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

Summary

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.

Conditions

• Stage III Periodontitis

Interventions

PROCEDURE

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

14 stage III periodontitis patients will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes then irrigating the targeted pocket using tolonium chloride will be stopped once the tolonium chloride solution will be observed at the free gingival margin of the pocket. After 60 seconds, irradiation inside the periodontal pocket with diode laser (635nm) for 200 mW, 30 seconds, energy density of 6 J/cm2, tip diameter of 400 µm, using continuous modes of irradiation, the laser fiber tip will be positioned parallel to the long axis of the tooth, move in a steady vertical inward and outward motion to ensure that the entire pocket will be adequately covered.

PROCEDURE

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

14 patients with stage III periodontitis will undergo scaling and root planing in a single session followed by topical application of active oxygen-releasing gel (0.4 mL) for 3 minutes.

PROCEDURE

Scaling and root planing

14 patients will undergo scaling and root planing(SRP) using ultrasonics and Gracey curettes.

Sponsors & Collaborators

• Alexandria University

  lead OTHER

Principal Investigators

• Mohey eldin Elrashidy, PhD,prof · Faculty of Dentistry periodontology department Alexandria University,Egypt.

• Tarek Alsahry, Phd · Faculty of Dentistry periodontology department Alexandria University,Egypt.

• Aliaa Gamaleldin Aboulela, PhD · Microbiology Department ,Medical Research Institute Alexandria University,Egypt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-26

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Egypt

Study Locations