Local InfiltrationPhase 1NCT06980363
Hyaluronidase Enzymes and Local Anesthesia
A Phase 1 study testing traditional inferior alveolar nerve block by articaine and hyaluronidase plus articain buccal infilteration in people with Local Infiltration, run by Fayoum University.
Trial summary
For both groups, local anaesthesia will be administered by one single surgeon and the extraction will be performed by another single surgeon across all subjects. The surgeon performing the extraction will be blinded with regard to the local anaesthesia technique used in this study A buccal infiltration injection of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Infiltration
- What is being tested?
- traditional inferior alveolar nerve block by articaine and hyaluronidase plus articain buccal infilteration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 27 Aug 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Medically stable patients
- Seeking for non surgical extraction of mandibular molar tooth
Who cannot join
- history of metabolic or systemic diseases affecting bone or healing process,
- local infection
- Grade III mobility
- Neurological disorder
- an analgesic use within 24 hours before anaesthesia administration
About this study
Official title: Efficacy of Articaine Plus Hyaluronidase Enzymes Infiltration Versus Traditional Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars
- For both groups, local anaesthesia will be administered by one single surgeon and the extraction will be performed by another single surgeon across all subjects. The surgeon performing the extraction will be blinded with regard to the local anaesthesia technique used in this study
- A buccal infiltration injection of 1.5 ml of 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.) plus 1.5 ml of hyaluronidase enzyme (7.5IU/1ml) will be used in the study group while use 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.)only in traditional inferior alveolar nerve block in the control group
- In study and control groups, VAS (visual analogue scale=is an unmarked, continuous, horizontal,100-mm line, anchored by the end points of "no pain" on the left and "worst pain" on the right ) will be used to evaluate the pain levels of the patients associated with the injection and during extraction
- Conditions
- Local Infiltration
- Being tested
- traditional inferior alveolar nerve block by articaine, hyaluronidase plus articain buccal infilteration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional inferior alveolar nerve block by articaineDrug
use articaine for inferior alveolar nerve block with buccal infiltration to anesthetized lower molar teeth
hyaluronidase plus articain buccal infilterationDrug
use of articain plus hyaluronidase enzyme buccal infiltration to anesthetized lower molar teeth
| Study group | Role | What they receive |
|---|---|---|
| traditional inferior alveolar nerve block by articaine | Active comparator | Not described Receives: Drug: traditional inferior alveolar nerve block by articaine |
| hyaluronidase plus articain buccal infiltration | Experimental | Not described Receives: Drug: hyaluronidase plus articain buccal infilteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)0_10
Ask the patient to scoring his pain during the extraction by visualanalogue scale0_10 as 0 no pain and 10 sever pain
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion27 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local InfiltrationStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980363
- Sponsor's protocol ID
- 2222
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Articaine Plus Hyaluronidase Enzymes Infiltration Versus Traditional Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars
- ClinicalTrials.gov ID
- NCT06980363
- Acronym / sponsor ID
- 2222
- Conditions
- Local Infiltration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 27 Aug 2025 (estimated)
- First posted
- 20 May 2025 (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.
- For both groups, local anaesthesia will be administered by one single surgeon and the extraction will be performed by another single surgeon across all subjects. The surgeon performing the extraction will be blinded with regard to the local anaesthesia technique used in this study
- A buccal infiltration injection of 1.5 ml of 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.) plus 1.5 ml of hyaluronidase enzyme (7.5IU/1ml) will be used in the study group while use 4% articaine with 1:100,000 adrenaline (Septocaine, Septodont, New Castle, Del.)only in traditional inferior alveolar nerve block in the control group
- In study and control groups, VAS (visual analogue scale=is an unmarked, continuous, horizontal,100-mm line, anchored by the end points of "no pain" on the left and "worst pain" on the right ) will be used to evaluate the pain levels of the patients associated with the injection and during extraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional inferior alveolar nerve block by articaine | Active comparator | Drug: traditional inferior alveolar nerve block by articaine |
| hyaluronidase plus articain buccal infiltration | Experimental | Drug: hyaluronidase plus articain buccal infilteration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medically stable patients
- Seeking for non surgical extraction of mandibular molar tooth
Key exclusion criteria (5 listed)
- history of metabolic or systemic diseases affecting bone or healing process,
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 |
|---|---|---|
| traditional inferior alveolar nerve block by articaineuse articaine for inferior alveolar nerve block with buccal infiltration to anesthetized lower molar teeth | Drug | traditional inferior alveolar nerve block by articaine |
| hyaluronidase plus articain buccal infilterationuse of articain plus hyaluronidase enzyme buccal infiltration to anesthetized lower molar teeth | Drug | hyaluronidase plus articain buccal infiltration |
Primary outcome
visual analogue scale (VAS)0_10
Time frame: Periprocedural
Ask the patient to scoring his pain during the extraction by visualanalogue scale0_10 as 0 no pain and 10 sever pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing traditional inferior alveolar nerve block by articaine and hyaluronidase plus articain buccal infilteration in people with Local Infiltration, run by Fayoum University.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
visual analogue scale (VAS)0_10 (time frame: Periprocedural). 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 May 2025.