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NCT Number: NCT07368699

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

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.

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Key information

Conditions

Stage III Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Bab Sharq, 21578, Egypt

Location status: Recruiting

Location contact

Faculty of Dentistry, Alexandria University

CONTACT

[email protected]

+2034868066

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

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

Procedure

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.

Scaling and Root Planing

Procedure

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

Primary outcomes

  1. Modified Gingival Index (MGI) score

    Time frame: Before enrollment, and one and three months after enrollment

    non-invasive, visual clinical tool (0-4 scale)focuses on color, texture, and contour changes across facial, lingual, mesial, and distal surfaces of tooth ,modified gingival Scoring Criteria for MGI (0-4) higher scores indicate more severe gingival inflammation higher a worse clinical outcome.

    0: Absence of inflammation (normal gingiva).

    • Mild inflammation - slight change in color/texture in part of the marginal or papillary gingiva.
    • Mild inflammation - slight change in color/texture in the entire marginal or papillary gingiva.
    • Moderate inflammation - bright surface, erythema, edema, and/or hypertrophy of the marginal or papillary gingiva.
    • Severe inflammation - severe erythema, edema, and/or marg

  2. Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe

    Time frame: Before enrollment, and one and three months after enrollment

    a clinical parameter measured by inserting a periodontal probe to the base of a gingival pocket.The probe is inserted parallel to the root surface and "walked" around the gingival sulcus, with bleeding assessed 30-60 seconds after probing.recorded as a percentage of positive bleeding sites out of the total sites probed (6 sites per tooth). A higher percentage of bleeding sites indicates increased gingival inflammation and a worse outcome.

  3. Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe

    Time frame: Before enrollment, and one and three months after enrollment

    measured in millimeters using Williams calibrated probe from the cemento-enamel junction to the bottom of the pocket .This measure reflects the extent of periodontal tissue destruction. Higher values in millimeters indicate greater attachment loss and a worse clinical condition.

  4. Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe

    Time frame: Before enrollment, and one and three months after enrollment

    Clinical measurement of the distance in millimeter from the gingival margin to the base of the periodontal pocket using Williams calibrated probe.Deeper pockets indicate more severe periodontal disease. Higher values represent a worse outcome.

Secondary outcomes

  1. Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR)

    Time frame: Before enrollment and one month after enrollment

    Sub-gingival dental plaque biofilm (before the intervention and one month after the intervention) will be collected using size 30 paper point after ensuring good isolation of the operating field. quantitative real time PCR will be performed using universal bacterial 16SrRNA gene primers and species-specific primers targeting the 16S rRNA genes of Treponema denticola (Td), and Porphyromonas gingivalis (Pg), to estimate the relative abundance of Td and Pg among total oral microbiota before and after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Aliaa Gamaleldin Aboulela, PhD

CONTACT

+20 10 02104138

Aya Abdelmawla, BDS

CONTACT

[email protected]

+201128192575

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of Active Oxygen Releasing Gel Combined With Photodynamic Therapy in The Treatment of Stage III Periodontitis (A Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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