Stage III Periodontitis
Conditions
Keywords
Active oxygen releasing gel, Photodynamic therapy, Periodontitis, Scaling and Root Planing,
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.
Interventions
PROCEDUREScaling 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.
PROCEDUREScaling 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.
PROCEDUREScaling and root planing
14 patients will undergo scaling and root planing(SRP) using ultrasonics and Gracey curettes.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Gingival Index (MGI) score | 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). 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 |
| Percentage of sites with Bleeding on Probing (BOP) assessed by a periodontal probe | 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. |
| Measurement of Clinical Attachment Level (CAL) using a Williams calibrated periodontal probe | 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. |
| Probing Pocket Depth (PPD) in millimeters measured by Williams periodontal probe | 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
| Measure | Time frame | Description |
|---|---|---|
| Relative abundance of Treponema denticola and Porphyromonas gingivalis using quantitative Polymerase Chain Reaction (qPCR) | 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 |
Countries
Egypt
Contacts
CONTACTAya Abdelmawla, BDS
CONTACTAliaa Gamaleldin Aboulela, PhD
PRINCIPAL_INVESTIGATORMohey eldin Elrashidy, PhD,prof
Faculty of Dentistry periodontology department Alexandria University,Egypt.
STUDY_DIRECTORTarek Alsahry, Phd
Faculty of Dentistry periodontology department Alexandria University,Egypt.
STUDY_DIRECTORAliaa Gamaleldin Aboulela, PhD
Microbiology Department ,Medical Research Institute Alexandria University,Egypt
Outcome results
None listed