Oral SurgeriesPhase 4NCT05467436
Evaluation of Pharmacogenomics Testing to Precision Prescriptions in Periodontal Patients
A Phase 4 study testing Local anesthetics, IV sedation drugs and analgesics. in people with Oral Surgeries, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Surgeries
- What is being tested?
- Local anesthetics, IV sedation drugs and analgesics.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects at least 18 years of age
- All potential subjects must sign an informed consent prior to study enrollment
- Subjects willing to receive a standard full-mouth periodontal examination
- Subjects planned for 2 or more periodontal surgeries.
Who cannot join
- Subjects with medical conditions that contraindicate periodontal surgeries. These medical condition include: recent myocardial infarction and cerebrovascular accident, recent valve prosthesis surgery, immunosuppression, uncontrolled bleeding disorders, active treatment of malignancy as well as intravenous bisphosphonate use.
- Subjects with back and neck injuries that will not allow them to be in supine position.
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University-Dental College of Georgia
Augusta, Georgia, 30912
About this study
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.
Read the detailed description
The objective of this study is to combine pharmacogenomics testing with social, dietary and medications history to formulate individualized-prescription plan and to test the effectiveness of this precession approach to reduce adverse drug reaction and improve pain management during and after periodontal surgeries.
The specific aims of the study are:
- Specific aim 1: To test the efficacy of combining pharmacogenomics, dietary habits as well as social and medical history data to tailor a personalized prescription for each periodontal patient.
- Specific aim 2: To determine the ability of personalized prescription to achieve more efficacious pain management during and after periodontal surgery. The study also aims to determine the effect of this approach in the adjustment of opioid dosages for these patients.
- Specific aim 3: To determine the effect of personalized prescription, using pharmacogenomics tool, on post-surgical complications related to medications.
Self-controlled case series (SCCS) design will be used for the study. After eligibility has been ascertained and consent has been obtained, subjects planned for 2 surgeries will be enrolled in the study. First surgery will be carried out with the standard prescription for medications. For the second surgery, medications will be prescribed based on individualized assessment and pharmacogenomics report for each subject. These medications will be prescribed based on a consult with the periodontal surgeon's and PhamD investigators of the study. Medications that will be assessed in the study are: local anesthetics, IV sedation drugs and analgesics.
- Conditions
- Oral Surgeries
- Being tested
- Local anesthetics, IV sedation drugs and analgesics.
- Keywords
- Pharmacogenomics, Precision prescriptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetics, IV sedation drugs and analgesics.Drug
Personalized prescription for local anesthetics, IV sedation drugs and analgesics, based on pharmacogenomic assesment, social, dietary and medication history
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subject will receive standard prescription for local anesthetics, IV sedation drugs and analgesics at the time of first surgery.
Subject will receive individually tailored-prescription for local anesthetics, IV sedation drugs and analgesics, based upon pharmacogenomic assessment at the time of second surgery. Receives: Drug: Local anesthetics, IV sedation drugs and analgesics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subject-reported post-surgery pain levels
Patient 's assessment of the pain on a scale of 0-10 in the first week after the surgery
Measured: Average of pain ratings, recorded after each surgery in the first week after the surgery. Patient will receive 1 call every 2 days to report his/her pain scale. Patient will receive a total of 3 calls in the 1st week after surgery.
Changes in post-surgery complications related to medications
Post-operative complication will be classified for 6 grades.
Measured: Post-operative complication will be assessed 2-4 weeks after the surgery
Secondary outcomes (1)
Changes in post-surgery sedation assessment
Evaluated using Riker Sedation-Agitation Scale
Measured: Evaluated by the surgeon at the same day of the surgery where sedation performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jan 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral SurgeriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Awady, Augusta University
- Investigators
- Ahmed El-Awady, BDS, MS, PhD, Principal investigator, Dental College of Georgia-Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467436
- Sponsor's protocol ID
- 1490009
- Status last verified
- Jul 2022
- First submitted
- 23 Feb 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacogenomics Testing to Precision Prescriptions in Periodontal Patients
- ClinicalTrials.gov ID
- NCT05467436
- Acronym / sponsor ID
- 1490009
- Conditions
- Oral Surgeries
- Keywords
- Pharmacogenomics, Precision prescriptions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to combine pharmacogenomics testing with social, dietary and medications history to formulate individualized-prescription plan and to test the effectiveness of this precession approach to reduce adverse drug reaction and improve pain management during and after periodontal surgeries.
The specific aims of the study are:
- Specific aim 1: To test the efficacy of combining pharmacogenomics, dietary habits as well as social and medical history data to tailor a personalized prescription for each periodontal patient.
- Specific aim 2: To determine the ability of personalized prescription to achieve more efficacious pain management during and after periodontal surgery. The study also aims to determine the effect of this approach in the adjustment of opioid dosages for these patients.
- Specific aim 3: To determine the effect of personalized prescription, using pharmacogenomics tool, on post-surgical complications related to medications.
Self-controlled case series (SCCS) design will be used for the study. After eligibility has been ascertained and consent has been obtained, subjects planned for 2 surgeries will be enrolled in the study. First surgery will be carried out with the standard prescription for medications. For the second surgery, medications will be prescribed based on individualized assessment and pharmacogenomics report for each subject. These medications will be prescribed based on a consult with the periodontal surgeon's and PhamD investigators of the study. Medications that will be assessed in the study are: local anesthetics, IV sedation drugs and analgesics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Local anesthetics, IV sedation drugs and analgesics.Subject will receive standard prescription for local anesthetics, IV sedation drugs and analgesics at the time of first surgery. Subject will receive individually tailored-prescription for local anesthetics, IV sedation drugs and analgesics, based upon pharmacogenomic assessment at the time of second surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects at least 18 years of age
- All potential subjects must sign an informed consent prior to study enrollment
- Subjects willing to receive a standard full-mouth periodontal examination
- Subjects planned for 2 or more periodontal surgeries.
Key exclusion criteria (2 listed)
- Subjects with medical conditions that contraindicate periodontal surgeries. These medical condition include: recent myocardial infarction and cerebrovascular accident, recent valve prosthesis surgery, immunosuppression, uncontrolled bleeding disorders, active treatment of malignancy as well as intravenous bisphosphonate use.
- Subjects with back and neck injuries that will not allow them to be in supine position.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Experimental group |
Primary outcome
Change in subject-reported post-surgery pain levels
Time frame: Average of pain ratings, recorded after each surgery in the first week after the surgery. Patient will receive 1 call every 2 days to report his/her pain scale. Patient will receive a total of 3 calls in the 1st week after surgery.
Patient 's assessment of the pain on a scale of 0-10 in the first week after the surgery
Changes in post-surgery complications related to medications
Time frame: Post-operative complication will be assessed 2-4 weeks after the surgery
Post-operative complication will be classified for 6 grades.
1 secondary outcome
Changes in post-surgery sedation assessment
Time frame: Evaluated by the surgeon at the same day of the surgery where sedation performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed El-Awady, BDS, MS, PhD principal investigator
Dental College of Georgia-Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local anesthetics, IV sedation drugs and analgesics. in people with Oral Surgeries, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subject-reported post-surgery pain levels (time frame: Average of pain ratings, recorded after each surgery in the first week after the surgery. Patient will receive 1 call every 2 days to report his/her pain scale. Patient will receive a total of 3 calls in the 1st week after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.