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

NCT07368699 | Recruiting

• 1 other identifier: 1016-12/2024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Active oxygen releasing gel; Photodynamic therapy; Periodontitis; Scaling and Root Planing,

Outcome Measures

Primary Outcomes (4)

• Modified Gingival Index (MGI) score

  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). 1. Mild inflammation - slight change in color/texture in part of the marginal or papillary gingiva. 2. Mild inflammation - slight change in color/texture in the entire marginal or papillary gingiva. 3. Moderate inflammation - bright surface, erythema, edema, and/or hypertrophy of the marginal or papillary gingiva. 4. Severe inflammation - severe erythema, edema, and/or marg

  Before enrollment, and one and three months after enrollment

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

  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.

  Before enrollment, and one and three months after enrollment

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

  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.

  Before enrollment, and one and three months after enrollment

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

  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.

  Before enrollment, and one and three months after enrollment

Secondary Outcomes (1)

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

  Before enrollment and one month after enrollment

Study Arms (3)

SRP+Active oxygen gel.

EXPERIMENTAL

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

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

SRP+ Oxygen gel+Laser

EXPERIMENTAL

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."

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

Scaling and root planing alone.

ACTIVE COMPARATOR

Scaling and root planing using ultrasonics and Gracey curettes.

Procedure: Scaling and root planing

Interventions

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.

SRP+ Oxygen gel+Laser; SRP+Active oxygen gel.

Scaling and root planing PROCEDURE

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

SRP+ Oxygen gel+Laser; SRP+Active oxygen gel.; Scaling and root planing alone.

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.

SRP+ Oxygen gel+Laser

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Bab Sharq, 21578, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Mohey eldin Elrashidy, PhD,prof

  Faculty of Dentistry periodontology department Alexandria University,Egypt.

  PRINCIPAL INVESTIGATOR

• Tarek Alsahry, Phd

  Faculty of Dentistry periodontology department Alexandria University,Egypt.

  STUDY DIRECTOR

• Aliaa Gamaleldin Aboulela, PhD

  Microbiology Department ,Medical Research Institute Alexandria University,Egypt

  STUDY DIRECTOR

Central Study Contacts

Aya Abdelmawla, BDS

CONTACT

+201128192575; aia.abdelmoula.2019@gmail.com

Aliaa Gamaleldin Aboulela, PhD

CONTACT

+20 10 02104138

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study is open-label for participants and clinicians due to the nature of the interventions. However, to ensure objectivity, the trial statistician and the microbiologist performing the laboratory analysis will remain masked to treatment assignment (blinded) until the final data analysis is complete. Samples sent to the microbiology lab will be coded with unique identification numbers to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontology resident at periodontology department Alexandria University,Egypt

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 27, 2026
• Study Start: January 26, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)