Diode Laser 635 nm and 810 nm Photodynamic Therapy as Adjuncts to Non-Surgical Periodontal Treatment

ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDamascus University

About this trial

This study aims to evaluate and compare the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) using toluidine blue O (TBO) activated by two different diode laser wavelengths as an adjunct to non-surgical periodontal treatment in patients with Stage II and Stage III periodontitis. Participants will be randomly allocated to three treatment groups: non-surgical periodontal treatment combined with aPDT using a 635 nm diode laser, non-surgical periodontal treatment combined with aPDT using an 810 nm diode laser, and non-surgical periodontal treatment alone. The treatment outcomes will be evaluated based on changes in the following clinical periodontal parameters: Plaque Index (PI), Bleeding on Probing (BOP), Relative Attachment Level (RAL), Probing Depth (PD), and Gingival Recession (GR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older (up to 65 years)

Participants diagnosed with Periodontitis Stage II-III according to the 2017 classification

Presence of at least 3 periodontal sites with a probing pocket depth (PPD) of ≥ 5 mm.

No periodontal treatment during the previous 6 months

Disqualifiers

Presence of systemic diseases or medical conditions that may affect periodontal status, wound healing, or the response to periodontal treatment.

Use of systemic antibiotics or other medications that may significantly affect periodontal treatment outcomes within the last 6 months.

Previous periodontal treatment within the last 6 months.

Known allergy or hypersensitivity to toluidine blue O or any material used in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment

    Other intervention

    Participants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by a 635 nm diode laser. The same treatment procedure will be repeated after two weeks.

  • 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal Treatment

    Other intervention

    Participants assigned to this group will undergo non-surgical periodontal treatment with subgingival mechanical instrumentation using slim ultrasonic scaler tips. Antimicrobial photodynamic therapy will then be performed using toluidine blue O as the photosensitizing agent, activated by an 810 nm diode laser. The same treatment procedure will be repeated after two weeks.

  • Non-Surgical Periodontal Treatment Alone (Control)

    Procedure/Surgery

    Participants assigned to the control group will receive non-surgical periodontal treatment consisting of subgingival mechanical instrumentation using slim ultrasonic scaler tips. No photodynamic therapy or laser application will be performed.

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: Arm 1: 635 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentExperimental treatment 1 intervention
Group B: Arm 2: 810 nm Diode Laser-Mediated aPDT + Non-Surgical Periodontal TreatmentExperimental treatment 1 intervention
Group C: Arm 3: Non-Surgical Periodontal Treatment Alone (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in probing pocket depth (PPD).

Probing pocket depth will be measured in millimeters from the free gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at standardized sites.

Time frame
Baseline to 3 months after the first treatment session.

Secondary outcomes

1

Change in Relative attachment level (RAL)

Relative attachment level (RAL) will be measured in millimeters from a standardized fixed reference point on a vacuum stent to the base of the periodontal pocket, measured using a UNC-15 periodontal probe.

Time frame
from baseline to 3 months
2

Change in Gingival Recession (GR).

Gingival Recession (GR) will be measured in millimeters from the cementoenamel junction (CEJ) to the most apical point of the gingival margin, using a UNC-15 periodontal probe.

Time frame
At baseline then 1 month and 3 months after the first session.
3

Change in Bleeding on Probing (BOP)

The presence or absence of bleeding following standardized periodontal probing to the base of the periodontal pocket. BOP will be recorded as a dichotomous outcome (present/absent) at the selected periodontal sites, and the percentage of BOP-positive sites will be calculated at baseline and at each follow-up visit.

Time frame
At baseline then 1 month and 3 months after the first session.

Other outcomes

Sponsors and contacts

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