Periodontal DiseasesEarly Phase 1NCT06293807
Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine
A Early Phase 1 study testing Xylocaine 2 % with 1:100,000 epinephrine and Bupivicaine 0.5% with 1:200,000 epinephrine in people with Periodontal Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Xylocaine 2 % with 1:100,000 epinephrine and Bupivicaine 0.5% with 1:200,000 epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 16 Apr 2023
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and…
- require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and…
- require IV sedation and local anesthesia or local anesthesia only…
- in either the maxillary or mandibular arch.
Who cannot join
- Pregnancy, or those planning to become pregnant
- allergy or any medical issue using Lidocaine or Bupivacaine
- inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
- non-English speaking
- not possessing an I-phone or Android device
- patients requiring narcotic for IV sedation
- patients requiring either IV or oral steroids during the perioperative period
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine: A Short-term Clinical Response
Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.
Read the detailed description
This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.
- Conditions
- Periodontal Diseases
- Being tested
- Xylocaine 2 % with 1:100,000 epinephrine, Bupivicaine 0.5% with 1:200,000 epinephrine, Placebo
- Keywords
- Flap debridement, Flap osseous, Tooth extractions, Guided Tissue Regeneration, IV sedation, Local anesthesia
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylocaine 2 % with 1:100,000 epinephrineDrug
Also called Lidocaine
Local anesthetic used during dental procedures
Bupivicaine 0.5% with 1:200,000 epinephrineDrug
Also called Marcaine
Local anesthetic used during dental procedures
PlaceboOther
Also called Normal Saline 0.9%
0.9% Normal Saline solution used in place of local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Treatment group Xylocaine | Experimental | Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. Receives: Drug: Xylocaine 2 % with 1:100,000 epinephrine |
| Treatment group Bupivicaine | Experimental | Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. Receives: Drug: Bupivicaine 0.5% with 1:200,000 epinephrine |
| Placebo control group | Placebo comparator | Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain using Visual Analog Scale (VAS)
Pain response recorded using a 20 point visual Analog Scale. The VAS scale is a straight line scale scored from 0-20 with 0 indicating the least amount of pain and 20 the worst pain ever experienced.
Measured: Baseline to 48 hours
Number of Ibuprofen administered
Additive number of ibuprofen taken over monitoring period
Measured: Baseline to 48 hours
Number of Tylenol administered
Additive number of acetaminophen taken over monitoring period
Measured: Baseline to 48 hours
Secondary outcomes (5)
Arch Response
Difference in pain response based upon arch
Measured: Baseline to 48 hours
Number of teeth
Difference in pain response based upon number of teeth per surgical site
Measured: Baseline to 48 hours
Type of procedure
Difference in pain response based upon type of procedure
Measured: Baseline to 48 hours
Gender of patient
Difference in pain response based upon gender of participant
Measured: Baseline to 48 hours
Age of patient
Difference in pain response based upon age of participant
Measured: Baseline to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start6 Jun 2022
- Primary completion16 Apr 2023
- Study completion16 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, parallel design study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Deas, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293807
- Sponsor's protocol ID
- 20220162HU
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will share all collected deidentified IPD, all deidentified IPD that underlie results in a publication with colleagues.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine: A Short-term Clinical Response
- ClinicalTrials.gov ID
- NCT06293807
- Acronym / sponsor ID
- 20220162HU
- Conditions
- Periodontal Diseases
- Keywords
- Flap debridement, Flap osseous, Tooth extractions, Guided Tissue Regeneration, IV sedation, Local anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 16 Apr 2023 (actual)
- Study completion
- 16 Apr 2023 (actual)
- First posted
- 5 Mar 2024 (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.
Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.
Detailed description
This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A randomized, placebo-controlled, parallel design study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group Xylocaine | Experimental | Drug: Xylocaine 2 % with 1:100,000 epinephrineParticipants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. |
| Treatment group Bupivicaine | Experimental | Drug: Bupivicaine 0.5% with 1:200,000 epinephrineParticipants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. |
| Placebo control group | Placebo comparator | Other: PlaceboParticipants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and…
- require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and…
- require IV sedation and local anesthesia or local anesthesia only…
- in either the maxillary or mandibular arch.
Key exclusion criteria (7 listed)
- Pregnancy, or those planning to become pregnant
- allergy or any medical issue using Lidocaine or Bupivacaine
- inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
- non-English speaking
- not possessing an I-phone or Android device
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 |
|---|---|---|
| Xylocaine 2 % with 1:100,000 epinephrineAlso: LidocaineLocal anesthetic used during dental procedures | Drug | Treatment group Xylocaine |
| Bupivicaine 0.5% with 1:200,000 epinephrineAlso: MarcaineLocal anesthetic used during dental procedures | Drug | Treatment group Bupivicaine |
| PlaceboAlso: Normal Saline 0.9%0.9% Normal Saline solution used in place of local anesthetic | Other | Placebo control group |
Primary outcome
Change in pain using Visual Analog Scale (VAS)
Time frame: Baseline to 48 hours
Pain response recorded using a 20 point visual Analog Scale. The VAS scale is a straight line scale scored from 0-20 with 0 indicating the least amount of pain and 20 the worst pain ever experienced.
Number of Ibuprofen administered
Time frame: Baseline to 48 hours
Additive number of ibuprofen taken over monitoring period
Number of Tylenol administered
Time frame: Baseline to 48 hours
Additive number of acetaminophen taken over monitoring period
5 secondary outcomes
Arch Response
Time frame: Baseline to 48 hours
Number of teeth
Time frame: Baseline to 48 hours
Type of procedure
Time frame: Baseline to 48 hours
Gender of patient
Time frame: Baseline to 48 hours
Age of patient
Time frame: Baseline to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: Yes. The PI will share all collected deidentified IPD, all deidentified IPD that underlie results in a publication with colleagues.
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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.
David Deas, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Xylocaine 2 % with 1:100,000 epinephrine and Bupivicaine 0.5% with 1:200,000 epinephrine in people with Periodontal Diseases, run by The University of Texas Health Science Center at San Antonio 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 7 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: finished, as of the sponsor's last update on 8 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 pain using Visual Analog Scale (VAS) (time frame: Baseline to 48 hours). The study lists 3 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 8 Mar 2024.