Photodynamic in Periodontal Treatment

Overview

Dental biofilm is a primary etiological factor for periodontal diseases.(1) The bacterial biofilm would induce recruitment of leucocytes, neutrophils, and T lymphocytes and the secretion of antibodies, lipopolysaccharides, and chemical inflammatory mediators such as cytokines and chemokines.(2) Thus, periodontal diseases can cause tissue destruction and results in deterioration of clinical parameters measures such as periodontal pockets depth, clinical attachment loss, bleeding on probing, bone destruction, and resulting ultimately in tooth loss.(3)

Full Title of Study: “Efficacy of Some Different Photosensitizers in Photodynamic Inactivation of Periodontal Pathogens:A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 1, 2022

Detailed Description

Mechanical scaling and polishing are the conventional methods in treating periodontal diseases; however, due to difficulties in access to the irregular and furcation areas, it is impossible to be used as a sole means for calculus and bacterial deposit removal.(4) For this reason, adjunctive aids like systemic and local antibiotics are necessary to be administrated However, they have many adverse effects.(5) Another adjunctive aid like antibacterial photodynamic therapy (APDT), has been introduced to periodontology to achieve bacterial eradication, with minimum side effects.(6) APDT involves using visible light with an appropriate wavelength to kill microorganisms with a photosensitizing drug.(7) APDT could be an adjunctive aid to mechanical debridement in eliminating key periodontal pathogens. This therapy was specified as an oxygen-dependent photochemical reaction upon light-mediated activation of photosensitizing materials leading to cytotoxic reactive oxygen species (ROS) generation, predominantly singlet oxygen.(8) The activity of APDT is dependent on the combination of a non-toxic photosensitizer and a specific wavelength of visible light, which is activated and can promote a phototoxic response in the presence of ambient oxygen.(9) APDT is characterized by ROS generation by PSs in response to photo illumination, which later causes cell death.(6)

Interventions

  • Other: Methylene Blue
    • 1mg/ml of Methylene as a solution will be used two times, first immediately after scaling and root planning, second after two weeks of the first treatment.
  • Other: Toluidine Blue O
    • 1mg/ml of Toluidine blue o as a solution will be used two times, first immediately after scaling and root planning, second after two weeks of the first treatment.

Arms, Groups and Cohorts

  • No Intervention: Control group
    • patient in this arm will receive scaling and root planning treatment only.
  • Experimental: Test group (toluidine Blue O)
    • patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.
  • Experimental: Methylene blue
    • Patients will receive Methylene blue as adjunctive to scaling and root planning.

Clinical Trial Outcome Measures

Primary Measures

  • Change in probing pocket depth
    • Time Frame: At the base line and three months
    • millimetre
  • Change in clinical attachment loss
    • Time Frame: At the base line and three months
    • millimeter

Secondary Measures

  • Change in bleeding on Probing
    • Time Frame: at base line and 3 month
    • present or absent

Participating in This Clinical Trial

Inclusion Criteria

  • Each patient should have at least four teeth with a probing depth ≥of 5mm. – Patients with good domestic oral hygiene will be include (documented with a full mouth plaque index of ≤ 30% before starting the clinical trial) Exclusion criteria:

  • Patients receiving periodontal therapy and/or antibiotics within the previous six months – Patients with diseases or medication with an inhibitory or promoting effect on periodontal healing, including anticoagulants, anti-inflammatories. – Pregnant or nursing women – Patients allergic to the test product will be excluded.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Sulaimani
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sarhang Gul, Asst. Prof. – University of Sulaimani
  • Overall Official(s)
    • Sarhang S. Gul, PhD, Principal Investigator, College of Dentistry, University of Sulaimani
  • Overall Contact(s)
    • Sarhang S. Gul, PhD, 7701447723, sarhang.hama@univsul.edu.iq

References

Larsen T, Fiehn NE. Dental biofilm infections – an update. APMIS. 2017 Apr;125(4):376-384. doi: 10.1111/apm.12688.

Cekici A, Kantarci A, Hasturk H, Van Dyke TE. Inflammatory and immune pathways in the pathogenesis of periodontal disease. Periodontol 2000. 2014 Feb;64(1):57-80. doi: 10.1111/prd.12002.

Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.

Shrivastava D, Natoli V, Srivastava KC, Alzoubi IA, Nagy AI, Hamza MO, Al-Johani K, Alam MK, Khurshid Z. Novel Approach to Dental Biofilm Management through Guided Biofilm Therapy (GBT): A Review. Microorganisms. 2021 Sep 16;9(9):1966. doi: 10.3390/microorganisms9091966.

Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

Carrera ET, Dias HB, Corbi SCT, Marcantonio RAC, Bernardi ACA, Bagnato VS, Hamblin MR, Rastelli ANS. The application of antimicrobial photodynamic therapy (aPDT) in dentistry: a critical review. Laser Phys. 2016 Dec;26(12):123001. doi: 10.1088/1054-660X/26/12/123001. Epub 2016 Nov 9.

Kharkwal GB, Sharma SK, Huang YY, Dai T, Hamblin MR. Photodynamic therapy for infections: clinical applications. Lasers Surg Med. 2011 Sep;43(7):755-67. doi: 10.1002/lsm.21080.

Kashef N, Huang YY, Hamblin MR. Advances in antimicrobial photodynamic inactivation at the nanoscale. Nanophotonics. 2017 Aug;6(5):853-879. doi: 10.1515/nanoph-2016-0189. Epub 2017 Aug 1.

Liu Y, Qin R, Zaat SAJ, Breukink E, Heger M. Antibacterial photodynamic therapy: overview of a promising approach to fight antibiotic-resistant bacterial infections. J Clin Transl Res. 2015 Dec 1;1(3):140-167. eCollection 2015 Dec 30.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.