Photodynamic in Periodontal Treatment
Primary Purpose
Periodontal Diseases, Periodontal Pocket
Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Methylene Blue
Toluidine Blue O
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring Probing Pocket depth, phhotosensitizers
Eligibility Criteria
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.
Sites / Locations
- College of Dentistry, University of SulaimaniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
Test group (toluidine Blue O)
Methylene blue
Arm Description
patient in this arm will receive scaling and root planning treatment only.
patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.
Patients will receive Methylene blue as adjunctive to scaling and root planning.
Outcomes
Primary Outcome Measures
Change in probing pocket depth
millimetre
Change in clinical attachment loss
millimeter
Secondary Outcome Measures
Change in bleeding on Probing
present or absent
Full Information
NCT ID
NCT05162417
First Posted
November 29, 2021
Last Updated
December 10, 2021
Sponsor
University of Sulaimani
1. Study Identification
Unique Protocol Identification Number
NCT05162417
Brief Title
Photodynamic in Periodontal Treatment
Official Title
Efficacy of Some Different Photosensitizers in Photodynamic Inactivation of Periodontal Pathogens:A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sulaimani
4. Oversight
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
Data Monitoring Committee
Yes
5. 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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontal Pocket
Keywords
Probing Pocket depth, phhotosensitizers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patient in this arm will receive scaling and root planning treatment only.
Arm Title
Test group (toluidine Blue O)
Arm Type
Experimental
Arm Description
patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.
Arm Title
Methylene blue
Arm Type
Experimental
Arm Description
Patients will receive Methylene blue as adjunctive to scaling and root planning.
Intervention Type
Other
Intervention Name(s)
Methylene Blue
Intervention Description
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
Intervention Name(s)
Toluidine Blue O
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in probing pocket depth
Description
millimetre
Time Frame
At the base line and three months
Title
Change in clinical attachment loss
Description
millimeter
Time Frame
At the base line and three months
Secondary Outcome Measure Information:
Title
Change in bleeding on Probing
Description
present or absent
Time Frame
at base line and 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarhang S. Gul, PhD
Phone
7701447723
Ext
00964
Email
sarhang.hama@univsul.edu.iq
First Name & Middle Initial & Last Name or Official Title & Degree
Kashan K. Najm, BDS
Phone
7706545020
Ext
00964
Email
Kashankamal90@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarhang S. Gul, PhD
Organizational Affiliation
College of Dentistry, University of Sulaimani
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry, University of Sulaimani
City
Sulaymaniyah
ZIP/Postal Code
46001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarhang S. Gul, PhD
Phone
7701447723
Ext
00964
Email
sarhang.hama@univsul.edu.iq
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://sites.google.com/a/univsul.edu.iq/school-of-dentistry/
Citations:
PubMed Identifier
28407420
Citation
Larsen T, Fiehn NE. Dental biofilm infections - an update. APMIS. 2017 Apr;125(4):376-384. doi: 10.1111/apm.12688.
Results Reference
background
PubMed Identifier
24320956
Citation
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.
Results Reference
background
PubMed Identifier
28805207
Citation
Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.
Results Reference
background
PubMed Identifier
34576863
Citation
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.
Results Reference
background
PubMed Identifier
33197289
Citation
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.
Results Reference
background
PubMed Identifier
29151775
Citation
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.
Results Reference
background
PubMed Identifier
22057503
Citation
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.
Results Reference
background
PubMed Identifier
29226063
Citation
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.
Results Reference
background
PubMed Identifier
30873451
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28407420/
Description
pubmed resource
URL
http://pubmed.ncbi.nlm.nih.gov/24320956/
Description
pubmed resource
URL
http://pubmed.ncbi.nlm.nih.gov/28805207/
Description
pubmed resource
URL
https://pubmed.ncbi.nlm.nih.gov/34576863/
Description
pubmed resource
URL
https://pubmed.ncbi.nlm.nih.gov/33197289/
Description
pubmed resource
URL
https://pubmed.ncbi.nlm.nih.gov/29151775/
Description
pubmed resource
URL
https://pubmed.ncbi.nlm.nih.gov/22057503/
Description
pubmed resource
URL
https://pubmed.ncbi.nlm.nih.gov/29226063/
Description
pubmed resource
URL
https://pubmed.ncbi.nlm.nih.gov/30873451/
Description
pubmed resource
Learn more about this trial
Photodynamic in Periodontal Treatment
We'll reach out to this number within 24 hrs