Active Oxygen Releasing Gel With Photodynamic Therapy in Treating Stage III Periodontitis

Alexandria University

Status: Enrolling

Conditions: Stage III Periodontitis

Treatments: Procedure: Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser; Procedure: Scaling and root planing; Procedure: Scaling and root planing and topical application of active oxygen-releasing gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07368699

1016-12/2024

Details and patient eligibility

About

Periodontitis is a serious gum disease that can damage the tissues supporting the teeth. The standard treatment is scaling and root planing of the teeth and roots. However, in some patients, this treatment alone may not fully control inflammation and harmful bacteria.

This study aims to evaluate whether adding an active oxygen-releasing gel, with or without photodynamic therapy, improves treatment outcomes in patients with stage III periodontitis. The oxygen-releasing gel is applied to the gums and releases oxygen, which may help reduce harmful bacteria. Photodynamic therapy uses a light source together with a special dye to target and destroy bacteria and improve gingival health.

In this randomized clinical trial, 42 patients with stage III periodontitis will be divided into three groups. One group will receive standard scaling and root planing (SRP) plus the oxygen-releasing gel. A second group will receive standard scaling and root planing (SRP)plus the gel and photodynamic therapy. The third group will receive standard scaling and root planing(SRP) only.

Gum health will be evaluated by measuring gingival index, bleeding index, pocket depth, and supra crestal tissue attachment level at the start of the study and after one and three months. Microbiological samples from periodontal pockets will also be used to assess levels using quantitative Polymerase Chain Reaction (qPCR) for relative abundance of Treponema denticola and Porphyromonas gingivalis bacteria related to periodontal disease.

Enrollment: 42 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with periodontal diagnosis of stage III periodontitis
• Patients with residual periodontal pocket depth ≥4 mm ,CAL≥ 5mm with bone loss extending to middle third of root and beyond in radiography
• Bleeding on probing at least four sites at base-line
• Patients who didn't receive periodontal treatment for a minimum of 3 months prior to the examination.
• Patients of both sexes aged ≥30 and ≤70 years

Exclusion criteria

• Smokers or those with any other harmful habits such as pipe or vape smoking
• Patients with any systemic condition that will possibly affect the outcome of periodontal therapy i.e. (diabetic patients)
• Patients who have received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months
• Pregnant or lactating women
• Patients with parafunctional habits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

SRP+Active oxygen gel.

Experimental group

Description:

Scaling and root planing(SRP)followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minute

Treatment:

Procedure: Scaling and root planing and topical application of active oxygen-releasing gel

Procedure: Scaling and root planing

SRP+ Oxygen gel+Laser

Experimental group

Description:

Scaling and root planing (SRP) will be performed in a single session, followed by the topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes. Subsequently, antimicrobial Photodynamic Therapy (aPDT) will be applied using a diode laser (635 nm) with tolonium chloride as a photosensitizer. The laser irradiation will be performed at an energy density of 6 J/cm2 for 30 seconds per site."

Treatment:

Procedure: Scaling and root planing and topical application of active oxygen-releasing gel

Procedure: Scaling and root planing

Procedure: Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser

Scaling and root planing alone.

Active Comparator group

Description:

Scaling and root planing using ultrasonics and Gracey curettes.

Treatment:

Procedure: Scaling and root planing