Clinical Trial Search

Primary: Number of Participants With Stomatitis Grade ≥ 2 — 2; 83; 1 Participants — p=<0.001

Primary: Palatal Inflammation — 3; 3; 2.5; 2 units on a scale — p=<0.0001

Primary: Maximum Change in Mean Mouth and Throat Soreness (MTS) Score From Baseline Through Weeks of Radiation Therapy Using the MTS Question of the Modified Oral Mucositis Daily…

Primary: Gingival Index (GI) — 1.04; 1.01 units on a scale — p=<0.05

Primary: Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation — 3.176; 3.821 scores in Visual Analogue Scale

Primary: Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy — 15; 9; 10; 12 Participants

Primary: Oral Mucositis Severity - WHO Scale — 3; 3; 0; 0 participants

Primary: Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment — 0.909; 1.035 units on a scale — p=0.168

Primary: Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy — 1.42; 1.36 units on a scale

Primary: Duration of Ulcerative Oral Mucositis — 2.3; 3.2 Days

Primary: Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening — 0; 0; 0; 0 Percentage of Participants

Primary: Number of Participants With Adverse Events (AEs) — 2; 3; 0; 2 participants

Primary: OMI-20 Total Score Change From Baseline to Day 3 — 0.0; 0.0 score on a scale

Primary: Number of Bleeding Sites at Week 12 — 42.02; 67.36 number of bleeding sites — p=<0.0001

Primary: Percentage of Participants With a Response as Assessed by the 273-point Oral Mucositis Rating Scale (OMRS) Who Received Topical Clobetasol 0.05% Oral Rinse for Oral…

Primary: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. — 0.6; 0.15 units on a scale

Primary: Incidence of Oral Mucositis — 66; 10; 64 percentage of participants

Primary: Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) — 28; 46 participants — p=0.09

Primary: Bleeding on Probing — 53.8; 52.3 Percentage of bleeding sites — p=0.05

Primary: Oral Intake in ml/kg — 9.7; 10.7 oral intake in ml/kg

Primary: Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks — 0.11; 0.19 Score on scale — p=<0.0001

Primary: Change in Pain Scores — 2 score on a scale

Primary: Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool — 1.69; 5.2; 4.54; 5.15…

Primary: Maximum Tolerated Dose — 8 J/cm2

Primary: Number of Participants With Clinical Efficacy — 76; 73 participants

Primary: Duration of Severe Oral Mucositis (WHO Grade 3 or 4) — 4.5; 4.5 Number of days

Primary: Change in Interleukin 1 B at Base to 24 Hours — -1.075; 1.013 Micrograms per deciliter (ug/dl) — p=0.90

Primary: The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. — 2.4; 2.45; 1.6; 2.27…

Primary: Abrasion Assessment (Number) — 3.65; 4.11 number of abrasions

Primary: Participants That Developed Severity Score 3 or Higher Oral Chronic Graft Versus Host Disease (GVHD). — 7; 4 Participants