Active Oxygen Releasing Gel With Photodynamic Therapy in Treating Stage III Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Scaling and root planing, topical active oxygen-releasing gel, and photodynamic therapy using diode laser, Scaling and root planing and topical application of active oxygen-releasing gel, Scaling and root planing.
- Who it may be relevant to
- Registry conditions: Stage III Periodontitis. Basic parameters: 30 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Active Oxygen Releasing Gel Combined With Photodynamic Therapy in The Treatment of Stage III Periodontitis (A Randomized Controlled Clinical Trial)
Overview
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.
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 - 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.
Primary outcome measures
- Modified Gingival Index (MGI) score [Time frame: Before enrollment, and one and three months after enrollment]
- Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe [Time frame: Before enrollment, and one and three months after enrollment]
- Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe [Time frame: Before enrollment, and one and three months after enrollment]
- Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe [Time frame: Before enrollment, and one and three months after enrollment]
Secondary outcome measures (1)
- Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR) [Time frame: Before enrollment and one month after enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Alexandria University — Alexandria
Identifiers
NCT: NCT07368699 · 1016-12/2024