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

NCT ID: NCT03074136

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2018-05-15

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.

Conditions

Teeth, Endodontically-Treated

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Photodinamic therapy

Intervention Type: DEVICE

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.

0.5% Sodium hypochlorite

Intervention Type: DRUG

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).

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).

Group Type: EXPERIMENTAL

Diode laser

Intervention Type: DEVICE

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).

0.5% Sodium hypochlorite

Intervention Type: DRUG

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).

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).

Group Type: EXPERIMENTAL

0.5% Sodium hypochlorite

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DEVICE

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).

Intervention Type: DRUG

Other Intervention Names

PDT; High-power diode laser; 0.5% NaOCl

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Association of Paediatric and Preventive Dentists of Serbia

OTHER

Sponsor Role: lead

Responsible Party

Dejan Markovic

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dental Medicine

Belgrade, , Serbia

Countries

Serbia

References

Diogenes AR, Ruparel NB, Teixeira FB, Hargreaves KM. Translational science in disinfection for regenerative endodontics. J Endod. 2014 Apr;40(4 Suppl):S52-7. doi: 10.1016/j.joen.2014.01.015.

Reference Type: BACKGROUND

PMID: 24698694 (View on PubMed)

Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17.

Reference Type: BACKGROUND

PMID: 18928835 (View on PubMed)

Shabahang S, Pouresmail M, Torabinejad M. In vitro antimicrobial efficacy of MTAD and sodium hypochlorite. J Endod. 2003 Jul;29(7):450-2. doi: 10.1097/00004770-200307000-00006.

Reference Type: BACKGROUND

PMID: 12877261 (View on PubMed)

Waltimo T, Trope M, Haapasalo M, Orstavik D. Clinical efficacy of treatment procedures in endodontic infection control and one year follow-up of periapical healing. J Endod. 2005 Dec;31(12):863-6. doi: 10.1097/01.don.0000164856.27920.85.

Reference Type: BACKGROUND

PMID: 16306819 (View on PubMed)

Pearson GJ, Schuckert KH. The role of lasers in dentistry: present and future. Dent Update. 2003 Mar;30(2):70-4, 76. doi: 10.12968/denu.2003.30.2.70.

Reference Type: BACKGROUND

PMID: 12705027 (View on PubMed)

Gutknecht N, Franzen R, Schippers M, Lampert F. Bactericidal effect of a 980-nm diode laser in the root canal wall dentin of bovine teeth. J Clin Laser Med Surg. 2004 Feb;22(1):9-13. doi: 10.1089/104454704773660912.

Reference Type: BACKGROUND

PMID: 15117481 (View on PubMed)

Soukos NS, Chen PS, Morris JT, Ruggiero K, Abernethy AD, Som S, Foschi F, Doucette S, Bammann LL, Fontana CR, Doukas AG, Stashenko PP. Photodynamic therapy for endodontic disinfection. J Endod. 2006 Oct;32(10):979-84. doi: 10.1016/j.joen.2006.04.007. Epub 2006 Jul 13.

Reference Type: BACKGROUND

PMID: 16982278 (View on PubMed)

Chrepa V, Kotsakis GA, Pagonis TC, Hargreaves KM. The effect of photodynamic therapy in root canal disinfection: a systematic review. J Endod. 2014 Jul;40(7):891-8. doi: 10.1016/j.joen.2014.03.005. Epub 2014 May 2.

Reference Type: BACKGROUND

PMID: 24935531 (View on PubMed)

Xu Y, Young MJ, Battaglino RA, Morse LR, Fontana CR, Pagonis TC, Kent R, Soukos NS. Endodontic antimicrobial photodynamic therapy: safety assessment in mammalian cell cultures. J Endod. 2009 Nov;35(11):1567-72. doi: 10.1016/j.joen.2009.08.002. Epub 2009 Sep 20.

Reference Type: BACKGROUND

PMID: 19840649 (View on PubMed)

Toomarian L, Fekrazad R, Tadayon N, Ramezani J, Tuner J. Stimulatory effect of low-level laser therapy on root development of rat molars: a preliminary study. Lasers Med Sci. 2012 May;27(3):537-42. doi: 10.1007/s10103-011-0935-9. Epub 2011 May 26.

Reference Type: BACKGROUND

PMID: 21614480 (View on PubMed)

Martens LC. Laser physics and a review of laser applications in dentistry for children. Eur Arch Paediatr Dent. 2011 Apr;12(2):61-7. doi: 10.1007/BF03262781.

Reference Type: BACKGROUND

PMID: 21473835 (View on PubMed)

Stein E, Koehn J, Sutter W, Schmidl C, Lezaic V, Wendtlandt G, Watzinger F, Turhani D. Phenothiazine chloride and soft laser light have a biostimulatory effect on human osteoblastic cells. Photomed Laser Surg. 2009 Feb;27(1):71-7. doi: 10.1089/pho.2008.2265.

Reference Type: BACKGROUND

PMID: 19196108 (View on PubMed)

Juric IB, Plecko V, Panduric DG, Anic I. The antimicrobial effectiveness of photodynamic therapy used as an addition to the conventional endodontic re-treatment: a clinical study. Photodiagnosis Photodyn Ther. 2014 Dec;11(4):549-55. doi: 10.1016/j.pdpdt.2014.10.004. Epub 2014 Oct 24.

Reference Type: BACKGROUND

PMID: 25461966 (View on PubMed)

Other Identifiers

36/8

Identifier Type: -

Identifier Source: org_study_id