the restorative material in the cavity and the occurrence of secondary caries. Digital photographs of the restorations will also be taken and serve to complement the clinical and radiographic findings.
0 = present; no defects;
1. = present; small marginal defects measuring less than 0.5mm in depth; no need for repair;
2. = present; small marginal defects measuring 0.5mm to 1mm in depth; need for repair;
3. = present; large marginal defects measuring 1 or more mm in depth; need for repair;
4. = absent; restoration nearly or completely lost; need for treatment;
5. = absent; additional treatment having been performed for some reason;
6. = tooth absent for any reason;
7. = present; surface wear measuring less than 0.5mm in depth; no need for replacement;
8. = present; surface wear greater than 0.5mm in depth; need for replacement;
9. = impossible to diagnose.
Measured: Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
Degree of pain/discomfort of children during procedure
A face scale with different expressions will be used and the child will be asked to point to the expression that most corresponds to his/her degree of pain/discomfort.
Interpretation of face scale:
1. No pain.
2. Mild pain.
3. Moderate pain.
4. A little worse pain.
5. Strong pain.
6. Worst pain.
Measured: During the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202220 Dec 2022

First posted11 Feb 2022
Study start30 May 2022 (estimated)
Primary completion30 Nov 2022 (estimated)
Study completion20 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05236205
Sponsor's protocol ID: UrucumCaries
Status last verified: May 2022
First submitted: 21 Jan 2022
Last updated: 17 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36870982

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions - Study Protocol for a Randomized, Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05236205
Acronym / sponsor ID: UrucumCaries
Conditions: Caries
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 160 participants (estimated)
Lead sponsor: University of Nove de JulhoUniversity, hospital or other
Study start: 30 May 2022 (estimated)
Primary completion: 30 Nov 2022 (estimated)
Study completion: 20 Dec 2022 (estimated)
First posted: 11 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Control Group	Experimental	Procedure: Caries removal with a lowspeed drillThis group will receive the treatment of caries removal with a lowspeed drill (conventional treatment).
Papacarie	Experimental	Procedure: Partial removal of carious tissue with the administration of Papacarie™In this group, partial caries removal with Papacarie will be performed.
Papacarie and Bixa orellana extract	Experimental	Procedure: Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)In this group, partial caries removal with Papacarie and the application of Bixa orellana extract (20%) will be performed.
Partial removal with aPDT	Experimental	Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (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).

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Caries removal with a lowspeed drill1. 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.	Procedure or surgery	Control Group
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.	Procedure or surgery	Papacarie
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.	Procedure or surgery	Papacarie and Bixa orellana extract
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.	Procedure or surgery	Partial removal with aPDT

Primary outcome

Changes in Microbiological Evaluation
Time frame: Baseline and immediately after treatment.
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.

5 secondary outcomes

Changes in Radiographic evaluation
Time frame: Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
Evaluation of time required for procedure
Time frame: During the procedure.
Evaluation of need for local anesthesia during intervention
Time frame: During the procedure.
Changes in Clinical Evaluation
Time frame: Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
Degree of pain/discomfort of children during procedure
Time frame: During the procedure.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Derived from this study: PubMed 36870982Martins 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Microbiological Evaluation (time frame: Baseline and immediately after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.