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

NCT03074136 | Completed Phase 2 DMC

• 1 other identifier: 36/8
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Teeth, Endodontically-Treated

Keywords

photodynamic therapy; diode laser; immature permanent teeth; endodontic therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (3)

Photodinamic therapy

EXPERIMENTAL

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; Drug: 0.5% Sodium hypochlorite

Diode laser

EXPERIMENTAL

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; Drug: 0.5% Sodium hypochlorite

0.5% Sodium hypochlorite

EXPERIMENTAL

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

Interventions

Photodinamic therapy 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.

Also known as: PDT

Photodinamic therapy

Diode laser 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).

Also known as: High-power diode laser

Diode laser

0.5% Sodium hypochlorite 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).

Also known as: 0.5% NaOCl

0.5% Sodium hypochlorite; Diode laser; Photodinamic therapy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association of Paediatric and Preventive Dentists of Serbia: lead

Study Sites (1)

Faculty of Dental Medicine

Belgrade, Serbia

Location

Related Publications (13)

• 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.

  PMID: 24698694 BACKGROUND

• 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.

  PMID: 18928835 BACKGROUND

• 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.

  PMID: 12877261 BACKGROUND

• 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.

  PMID: 16306819 BACKGROUND

• 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.

  PMID: 12705027 BACKGROUND

• 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.

  PMID: 15117481 BACKGROUND

• 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.

  PMID: 16982278 BACKGROUND

• 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.

  PMID: 24935531 BACKGROUND

• 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.

  PMID: 19840649 BACKGROUND

• 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.

  PMID: 21614480 BACKGROUND

• 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.

  PMID: 21473835 BACKGROUND

• 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.

  PMID: 19196108 BACKGROUND

• 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.

  PMID: 25461966 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Lasers, Semiconductor; Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: March 8, 2017
• Study Start: February 10, 2017
• Primary Completion: December 15, 2017
• Study Completion: May 15, 2018
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)