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Application of Photodynamic Therapy and Diode Laser for Endodontic Therapy of Young Permanent Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074136
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dejan Markovic, Association of Paediatric and Preventive Dentists of Serbia

Brief Summary:
The pulp necrosis of permanent immature teeth implies the interruption of the root formation and apical closure. Diode lasers have been used in many areas of dentistry, with tendency of good results in canal and dentine disinfection. The bactericidal effect of high-power lasers is based on dose dependent heat generation. Its antimicrobial effectiveness against diverse microorganisms has already been demonstrated. Photodynamic therapy (PDT) is a two-step therapeutic approach starting with the application of a photosensitizing agent and followed by irradiation with light energy that is spectrally matched to activate the drug. The balance between disinfection and the creation of an intracanal microenvironment conducive for the proliferation of stem cells requires further investigation. Aims of study are to compare the time required to obtain the clinical healing and the disappearance of clinical symptoms, and absence of periapical radiolucency, by using PDT and diode laser, with standard disinfection alone; to assess specificity of microbial load in permanent immature teeth, and root canal disinfection ability of PDT and diode laser, in compare with standard disinfection alone.

Condition or disease Intervention/treatment Phase
Teeth, Endodontically-Treated Device: Photodinamic therapy Device: Diode laser Drug: 0.5% Sodium hypochlorite Phase 2

Detailed Description:

Background and Significance The pulp necrosis of permanent immature teeth implies the interruption of the root formation and apical closure. It is then necessary to implement a therapy to induce a calcified barrier at the apical end of the root. The endodontic management of permanent immature teeth is fraught with challenges. Although treatment modalities for vital pulp therapy in these teeth provide long-term favorable outcome, the outcomes from the treatment of pulp necrosis and apical periodontitis are significantly less predictable. Key role of microorganisms in the causing and development of pulpal and periapical diseases have been demonstrated, and their presence in the canal at the time of definitive filling has negative effect on success of the therapy. However, the specificity of microbial load of immature permanent teeth is not completely investigated, nor the influence of the disinfection protocols on treatment success.

Available procedures rely heavily on root canal chemical disinfection of the root canal system, with minimal mechanical instrumentation. Sodium hypochlorite (NaOCl) in different concentrations is the most accepted solution for disinfection of root canal in endodontic. Despite common usage, impossibility of NaOCl to completely disinfect root canal has been noticed. Traditionally, irrigants and medicaments have been chosen for their maximum antimicrobial effect without consideration for their effects on stem cells and the dentinal microenvironment. The balance between disinfection and the creation of an intracanal microenvironment conducive for the proliferation of stem cells requires further investigation. This requires the interpretation of preclinical studies, and this level of evidence should be increased by randomized controlled clinical studies.

Diode lasers have been used in many areas of dentistry, with tendency of good results in canal and dentine disinfection. The bactericidal effect of high-power lasers is based on dose dependent heat generation. Its antimicrobial effectiveness against diverse microorganisms has already been demonstrated.

Photodynamic therapy (PDT) is a two-step therapeutic approach starting with the application of a photosensitizing agent and followed by irradiation with light energy that is spectrally matched to activate the drug. Because its high antibacterial potential, usage of photodynamic therapy as advance to standard protocol in root canal disinfection have been suggested. Studies showed positive effect of photodynamic therapy in the reduction of microbial load in root canal treatment. When a photoactive compound is applied in the root canal system, it is taken up by residual bacteria in the main canals, isthmuses, lateral canals and dentinal tubules. It is also possible that this compound may escape into the periapical tissues. During PDT, light will excite the drug in bacteria within the root canal, but could also potentially affect the apical stem cells that have taken up the drug. Therefore, it is important to determine the therapeutic window whereby host cells are left intact.

Several studies showed wide-ranging spectra of desirable effects of low level power laser (LLLT) on biological tissue. It has been reported to increase cell functional activity, induce cell proliferation, lowers inflammation, releasing of endorphins, thus having analgetic effect. Furthermore, it has been shown that irradiation with a LLLT following photosensitization with phenothiazine chloride had no negative effect on the growth and differentiation of human osteoblastic cells, and did not counteract the biostimulatory effect induced by LLLT. There were no statistically significant differences in the growth and differentiation behavior between the two study groups. Further investigations of PDT on dental stem cells are needed to determine possible biostimulative effect on proliferation and differentiation, and thereby contribute to root development of non-vital permanent immature teeth. Prolonged treatment of young permanent teeth increases possibility of treatment failure. Involvement of a method that could help healing process is desirable.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Application Success of Photodynamic Therapy and Diode Laser During Endodontic Therapy of Young Permanent Teeth
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Photodinamic therapy
Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degree Celsius). After that, HELBO treatment (Helbo Photodynamic System, Bredent, Senden, Germany) will be applied.
Device: Photodinamic therapy
Dentin sealant (HELBO® Endo Seal, Bredent, Senden, Germany) will be applied over the crown area and light cured. The root canals will be filled with the phenothiazine chloride (HELBO® Endo Blue, Bredent, Senden, Germany), agitated with a size 15K-file and left in the canal for 2 min. After this time, the root canals will be rinsed with distilled water to remove the excess of the photosensitizer, dried with paper points. The disposable 450 µm fiberoptic tip (3D HELBO® Endo Probe, Bredent, Senden, Germany) will be placed in the apical portion of the root canal at the point where resistance to the fiber will be felt, and root canal will be irradiated with HELBO® TheraLite Laser (λ = 660 nm, power = 100 mW) for 60 s (total energy, 6 J) in a continuous wave mode.
Other Name: PDT

Drug: 0.5% Sodium hypochlorite
Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degrees Celsius).
Other Name: 0.5% NaOCl

Experimental: Diode laser
Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degree Celsius). After that high power diode laser therapy will be applied by using Epic diode laser (Biolase® Technology, Inc., San Clemente, CA, USA).
Device: Diode laser
High-power diode laser therapy will be applied by using Epic diode laser (Biolase® Technology, Inc., San Clemente, CA, USA) with settings determined in laboratory researches (λ = 940 nm, maximal power 10W).
Other Name: High-power diode laser

Drug: 0.5% Sodium hypochlorite
Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degrees Celsius).
Other Name: 0.5% NaOCl

Experimental: 0.5% Sodium hypochlorite
Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degree Celsius).
Drug: 0.5% Sodium hypochlorite
Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degrees Celsius).
Other Name: 0.5% NaOCl




Primary Outcome Measures :
  1. Number of teeth without viable bacteria load in root canal after Photodynamic therapy and Diode laser in endodontic therapy [ Time Frame: 6 months ]
    Number of teeth without viable bacteria load after treatment in all experimental groups, will be determined. Microbiological samples from the root canals will be collected immediately after the accessing the canal, following endodontic treatment, and after the laser procedure in adequate groups (Photodynamic therapy or Diode laser). Samples from the root canals will be cultivated in conditions suitable for growth of anaerobes and facultative anaerobes.


Secondary Outcome Measures :
  1. Number of teeth with periapical healing 6 months after treatment, assessed by periapical index (PAI) [ Time Frame: 6 months ]
    Number of teeth with periapical healing 6 months after treatment, will be determined by PAI score index, in all experimental groups. Teeth will be categorized in five groups depending of PAI score: (1) normal periapical structure; (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; and (5) severe periodontitis with exacerbating features.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • a non-vital permanent immature single rooted tooth
  • primary endodontic infection
  • 6 - 18 years old
  • written informed consent obtained from each parent and child

Exclusion criteria

  • uncontrolled diabetes mellitus,
  • immunosuppression,
  • severe asthma
  • usage of antibiotics, anti-inflammatory, corticosteroid, or immunosuppressive therapy during the last 6 months
  • need for antibiotics at current endodontic therapy
  • need for antibiotics in prophylaxis of systematic disease before endodontic therapy
  • periodontal diseases
  • impossible adequate isolation of the tooth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074136


Locations
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Serbia
Faculty of Dental Medicine
Belgrade, Serbia
Sponsors and Collaborators
Association of Paediatric and Preventive Dentists of Serbia

Publications:

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Responsible Party: Dejan Markovic, Professor, Association of Paediatric and Preventive Dentists of Serbia
ClinicalTrials.gov Identifier: NCT03074136    
Other Study ID Numbers: 36/8
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dejan Markovic, Association of Paediatric and Preventive Dentists of Serbia:
photodynamic therapy
diode laser
immature permanent teeth
endodontic therapy
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents