LOCAL ANESTHESIAPhase 2NCT04947267
To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor
A Phase 2 study testing 3% Mepivacaine Hydrochloride and 2% Mepivacaine with 1:100,000 epinephrine in people with LOCAL ANESTHESIA, run by Afshan Amjad Ali at 1 site in Pakistan.
Trial summary
As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each… Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- LOCAL ANESTHESIA
- What is being tested?
- 3% Mepivacaine Hydrochloride and 2% Mepivacaine with 1:100,000 epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2018to 19 Nov 2019
- Phase
- Phase 2
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Medical status: healthy individuals with no current and past medical findings.
- Medications: no current medications.
- Both mature vital ipsilateral mandibular premolars:
- Healthy premolar (ICDAS code 0)
- Carious premolar (ICDAS code 4-6).
- Periapical status
Show all 11Show fewer
- Healthy premolar - Periapical Index. (Code 1).
- Carious premolar - Periapical Index. (Code 1).
- Periodontal status
- Healthy premolar - Classification of periodontal diseases and conditions (Code 0).
- Carious premolar - Classification of periodontal diseases and conditions (Code 0).
Who cannot join
- Patients with oral and maxillofacial syndromes and anomalies.
- Pregnant and nursing mothers.
- Class V carious lesions (sensor of pulse oximeter was placed on intact buccal, lingual and cervical surfaces).
- Teeth with extracoronal restorations.
- Teeth with developmental defects and other anomalies.
- Dental trauma.
- Teeth with symptoms of irreversible pulpitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial
As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with Nellcor-550 pulse oximeter and Nellcor D-YS Multisite reusable sensor.
Read the detailed description
BACKGROUND ' Local anesthesia is the foremost requirement of an efficient operative dental procedure to be executed in a pain free and calm environment. Local anesthesia is available in two forms: with vasoconstrictor and without vasoconstrictor. As vasoconstrictors adversely affect pulpal hemodynamics, this study aims to compare the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).
NULL HYPOTHESIS There is no difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.
ALTERNATE HYPOTHESIS There is a difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.
METHOD Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with the Nellcor- PM 10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.
STATISTICAL ANALYSIS The statistical package for social sciences version 21.0 is used for statistical analysis. Mean and standard deviation of the pulpal oxygen saturation levels for filled and unfilled teeth under the effect of 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine were recorded. Mixed Way ANOVA will be applied to discern if there is any difference in the pulpal oxygen saturation levels within and between the two groups. Post Hoc Tuckey was applied to identify whether the paired difference is present within groups or between the two groups.
- Conditions
- LOCAL ANESTHESIA
- Being tested
- 3% Mepivacaine Hydrochloride, 2% Mepivacaine with 1:100,000 epinephrine
- Keywords
- pulpal oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Mepivacaine HydrochlorideDrug
Also called 3% scandonest plain
1.8 ml of 3% mepivacaine (3% Scandonest, Septodont) was administered to Group B patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.
2% Mepivacaine with 1:100,000 epinephrineDrug
Also called 2% scandonest special
1.8 ml of 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special, Septodont) was administered to Group A patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.
| Study group | Role | What they receive |
|---|---|---|
| 3% mepivacaine | Experimental | 3% mepivacaine was administered via inferior alveolar nerve block. Receives: Drug: 3% Mepivacaine Hydrochloride |
| 2% mepivacaine with 1:100,000 epinephrine | Active comparator | 2% mepivacaine with 1:100,000 epinephrine was administered via inferior alveolar nerve block. Receives: Drug: 2% Mepivacaine with 1:100,000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PULPAL OXYGEN SATURATION
Pulpal oxygen saturation levels were recorded for 60 min after administration of local anesthesia using Nellcor-PM10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start30 May 2018
- Primary completion21 Sep 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOCAL ANESTHESIAStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afshan Amjad Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Afshan Amjad Ali, Dow University of Health Sciences
- Investigators
- AFSHAN AMJAD ALI, MSc, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947267
- Sponsor's protocol ID
- AAAli
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04947267
- Acronym / sponsor ID
- AAAli
- Conditions
- LOCAL ANESTHESIA
- Keywords
- pulpal oxygen saturation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Afshan Amjad AliUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 21 Sep 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 1 Jul 2021 (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.
As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with Nellcor-550 pulse oximeter and Nellcor D-YS Multisite reusable sensor.
Detailed description
BACKGROUND ' Local anesthesia is the foremost requirement of an efficient operative dental procedure to be executed in a pain free and calm environment. Local anesthesia is available in two forms: with vasoconstrictor and without vasoconstrictor. As vasoconstrictors adversely affect pulpal hemodynamics, this study aims to compare the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).
NULL HYPOTHESIS There is no difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.
ALTERNATE HYPOTHESIS There is a difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine.
METHOD Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with the Nellcor- PM 10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.
STATISTICAL ANALYSIS The statistical package for social sciences version 21.0 is used for statistical analysis. Mean and standard deviation of the pulpal oxygen saturation levels for filled and unfilled teeth under the effect of 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine were recorded. Mixed Way ANOVA will be applied to discern if there is any difference in the pulpal oxygen saturation levels within and between the two groups. Post Hoc Tuckey was applied to identify whether the paired difference is present within groups or between the two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3% mepivacaine | Experimental | Drug: 3% Mepivacaine Hydrochloride3% mepivacaine was administered via inferior alveolar nerve block. |
| 2% mepivacaine with 1:100,000 epinephrine | Active comparator | Drug: 2% Mepivacaine with 1:100,000 epinephrine2% mepivacaine with 1:100,000 epinephrine was administered via inferior alveolar nerve block. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Medical status: healthy individuals with no current and past medical findings.
- Medications: no current medications.
- Both mature vital ipsilateral mandibular premolars:
- Periapical status
- Periodontal status
Key exclusion criteria (7 listed)
- Patients with oral and maxillofacial syndromes and anomalies.
- Pregnant and nursing mothers.
- Class V carious lesions (sensor of pulse oximeter was placed on intact buccal, lingual and cervical surfaces).
- Teeth with extracoronal restorations.
- Teeth with developmental defects and other anomalies.
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 |
|---|---|---|
| 3% Mepivacaine HydrochlorideAlso: 3% scandonest plain1.8 ml of 3% mepivacaine (3% Scandonest, Septodont) was administered to Group B patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour. | Drug | 3% mepivacaine |
| 2% Mepivacaine with 1:100,000 epinephrineAlso: 2% scandonest special1.8 ml of 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special, Septodont) was administered to Group A patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour. | Drug | 2% mepivacaine with 1:100,000 epinephrine |
Primary outcome
PULPAL OXYGEN SATURATION
Time frame: 60 minutes
Pulpal oxygen saturation levels were recorded for 60 min after administration of local anesthesia using Nellcor-PM10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.
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 1 Jul 2021.
- 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.
AFSHAN AMJAD ALI, MSc principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3% Mepivacaine Hydrochloride and 2% Mepivacaine with 1:100,000 epinephrine in people with LOCAL ANESTHESIA, run by Afshan Amjad Ali at 1 site in Pakistan.
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 11 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 1 Jul 2021. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PULPAL OXYGEN SATURATION (time frame: 60 minutes). 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 1 Jul 2021.