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Dental CariesNCT02908789

Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment of Deep Carious Lesions in Children

A study testing Antimicrobial photodynamic therapy (aPDT) and Without Antimicrobial phothodynamic therapy in people with Dental Caries, run by Universidade Federal Fluminense at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep carious lesions. This study was approved by the Research Ethics Committee and was conducted on 53 patients between 3 and 12 years. Read more about this study

Who is it for?
Ages 3 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Antimicrobial photodynamic therapy (aPDT) and Without Antimicrobial phothodynamic therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBrazil
Study dates
Mar 2016to Dec 2019
Phase
Interventional
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 3 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patients included in the study should have at least one primary molar or permanent with deep active caries limited occlusal / proximal surfaces involving beyond the inner half of dentin.

Who cannot join

  • Children whose parents refuse to sign the informed consent document
  • Children who do not cooperate with the clinical examination/treatment
  • Children with syndromes or chronic systemic diseases
  • Teeth with painful symptoms consistent with irreversible pulpitis or mobility
  • Periodontal changes
  • Roots with pathological resorption
  • Cases of primary teeth roots in advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Universidade Federal Fluminense

    Nova Friburgo, Rio de Janeiro, 28625650

Other trials in Brazil

About this study

Official title: Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment for Deep Carious Lesions in Children

This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep carious lesions. This study was approved by the Research Ethics Committee and was conducted on 53 patients between 3 and 12 years. Patients included in the study should have at least one primary molar or permanent with deep active caries and limited occlusal/proximal surfaces involving beyond the inner half of dentin. The investigators considered from exclusion criteria children whose parents refuse to sign the informed consent document; children who do not cooperate with the clinical examination/treatment; children with syndromes or chronic systemic diseases; teeth with painful symptoms consistent with irreversible pulpitis or mobility; periodontal changes; roots with pathological resorption; cases of primary teeth roots in an advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning. The treatments were carried out after local anesthesia and isolation of the operative field with a rubber dam. The removal of carious dentin surface demineralized necrotic and not subject to remineralization was held with the drill at low rpm under cooling with sterile saline. The removal of decayed tissue will start with the side walls and later on the pulp wall. After this time the intervention with aPDT using 0.01% methylene blue as photosensitizer will be held. Finally, the cavity is restored with an adhesive and composite resin system. To collect data for the first outcome the dentin samples were collected from 23 participants with the help of spoon sterile dentine in two stages: C1 after digging and C2 after aPDT. The microbiological analyzes will be conducted by counting colony-forming units (CFU / mg of carious dentin), blindly from coded samples. The viability of microorganisms will be evaluated in the following culture media: Brain Heart Infusion agar for the feasibility of total microorganisms; CHROMagar candida to Candida genus; Mitis Salaviarius agar with the addition of bacitracin 0.2 U/mL, sucrose and glucose to Streptococcus mutans; Mitis Salivarius agar to total Streptococcus; Rogosa Agar to Lactobacillus spp. and enterococcosel for Enterococcus genus. The reproducibility of the counting method will be verified between triplicates. Microbiological data will be evaluated with appropriate statistical tests with a level of 5%. For the second outcome, a randomized clinical trial was designed. Primary molars of 30 patients (mean age 6.15 years) with deep caries lesions without signs and symptoms of pulpal involvement were selected. A total of 64 teeth were randomly divided into groups G1 (SCR, 32 teeth) and G2 (SCR + aPDT, 32 teeth) for treatment, restored with composite and evaluated after a week (T0), 6 months (T1), and 12 months (T2) according to the criteria of FDI. Groups were compared using the Rao-Scott chi-squared test and the logistic regression analysis for complex designs to ac- count for multiple observations per subject (alpha = 0.05). All participants answered a questionaire to detect the impact on Oral Health-related quality of life(OHRQoL) before and 3 months after the treatment. Based on this project we prove the clinical efficacy of aPDT using 0.01% methylene blue as an adjunct in reducing microorganisms from the interior of deep carious lesions and we contributed to demonstrate the clinical and radiographic success in a follow-up from 12 months providing additional support aPDT used as an adjunct to SCR on the longevity of composite resin restorations in primary molars. A low laser therapy (aPDT) with SCR did not influence negatively OHRQoL. In the practice of pediatric dentistry, this conservative dental treatment improved the OHRQoL after 3 months of follow up.

Conditions
Dental Caries
Being tested
Antimicrobial photodynamic therapy (aPDT), Without Antimicrobial phothodynamic therapy
Keywords
Photochemotherapy
Medical subject headings
Dental Caries

What participants receive

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

  • Antimicrobial photodynamic therapy (aPDT)Radiation

    Selective caries removal + Antimicrobial photodynamic therapy (aPDT) is an effective low potency laser that involves the activation of a photosensitizer( 0.01% methylene blue ) by a visible light source that creates chemical reactions, producing cytotoxic reactive oxygen species and causing oxidative stress and inactivation of pathogenic microorganisms + tooth restauration

  • Without Antimicrobial phothodynamic therapyOther

    Selective caries removal + tooth restauration

Study groups in NCT02908789
Study groupRoleWhat they receive
Antimicrobial photodynamic therapy (aPDT)Experimental1)Selective caries removal: caries dentin was partially removed with hand excavators (Fava, Pirituba, Brazil). 2)The laser technique: 0.01% methylene blue solution was applied, and a pre-irradiation period of 5 minutes was done with an Indium Gallium Aluminum Phosphorus diode laser (InGaAlP) with a wavelength of 660 nm (visible red), a spot area of 3mm2, and fixed output power of 100 mW (energy of 9 J with 90 seconds). 3) The restorative technique was done as described in comparator group.
Receives: Radiation: Antimicrobial photodynamic therapy (aPDT)
Group without Antimicrobial photodynamic therapy (aPDT)Sham comparator1) Selective caries removal 2) The restorative technique was done by etching with 37% CondacTM phosphoric acid conditioner (FGM) for 15 s in enamel and 7 s in dentin was performed followed by washing for 30 s until the conditioner was completely removed. The excess of dentin moisture was removed with sterile cotton balls, and the enamel was air-dried until it had an opaque appearance. Subsequently, two consecutive layers of Adper Single Bond 2TM (3M ESPE) were applied with a KG Brush (KG Sorensen) on the enamel and dentin for 15 s and subjected to light air blast to promote solvent evaporation. The adhesive was photoactivated for 10 s with a light-emitting diode (LED) unit (BioLuz Plus; BioArt) with an intensity of 460 mW/mm2. The cavity was restored with a Filtek Z250TM composite resin (3M Dental Products) according to the incremental technique. Each increment was photo-activated for 40 s.
Receives: Other: Without Antimicrobial phothodynamic therapy

What is being measured

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

  1. Evaluate Antimicrobial photodynamic therapy (aPDT) on microorganism reduction in deep cavities immediately after dental caries remotion and immediately use aPDT

    Microorganisms reduction count after after manual excavation (control) and immediately after aPDT (experimental) obtained by means counting of colony forming units (CFU / mg of carious dentin), blindly from coded samples from the following viability of microorganisms total microorganisms; Candida genus; Streptococcus mutans; total Streptococcus; Lactobacillus spp. and for Enterococcus genus.After the period of 3, 6, 12 and 24 months of implementation of the treatment, there will be clinical and radiographic examination for treatment success.

    Measured: Microorganisms reduction couting of colony forming units will be evaluated seven days after. The clinical success will be evaluated 3 months, 6 months, 12 months and 24 months.

  2. Evaluation of composite restorations in primary molars subjected to selective caries removal associated with antimicrobial photodynamic therapy

    Antimicrobial photodynamic therapy (aPDT) has been used as an adjunct treatment of deep caries lesions; however, studies on the effects of aPDT on the longevity of restorations are still limited.

    Measured: A total of 64 teeth were randomly divided into groups G1 (SCR, 32 teeth) and G2 (SCR + aPDT, 32 teeth) for treatment, restored with composite, and evaluated after a week (T0), 6 months (T1), and 12 months (T2) according to the criteria of FDI.

Secondary outcomes (1)
  1. Effect of Treatment with Selective Caries Removal Associated to Antimicrobial Photodynamic Therapy on Children's Oral HealthRelated Quality of Life: A Non-Randomized Clinical Study

    How patients perceive impact of diseases is an essential component when characterising different disease impacts, and effects of dental treatments should be perceived by the patients.

    Measured: The impact was assessed before and after conservative treatment of deep caries lesions using the selective caries removal (SCR) associated to a low laser therapy (antimicrobial photodynamic therapy-aPDT) on oral health-related quality of life (OHRQoL).

Timeline

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

  1. First posted21 Sep 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2018
  4. Study completionDec 2019

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02908789
Sponsor's protocol ID
PDTa and dental carie
Status last verified
Nov 2022
First submitted
1 Sep 2016
Last updated
30 Nov 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Antimicrobial photodynamic therapy (aPDT) and Without Antimicrobial phothodynamic therapy in people with Dental Caries, run by Universidade Federal Fluminense at 1 site in Brazil.

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 1 inclusion and 7 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: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate Antimicrobial photodynamic therapy (aPDT) on microorganism reduction in deep cavities immediately after dental caries remotion and immediately use aPDT (time frame: Microorganisms reduction couting of colony forming units will be evaluated seven days after. The clinical success will be evaluated 3 months, 6 months, 12 months and 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Nov 2022.

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