Periodontal Diseases Clinical Trial
Official title:
Efficacy of Some Different Photosensitizers in Photodynamic Inactivation of Periodontal Pathogens:A Randomized Clinical Trial
NCT number | NCT05162417 |
Other study ID # | 55/21 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 15, 2021 |
Est. completion date | April 1, 2023 |
Verified date | November 2023 |
Source | University of Sulaimani |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 18 |
Est. completion date | April 1, 2023 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Iraq | College of Dentistry, University of Sulaimani | Sulaymaniyah |
Lead Sponsor | Collaborator |
---|---|
University of Sulaimani |
Iraq,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38. — View Citation
Larsen T, Fiehn NE. Dental biofilm infections - an update. APMIS. 2017 Apr;125(4):376-384. doi: 10.1111/apm.12688. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in probing pocket depth | millimetre | At the base line and three months | |
Primary | Change in clinical attachment loss | millimeter | At the base line and three months | |
Secondary | Change in bleeding on Probing | present or absent | at base line and 3 month |
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