Photodynamic in Periodontal Treatment

November 27, 2023 updated by: Sarhang Gul, University of Sulaimani

Efficacy of Some Different Photosensitizers in Photodynamic Inactivation of Periodontal Pathogens:A Randomized Clinical Trial

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Sulaymaniyah, Iraq, 46001
        • College of Dentistry, University of Sulaimani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Experimental: Methylene blue
Patients will receive Methylene blue as adjunctive to scaling and root planning.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sulaimani

Investigators

  • Principal Investigator: Sarhang S. Gul, PhD, College of Dentistry, University of Sulaimani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon reasonable request following publication by principal investigators

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

The data will be available upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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