Anesthesia, LocalNCT05875350
Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars
A study testing Intraligamental local anesthetic injection in people with Anesthesia, Local, run by Minia University at 1 site in Egypt.
Trial summary
The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Intraligamental local anesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 15 Apr 2023
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy patients (class I category according to American society of anesthesiologists )
- Age range: 20 - 60 years of age,
- Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.
Who cannot join
- Patients with tooth that require trans osseous extraction
- Badly broken down coronal structure of the tooth to be extracted
- Patients with significant medical conditions
- Alcoh intake
- Patients on drugs that affect the central nervous systems
- Patients who reported the use of drugs that might interfere with pain sensitivity
- Pregnant or lactating women
- Patients who suffer from hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Low Dose Intraligamental Local Anesthesia as an Alternative for Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars: Double Blind Randomized Clinical Trial
The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.
- Conditions
- Anesthesia, Local
- Being tested
- Intraligamental local anesthetic injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraligamental local anesthetic injectionProcedure or surgery
The intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt)
| Study group | Role | What they receive |
|---|---|---|
| Intraligamental local anesthetic injection | Experimental | Not described Receives: Procedure: Intraligamental local anesthetic injection |
| Buccal infiltration local anesthetic injection | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using visual analogue scale
visual analogue scale (VAS) was used in which a pain score was recorded for each patient just after local anesthetic adminstration. The VAS score ranges from 0 (no pain) to 10 (extreme unbearable pain)
Measured: immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Mar 2023
- Primary completion30 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Abdelbarry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875350
- Sponsor's protocol ID
- 716
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose Intraligamental Local Anesthesia as an Alternative for Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars: Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05875350
- Acronym / sponsor ID
- 716
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 25 May 2023 (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 study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraligamental local anesthetic injection | Experimental | Procedure: Intraligamental local anesthetic injection |
| Buccal infiltration local anesthetic injection | No intervention | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy patients (class I category according to American society of anesthesiologists )
- Age range: 20 - 60 years of age,
- Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.
Key exclusion criteria (8 listed)
- Patients with tooth that require trans osseous extraction
- Badly broken down coronal structure of the tooth to be extracted
- Patients with significant medical conditions
- Alcoh intake
- Patients on drugs that affect the central nervous systems
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 |
|---|---|---|
| Intraligamental local anesthetic injectionThe intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt) | Procedure or surgery | Intraligamental local anesthetic injection |
Primary outcome
Pain using visual analogue scale
Time frame: immediately after injection
visual analogue scale (VAS) was used in which a pain score was recorded for each patient just after local anesthetic adminstration. The VAS score ranges from 0 (no pain) to 10 (extreme unbearable pain)
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 31 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraligamental local anesthetic injection in people with Anesthesia, Local, run by Minia University at 1 site in Egypt.
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 3 inclusion and 8 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 31 May 2023. 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 Egypt. 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.
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?
Pain using visual analogue scale (time frame: immediately after injection). 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 31 May 2023.