Local AnesthesiaPhase 4NCT05793905
Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars
A Phase 4 study testing Buffered lidocaine in inferior alveolar nerve block injection and lidocaine 2% in inferior alveolar nerve block injection in people with Local Anesthesia, run by Damascus University at 1 site in Syria.
Trial summary
In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- Buffered lidocaine in inferior alveolar nerve block injection and lidocaine 2% in inferior alveolar nerve block injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2022to 3 Apr 2023
- Phase
- Phase 4
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer.
- Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate).
- Children aged 6-10 years old
- Cooperative children on Frankel scale (positive or absolute positive).
- children needing bilateral (right and left) endodontic treatment for the mandibular primary molars.
- A positive outcome on the cold test for the target tooth.
Who cannot join
- Uncooperative children on Frankel's scale (passive or absolute positive).
- The presence of a fistula.
- The presence of an abscess associated with the target tooth.
- The presence of a periapical lesion radially.
- Negative response to the cold test.
- Children suffering from systemic conditions.
- Children who are allergic to (lidocaine, adrenaline, sodium bicarbonate).
Trial locations and contacts
1 site in 1 country.
Syria1 site
College of dentistry.
Damascus, Al-Mazzeh Saint, Damascus P.O.Box 3062
About this study
Official title: Evaluation of the Effect of Buffered Anesthetic Solution (Lidocaine 2%) in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars
In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice has been used to assess the onset of pulp anesthesia.
Read the detailed description
In a prospective, randomized clinical trial and triple-blind, split mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. Random numbers between 1 to 40 were assigned to patients, with some receiving buffered lidocaine at their initial appointment while others received unbuffered lidocaine. The solutions have been switched up for the second session, which has been set for one week later. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, non-buffering 2% lidocaine with 1:80,000 epinephrine. Buffered lidocaine has been freshly prepared by mixing sodium bicarbonate (8.4%) with the anaesthetic solution (lidocaine 2% with epinephrine 1/80.000) in a 1:10 ratio by volume. Two percent benzocaine gel is applied at the injection site for one minute before inferior alveolar nerve block injection (IANB). The investigator has assessed pain during IANB injection using the subjective Wong-Baker visual analogue scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. After administering the IANB injection, the investigator has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva every 30 seconds until there is no pain. Endo-ice has been used to assess the onset of pulp anaesthesia every 30 seconds. The effectiveness of anaesthesia has been assessed during the preparation of the pulp chamber using subjective, objective, and physiological pain scales. Finally, the numerical data will be statistically analysed, and any statistically significant values will be investigated.
- Conditions
- Local Anesthesia
- Being tested
- Buffered lidocaine in inferior alveolar nerve block injection, lidocaine 2% in inferior alveolar nerve block injection
- Keywords
- Buffered lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered lidocaine in inferior alveolar nerve block injectionCombination product
Also called Buffered lidocaine
Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars
lidocaine 2% in inferior alveolar nerve block injectionDrug
Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars
| Study group | Role | What they receive |
|---|---|---|
| Buffered lidocaine | Experimental | Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%) Receives: Combination Product: Buffered lidocaine in inferior alveolar nerve block injection |
| Lidocaine 2% | Other | Control group:
Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000). Receives: Drug: lidocaine 2% in inferior alveolar nerve block injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing the gingiva
The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.
Measured: directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.
Endo - ice test
The investigator will use endo-ice to assess the onset time of pulp anaesthesia.
Measured: Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.
Pulse rate
Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
Measured: A minute before anaesthesia.
Pulse rate
Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.
Measured: 20 seconds after the first quarter of the local anaesthesia.
Wong baker faces scale.
Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"
Measured: One minute after IANB injection
Sound, eye, motor scale (SEM)
Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia
Measured: Within five seconds from the start of the local anesthetic injection to completion
Secondary outcomes (3)
Pulse rate
Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
Measured: 20 seconds after opening the pulp chamber
Wong baker faces scale
Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"
Measured: one minute after preparing pulp chamber
sound, eye, motor scale (SEM)
Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during endo access preparation
Measured: Within five seconds from the start of the local anaesthetic injection to completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Mar 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaza Kouchaji, Professor, Study director, SupervisalHanadi Almattit, Phd,lecturer, Study director, Co- supervisal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793905
- Sponsor's protocol ID
- UDDS-Pedo-03-2023
- Status last verified
- Sep 2023
- First submitted
- 7 Feb 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chopra R, Jindal G, Sachdev V, Sandhu M. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children. Pediatr Dent. 2016 Jan-Feb;38(1):25-9.
PubMed 26892211Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.
PubMed 31478693Meincken M, Norman C, Arevalo O, Saman DM, Bejarano T. Anesthesia Onset Time and Injection Pain Between Buffered and Unbuffered Lidocaine Used as Local Anesthetic for Dental Care in Children. Pediatr Dent. 2019 Sep 15;41(5):354-357.
PubMed 31648665Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.
PubMed 30087760
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Buffered Anesthetic Solution (Lidocaine 2%) in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars
- ClinicalTrials.gov ID
- NCT05793905
- Acronym / sponsor ID
- UDDS-Pedo-03-2023
- Conditions
- Local Anesthesia
- Keywords
- Buffered lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 31 Mar 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.
In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice has been used to assess the onset of pulp anesthesia.
Detailed description
In a prospective, randomized clinical trial and triple-blind, split mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. Random numbers between 1 to 40 were assigned to patients, with some receiving buffered lidocaine at their initial appointment while others received unbuffered lidocaine. The solutions have been switched up for the second session, which has been set for one week later. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, non-buffering 2% lidocaine with 1:80,000 epinephrine. Buffered lidocaine has been freshly prepared by mixing sodium bicarbonate (8.4%) with the anaesthetic solution (lidocaine 2% with epinephrine 1/80.000) in a 1:10 ratio by volume. Two percent benzocaine gel is applied at the injection site for one minute before inferior alveolar nerve block injection (IANB). The investigator has assessed pain during IANB injection using the subjective Wong-Baker visual analogue scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. After administering the IANB injection, the investigator has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva every 30 seconds until there is no pain. Endo-ice has been used to assess the onset of pulp anaesthesia every 30 seconds. The effectiveness of anaesthesia has been assessed during the preparation of the pulp chamber using subjective, objective, and physiological pain scales. Finally, the numerical data will be statistically analysed, and any statistically significant values will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars
| Arm | Type | Receives |
|---|---|---|
| Buffered lidocaine | Experimental | Combination Product: Buffered lidocaine in inferior alveolar nerve block injectionInferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%) |
| Lidocaine 2% | Other | Drug: lidocaine 2% in inferior alveolar nerve block injectionControl group: Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000). |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer.
- Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate).
- Children aged 6-10 years old
- Cooperative children on Frankel scale (positive or absolute positive).
- children needing bilateral (right and left) endodontic treatment for the mandibular primary molars.
Key exclusion criteria (7 listed)
- Uncooperative children on Frankel's scale (passive or absolute positive).
- The presence of a fistula.
- The presence of an abscess associated with the target tooth.
- The presence of a periapical lesion radially.
- Negative response to the cold test.
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 |
|---|---|---|
| Buffered lidocaine in inferior alveolar nerve block injectionAlso: Buffered lidocaineBuffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars | Combination product | Buffered lidocaine |
| lidocaine 2% in inferior alveolar nerve block injectionLidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars | Drug | Lidocaine 2% |
Primary outcome
Probing the gingiva
Time frame: directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.
The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.
Endo - ice test
Time frame: Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain.
The investigator will use endo-ice to assess the onset time of pulp anaesthesia.
Pulse rate
Time frame: A minute before anaesthesia.
Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
Pulse rate
Time frame: 20 seconds after the first quarter of the local anaesthesia.
Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.
Wong baker faces scale.
Time frame: One minute after IANB injection
Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst"
Sound, eye, motor scale (SEM)
Time frame: Within five seconds from the start of the local anesthetic injection to completion
Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia
3 secondary outcomes
Pulse rate
Time frame: 20 seconds after opening the pulp chamber
Wong baker faces scale
Time frame: one minute after preparing pulp chamber
sound, eye, motor scale (SEM)
Time frame: Within five seconds from the start of the local anaesthetic injection to completion
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 29 Sep 2023.
- Results publication: PubMed 26892211Chopra R, Jindal G, Sachdev V, Sandhu M. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children. Pediatr Dent. 2016 Jan-Feb;38(1):25-9.
- Results publication: PubMed 31478693Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.
- Results publication: PubMed 31648665Meincken M, Norman C, Arevalo O, Saman DM, Bejarano T. Anesthesia Onset Time and Injection Pain Between Buffered and Unbuffered Lidocaine Used as Local Anesthetic for Dental Care in Children. Pediatr Dent. 2019 Sep 15;41(5):354-357.
- Results publication: PubMed 30087760Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.
- 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.
Chaza Kouchaji, Professor study director
Supervisal
Hanadi Almattit, Phd,lecturer study director
Co- supervisal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buffered lidocaine in inferior alveolar nerve block injection and lidocaine 2% in inferior alveolar nerve block injection in people with Local Anesthesia, run by Damascus University at 1 site in Syria.
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 6 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 29 Sep 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 Syria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Probing the gingiva (time frame: directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05793905, which also lists 4 linked publications.
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 29 Sep 2023.