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

NCT06305533 | Recruiting DMC

• 1 other identifier: 854623
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bleeding on probing (BOP)

  over a period of 3 months.

• Plaque index (PI)

  over a period of 3 months.

• Clinical attachment loss (CAL)

  over a period of 3 months.

• Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum

  over a period of 3 months.

Study Arms (3)

Control

OTHER

Root surface debridement only

Procedure: Root surface debridement

Test group 1 (Biolase group)

ACTIVE COMPARATOR

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.

Device: LASER disinfection; Procedure: Root surface debridement

Test group 2 (Quicklase group)

ACTIVE COMPARATOR

Root surface debridement and photodynamic therapy using a Indocyanine green photosensitizer activated with diode laser (Quicklase)

Device: Photodynamic therapy; Procedure: Root surface debridement

Interventions

LASER disinfection DEVICE

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.

Test group 1 (Biolase group)

Photodynamic therapy DEVICE

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

Test group 2 (Quicklase group)

Root surface debridement PROCEDURE

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

Control; Test group 1 (Biolase group); Test group 2 (Quicklase group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Central Study Contacts

Zahraa Talib, B.D.S

CONTACT

009647724342248; zahraa.abd2205@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sites will randomly be assigned to test or control groups according to a computer-generated list. Allocation concealment will be assured by opaque, sealed envelopes prepared and sequentially numbered by a person not otherwise involved in the study. The person responsible for delivering treatment will be aware about allocation of the groups, while the assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: This study is 3 arm, split-mouth, double blinded, randomized clinical trial. The first group will receive RSD only, the second group will be treated with RSD + aPDT with ICG as a PS, and the last group will receive RSD + Laser disinfection.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

IR (1)