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

Primary Purpose

Teeth, Endodontically-Treated

Status
Completed
Phase
Phase 2
Locations
Serbia
Study Type
Interventional
Intervention
Photodinamic therapy
Diode laser
0.5% Sodium hypochlorite
Sponsored by
Association of Paediatric and Preventive Dentists of Serbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Teeth, Endodontically-Treated focused on measuring photodynamic therapy, diode laser, immature permanent teeth, endodontic therapy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Photodinamic therapy

Diode laser

0.5% Sodium hypochlorite

Arm Description

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.

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).

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).

Outcomes

Primary Outcome Measures

Number of teeth without viable bacteria load in root canal after Photodynamic therapy and Diode laser in endodontic therapy
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

Number of teeth with periapical healing 6 months after treatment, assessed by periapical index (PAI)
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.

Full Information

First Posted
February 11, 2017
Last Updated
May 15, 2018
Sponsor
Association of Paediatric and Preventive Dentists of Serbia
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1. Study Identification

Unique Protocol Identification Number
NCT03074136
Brief Title
Application of Photodynamic Therapy and Diode Laser for Endodontic Therapy of Young Permanent Teeth
Official Title
Application Success of Photodynamic Therapy and Diode Laser During Endodontic Therapy of Young Permanent Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association of Paediatric and Preventive Dentists of Serbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth, Endodontically-Treated
Keywords
photodynamic therapy, diode laser, immature permanent teeth, endodontic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photodinamic therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Diode laser
Arm Type
Experimental
Arm Description
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).
Arm Title
0.5% Sodium hypochlorite
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Photodinamic therapy
Other Intervention Name(s)
PDT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Diode laser
Other Intervention Name(s)
High-power diode laser
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
0.5% Sodium hypochlorite
Other Intervention Name(s)
0.5% NaOCl
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of teeth without viable bacteria load in root canal after Photodynamic therapy and Diode laser in endodontic therapy
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of teeth with periapical healing 6 months after treatment, assessed by periapical index (PAI)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Faculty of Dental Medicine
City
Belgrade
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Application of Photodynamic Therapy and Diode Laser for Endodontic Therapy of Young Permanent Teeth

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