Evaluation of Pharmacogenomics Testing to Precision Prescriptions in Periodontal Patients

NCT05467436 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-07-20

No results posted yet for this study

Summary

The different patients responses to medications vary from dose effectiveness to adverse drug reaction (ADRs). ADRs affect outpatient settings as it account for estimated 1 million emergency department visits and over 3.5 million physician office visits per year. This subsequently results in about 125,000 hospital admissions. Currently, genetic testing conclude recommendation of dose adjustment or drug stop. However, further step is needed toward individually tailored prescription plan. The purpose of this study is to determine if the efficacy of the genetic testing (Pharmacogenomics) combined with the dietary habits and medications history to design an individually tailored prescription plan. This individualized-prescriptions will be tested if to reduce adverse drug reaction and improve pain management in periodontal surgeries. Hence, the current study will recruit subjects planned for two periodontal surgeries and evaluate pain management during and after periodontal surgery as well as post-surgical complication with and without individually tailored prescription plan. In addition, a comparison will be performed on number of drugs added, stopped or had a dose adjustment.

Conditions

  • Oral Surgeries

Interventions

DRUG

Local anesthetics, IV sedation drugs and analgesics.

Personalized prescription for local anesthetics, IV sedation drugs and analgesics, based on pharmacogenomic assesment, social, dietary and medication history

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Ahmed El-Awady, BDS, MS, PhD · Dental College of Georgia-Augusta University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-11-01
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05467436 on ClinicalTrials.gov