Health Condition 1: G20- Parkinsons disease
Conditions
Interventions
Intervention1: Levodopa: Oral and Maxillofacial Route-100ul Liquid Formulation, One Dose, Day 1.
Control Intervention1: Levodopa and Carbidopa: Oral Route - Routine daily tablet of the patient in mg,
Sponsors
SURESH CT
UR Anoop Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Idiopathic Parkinsonâ??s disease reporting with dental caries with pulpitis and requiring root canal treatment for maxillary posterior teeth. 2. Consenting adult patients with idiopathic Parkinsonâ??s disease. 3. Patients with no systemic or local contra-indications for root canal procedure or implant placement. 4. Patients requiring oral Levodopa/ Carbidopa medication and on regular medication regimen. 5. Patients experiencing motor fluctuations and dyskinesia demonstrating Levodopa responsiveness. 6. Hoehn and Yahr Stage 1-3 while â??ONâ?? with oral Levodopa/Carbidopa. 7.Normal cognition confirmed by MMSE score > 25
Exclusion criteria
Exclusion criteria: 1.Patients with Parkinsonâ??s plus syndromes and Parkinsonâ??s patients with dementia. 2.Patients with history of psychosis. 3.Patients who are already on device assisted therapies. 4.Patients who have been advised to undergo stereotactic surgery. 5.Patients with systemic contraindications for undergoing the root canal procedure or implant placement. 6.Patients with acute oral infections. 7.Patients with maxillary sinus infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the efficacy of the Oral and Maxillofacial route of drug administration by evaluating whether the Unified Parkinsonâ??s Disease Rating Scale improves from the pre-dose score to the post-dose score at 30 minutes after administration of Levodopa through the oral and maxillofacial route on day 1.Timepoint: Predose and 30 minutes post dose on day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the efficacy of administration of Levodopa through the Oral and Maxillofacial route with the administration of Levodopa/Carbidopa through the oral route based on the pre-dose and 30 minutes post-dose scores as per Unified Parkinsonâ??s Disease Rating Scale. 2.To assess whether the Oral and Maxillofacial route can produce a quick â??ONâ?? C.To assess whether the Oral and Maxillofacial route can sustain the quick â??ONâ?? D.To assess in the future whether frequent dosing using low doses through the Oral and Maxillofacial route can reduce dyskinesia. E.To compare the plasma levels of orally administered Levodopa/Carbidopa with Levodopa administered through the Oral and Maxillofacial route at pre dose and 30 minutes post dose. Timepoint: Predose and 30 minutes post dose on day 1 | — |
Countries
India
Contacts
Public ContactSURESH CT
INDIRA GANDHI GOVT GENERAL HOSPITAL & POST GRADUATE INSTITUTE.
Outcome results
None listed