Photodynamic in Periodontal Treatment

Not Applicable

Completed

• Conditions: Periodontal Diseases; Periodontal Pocket
• Interventions: Other: Toluidine Blue O; Other: Methylene Blue

• Registration Number: NCT05162417
• Lead Sponsor: University of Sulaimani

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)

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-17
• Primary Completion: 2022-11-01
• Study Completion: 2023-04-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group (toluidine Blue O)	Toluidine Blue O	patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.
Methylene blue	Methylene Blue	Patients will receive Methylene blue as adjunctive to scaling and root planning.

Primary Outcome Measures

Name	Time	Method
Change in clinical attachment loss	At the base line and three months	millimeter
Change in probing pocket depth	At the base line and three months	millimetre

Secondary Outcome Measures

Name	Time	Method
Change in bleeding on Probing	at base line and 3 month	present or absent

Trial Locations

Locations (1)

College of Dentistry, University of Sulaimani; 🇮🇶 Sulaymaniyah, Iraq