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Photodynamic in Periodontal Treatment

Sponsor
University of Sulaimani (Other)
Overall Status
Recruiting
CT.gov ID
NCT05162417
Collaborator
(none)
32
Enrollment
1
Location
3
Arms
11.5
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Methylene Blue
  • Other: Toluidine Blue O
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Some Different Photosensitizers in Photodynamic Inactivation of Periodontal Pathogens:A Randomized Clinical Trial
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in probing pocket depth [At the base line and three months]

    millimetre

  2. Change in clinical attachment loss [At the base line and three months]

    millimeter

Secondary Outcome Measures

  1. Change in bleeding on Probing [at base line and 3 month]

    present or absent

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 College of Dentistry, University of Sulaimani Sulaymaniyah Iraq 46001

Sponsors and Collaborators

  • University of Sulaimani

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sarhang Gul, Asst. Prof., University of Sulaimani
ClinicalTrials.gov Identifier:
NCT05162417
Other Study ID Numbers:
  • 55/21
First Posted:
Dec 17, 2021
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by Sarhang Gul, Asst. Prof., University of Sulaimani
Probing Pocket depth
phhotosensitizers
Additional relevant MeSH terms:
Periodontal Diseases
Periodontal Pocket
Tolonium Chloride
Methylene Blue

Study Results

No Results Posted as of Dec 17, 2021