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

Efficacy of Photodynamic Therapy and LASER Disinfection as Adjunct to Nonsurgical Periodontal Therapy for Treatment of Periodontitis: Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Root surface debridement; Device: LASER disinfection; Device: Photodynamic therapy

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zahraa Talib, B.D.S; Phone Number: 009647724342248; Email: zahraa.abd2205@codental.uobaghdad.edu.iq

Study Locations

• Iraq
  • Baghdad, Iraq, 10047
    • Recruiting
    • College of Dentistry, University of Baghdad
    • Contact: Phone Number: +964 14169394; Email: master@codental.uobaghdad.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult subjects (>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. Additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. All patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (Anterior teeth and premolars) with 4-6 mm PPD and positive BOP. Periodontitis cases will be defined by presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.

Exclusion Criteria:

• Patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. Additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Root surface debridement only	Procedure: Root surface debridement; For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.
Active Comparator: Test group 1 (Biolase group); Root surface debridement and laser disinfection, the diode Laser (Bolas) will be used to disinfect the inner layer of the pockets and thus reducing the microbial load.	Procedure: Root surface debridement; For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.; 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.
Active Comparator: Test group 2 (Quicklase group); Root surface debridement and photodynamic therapy using a Indocyanine green photosensitizer activated with diode laser (Quicklase)	Procedure: Root surface debridement; For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Pocket Depth (PPD)	PPD will be measured from the gingival margin to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .	over a period of 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing (BOP)	The BOP will be scored as 0 (absent) and 1 (present) after probing within 30s by quadrant using UNC-15 periodontal probe .	over a period of 3 months.
Plaque index (PI)	Biofilm will be determined using a dichotomous scoring system as presence (1) or absence (0). Disclosing solution will be used to assess agreement on scoring of biofilm.	over a period of 3 months.
Clinical attachment loss (CAL)	CAL will be measured from the cementoenamel junction to the base of the pocket using UNC-15 periodontal probe and the measurements in millimetre .	over a period of 3 months.
Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum	Real time PCR will be used to assess the detection of the following periodontal pathogens in the subgingival biofilm samples: F. nucleatum and F. fastidiosum, according to manufacturer's instructions. Identification of target bacteria through PCR will be executed using species specific primers.	over a period of 3 months.

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 9, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 854623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No