Anesthesia, LocalNCT05122819
Evaluation of Efficacy of Intraligamentary Anesthesia for Mandibular Molar Extractions
A study testing Mandibular Molar Extraction Under Local Anesthesia in people with Anesthesia, Local, run by Hamdard University at 1 site in Pakistan.
Trial summary
Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Mandibular Molar Extraction Under Local Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2022to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and above
- Both genders.
- Teeth selection: Mandibular first and second molars needing extraction under local anaesthesia.
- Healthy patients or those with well controlled systemic disease.
- Patients consenting to participate in the study.
Who cannot join
- Patients younger than 18 years.
- Mandibular third molars, acutely inflamed or infected first and second molars.
- Pregnant patients and those with poorly controlled systemic disease.
- Mentally handicapped patients.
- Patients not consenting to participate in the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Hamdard University Dental Hospital
Karachi, Sindh
Ayesha Basit, BDS, MCPS, FCPS, 923332257147, ayeshabasitpk@gmail.com
Maham Naeem, BDS, MBA, 923342886298, drmaham.naeem@gmail.com
About this study
Official title: Evaluation of Efficacy of Intraligamentary Anesthesia by Two Different Techniques for Extraction of Mandibular Molars: A Randomized Controlled Trial
Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. The anatomical complexity of this technique carries the risk of anaesthetic failures necessitating repeated needle penetrations and hence a painful experience for the patient. In addition, IANB technique, many times, becomes impossible to perform in fearful adult and paediatric patients, those with restricted mouth opening or intellectual disability. Certain coagulation defects are a contraindication to administration of IANB due to its depth of penetration into the tissues that may lead to fatal consequences in case of uncontrolled bleeding. Because of these shortcomings of IANB, there is always a need for alternative anaesthesia techniques that are less painful and carry lesser risks.
Anaesthetic injection into the Periodontal ligament space (space between tooth root surface and the bone forming the socket wall) as an alternative to IANB have been tested by many researchers with varying results. The expected advantages of this technique are reduced pain on injection, shorter duration of anaesthesia that prevents inadvertent lips and cheek biting after completion of the procedure. It is expected to be easier to perform in cases of restricted mouth opening and uncooperative patients due to any reason and carry lesser risk of bleeding within tissues.
The objective of our study is to evaluate the efficacy of Intra-ligamentary injection for posterior mandibular molar extraction as an alternative to inferior alveolar nerve block (IANB) so that it can be used in cases where IANB is either difficult to perform or not indicated.
- Conditions
- Anesthesia, Local
- Being tested
- Mandibular Molar Extraction Under Local Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Molar Extraction Under Local AnesthesiaProcedure or surgery
Local Anaesthetic to be used: 2% Lidocaine in 1.8 ml cartridge (regularly used for dental anaesthesia regardless of the technique).
Pain on injection and local anaesthesia success will be checked by using numeric pain rating scale (NPRS).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intraligamentary Injection by Jet Injector Receives: Procedure: Mandibular Molar Extraction Under Local Anesthesia |
| Group B | Experimental | Intraligamentary Injection by regular Dental Anesthesia Syringe Receives: Procedure: Mandibular Molar Extraction Under Local Anesthesia |
| Group C | Active comparator | Inferior Alveolar Nerve Block Receives: Procedure: Mandibular Molar Extraction Under Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on injection
Pain on injection will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.
Measured: Immediately after local anesthesia administration regardless of the technique.
Local anesthesia success
Local anesthesia success will be checked by using Numeric Pain Rating Scale (NPRS).
NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.
Measured: 1 minute after local anesthesia administration by intraligamentary injection regardless of the syringe used. 6 minutes after administration of Inferior Alveolar Nerve Block (IANB).
Secondary outcomes (1)
Successful completion of Extraction
Completion of extraction within 45 minutes, without changing the intervention.
It will be measured on the following parameters:
- Local anesthesia success by NPRS after first administration of Intraligamentary injection (first primary outcome measure mentioned above).
- Local anesthesia success by NPRS after second administration of intraligamentary injection (need to repeat the same technique).
- Local anesthesia failure by Intraligamentary injection administered twice (as mentioned above) and need to change the technique to conventional Inferior Alveolar Nerve Block (IANB).
Measured: 45 minutes from the first administration of local anesthesia injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start13 May 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Basit, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122819
- Sponsor's protocol ID
- (21)3-4161310
- Status last verified
- Feb 2023
- First submitted
- 14 Oct 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Intraligamentary Anesthesia by Two Different Techniques for Extraction of Mandibular Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05122819
- Acronym / sponsor ID
- (21)3-4161310
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 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.
Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. The anatomical complexity of this technique carries the risk of anaesthetic failures necessitating repeated needle penetrations and hence a painful experience for the patient. In addition, IANB technique, many times, becomes impossible to perform in fearful adult and paediatric patients, those with restricted mouth opening or intellectual disability. Certain coagulation defects are a contraindication to administration of IANB due to its depth of penetration into the tissues that may lead to fatal consequences in case of uncontrolled bleeding. Because of these shortcomings of IANB, there is always a need for alternative anaesthesia techniques that are less painful and carry lesser risks.
Anaesthetic injection into the Periodontal ligament space (space between tooth root surface and the bone forming the socket wall) as an alternative to IANB have been tested by many researchers with varying results. The expected advantages of this technique are reduced pain on injection, shorter duration of anaesthesia that prevents inadvertent lips and cheek biting after completion of the procedure. It is expected to be easier to perform in cases of restricted mouth opening and uncooperative patients due to any reason and carry lesser risk of bleeding within tissues.
The objective of our study is to evaluate the efficacy of Intra-ligamentary injection for posterior mandibular molar extraction as an alternative to inferior alveolar nerve block (IANB) so that it can be used in cases where IANB is either difficult to perform or not indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Mandibular Molar Extraction Under Local AnesthesiaIntraligamentary Injection by Jet Injector |
| Group B | Experimental | Procedure: Mandibular Molar Extraction Under Local AnesthesiaIntraligamentary Injection by regular Dental Anesthesia Syringe |
| Group C | Active comparator | Procedure: Mandibular Molar Extraction Under Local AnesthesiaInferior Alveolar Nerve Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and above
- Both genders.
- Teeth selection: Mandibular first and second molars needing extraction under local anaesthesia.
- Healthy patients or those with well controlled systemic disease.
- Patients consenting to participate in the study.
Key exclusion criteria (5 listed)
- Patients younger than 18 years.
- Mandibular third molars, acutely inflamed or infected first and second molars.
- Pregnant patients and those with poorly controlled systemic disease.
- Mentally handicapped patients.
- Patients not consenting to participate in the study.
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 |
|---|---|---|
| Mandibular Molar Extraction Under Local AnesthesiaLocal Anaesthetic to be used: 2% Lidocaine in 1.8 ml cartridge (regularly used for dental anaesthesia regardless of the technique). Pain on injection and local anaesthesia success will be checked by using numeric pain rating scale (NPRS). | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
Pain on injection
Time frame: Immediately after local anesthesia administration regardless of the technique.
Pain on injection will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.
Local anesthesia success
Time frame: 1 minute after local anesthesia administration by intraligamentary injection regardless of the syringe used. 6 minutes after administration of Inferior Alveolar Nerve Block (IANB).
Local anesthesia success will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.
1 secondary outcome
Successful completion of Extraction
Time frame: 45 minutes from the first administration of local anesthesia injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Molar Extraction Under Local Anesthesia in people with Anesthesia, Local, run by Hamdard University 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 5 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: status not confirmed, as of the sponsor's last update on 1 Mar 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 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.
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?
Contact Ayesha Basit, BDS, MCPS, FCPS (923332257147, ayeshabasitpk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on injection (time frame: Immediately after local anesthesia administration regardless of the technique.). 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 1 Mar 2023.