Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
A legfontosabb adatok
- Ki végzi
- Tufts University
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Fázis
- Korai 1. fázis
- Kezdés
- 2025. máj. 1.
- Várható befejezés
- 2027. szept. 1.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- dexamethasone oral rinse
- A regiszteradat frissítve
- 2025. május 14.
- Miért állt le
- Study protocol changed to be a retrospective exempt review project.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- Over 18 years old
- Non-pregnant
- Newly diagnosed subjects with OLP/OLR. Definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with OLP or OLR for the first time
- Those not exposed to topical or systemic corticosteroids for the previous 1 month. Meaning, those willing to not take this OLP/OLR treatment for 1 month before their visit
- Experimental group is clinically diagnosed with OLP/OLR
- Controls must have no history of OLP/OLR
Ki nem vehet részt
- History of advanced kidney, liver disease, or systemic fungal infection. 5. Corticosteroids hypersensitivity. 6. Active oral candidiasis 7. Patients on blood thinners medication ,anemic or suffer from bleeding disorders
- 1 . Under 18 years old 2. Pregnant women 3. Recent history (< than one month) of exposure to topical or systemic corticosteroids
Helyszínek itt: Egyesült Államok
- Tufts University School of Dental MedicineBoston, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
The objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) and healthy subjects (those who do not have OLP or OLR aka the control group).
A vizsgálat 3 csoportja
- Investigative group- Those with OLPA vizsgált kezelés
The investigative will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
Kezelés: dexamethasone oral rinse
- Control 1 - 5 minute rinseMár használt kezelés, összehasonlításként
The first control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 5 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
Kezelés: dexamethasone oral rinse
- Control 2- 2 minute rinseMár használt kezelés, összehasonlításként
The second control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
Kezelés: dexamethasone oral rinse
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2025. május 14.