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Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis

NCT06305533 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-03-12

No results posted yet for this study

Summary

The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:

Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.

Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.

All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.

All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.

Conditions

  • Periodontitis

Interventions

DEVICE

LASER disinfection

In test group 1, the diode Laser will be used to disinfect the inner layer of the pockets and thus reducing the microbial load. Diode laser (Biolase, EpicX, BIOLASE, Inc, USA) settings will be as follows: wavelength: 940nm; power: 1W; 300μm uninitiated fibers; continuous radiation mode; and energy level: 80 J/s. The laser fibers then will be inserted into the pockets in such a way that they will be in contact with the soft tissue wall of the pockets and parallel to the root surface and then will be moved to the apical surface through a horizontal sweeping motion (1mm/s) while remaining in contact with the soft tissue wall of the pockets.

DEVICE

Photodynamic therapy

the second test group will receive additional adjunctive aPDT using a ICG photosensitizer activated with diode laser. In details, pockets will be irrigated by a syringe loaded with an ICG photosensitizer solution (Verdye, Diagnostic green, Germany) at a concentration of 5mg/ml. The ICG solution will be allowed to stay in the pockets for 2min, and washing out excess solution from the pockets before laser irradiation. Afterwards, a 300μm bulb optical fibre of the 810nm diode laser unit (QuickLase, United Kingdom) set at 300mw in pulsed mode (100ms ON/100ms OFF) will be inserted along the pocket and activated for 30s with continuous vertical movements from the bottom of the pocket to the gingival margin

PROCEDURE

Root surface debridement

For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-09-30
Completion
2024-10-31

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305533 on ClinicalTrials.gov