Photodynamic in Periodontal Treatment

NCT ID: NCT05162417

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-04-01

Brief Summary

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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)

Detailed Description

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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)

Conditions

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Periodontal Diseases Periodontal Pocket

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

patient in this arm will receive scaling and root planning treatment only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Test group (toluidine Blue O)

patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.

Group Type EXPERIMENTAL

Toluidine Blue O

Intervention Type OTHER

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.

Methylene blue

Patients will receive Methylene blue as adjunctive to scaling and root planning.

Group Type EXPERIMENTAL

Methylene Blue

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sulaimani

OTHER

Sponsor Role lead

Responsible Party

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Sarhang Gul

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarhang S. Gul, PhD

Role: PRINCIPAL_INVESTIGATOR

College of Dentistry, University of Sulaimani

Locations

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College of Dentistry, University of Sulaimani

Sulaymaniyah, , Iraq

Site Status

Countries

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Iraq

References

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

Reference Type BACKGROUND
PMID: 28407420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24320956 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 28805207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34576863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33197289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29151775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22057503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29226063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30873451 (View on PubMed)

Other Identifiers

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55/21

Identifier Type: -

Identifier Source: org_study_id