Anesthesia, DentalNCT05839093
Anesthesia Techniques in Symptomatic Mandibular Molars With Irreversible Pulpitis
A study testing Inferior Alveolar Nerve Block Group and Intraligamentary Injection Group in people with Anesthesia, Dental, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to evaluate the success of buccal infiltration (BI) anesthesia + intraligamentary (ILI) anesthesia between inferior alveolar nerve block (IANB) anesthesia + buccal infiltration anesthesia in mandibular molar teeth with acute symptomatic irreversible pulpitis.The main questions it aims… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Dental
- What is being tested?
- Inferior Alveolar Nerve Block Group and Intraligamentary Injection Group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2021to 14 Mar 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy patients
- The absence of periapical pathology
- Not sensitive to articaine or epinephrine
- No facial paresthesia
- Not taking any analgesic drug 6 hours before treatment
- Not taking any medication that interferes with anesthesia, such as tricyclic antidepressants and beta-blockers
Show all 10Show fewer
- The absence of pathosis in areas planned for injection
- Not pregnant
- The absence of pathologic periodontal pockets during probing
- Patients with a mandibular first molar tooth exhibiting symptomatic irreversible pulpitis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University, Faculty of Dentistry, Clinic of Endodontics
Adana
About this study
Official title: Evaluation of the Efficiency of Intraligamentary + Buccal Infiltration Anesthesia and Inferior Alveolar Nerve Block + Buccal Infiltration Anesthesia in Symptomatic Mandibular Molars With Irreversible Pulpitis
The aim of this clinical study is to evaluate the success of buccal infiltration (BI) anesthesia + intraligamentary (ILI) anesthesia between inferior alveolar nerve block (IANB) anesthesia + buccal infiltration anesthesia in mandibular molar teeth with acute symptomatic irreversible pulpitis.The main questions it aims to answer are:
- Does the anesthesia techniques adequate to perform root canal treatment painlessly?
- Which technique achieved pulpal anesthesia? Participants were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. Then, root canal treatment was performed.
Researchers were compared the success of anesthesia techniques in different stages of root canal treatment.
Read the detailed description
A total of 50 patients, aged between 18-65, who were diagnosed with symptomatic irreversible pulpitis of the mandibular molar tooth, were included in this study. The patients were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. After the anesthesia, a rubber dam was placed on the associated tooth of the patient for root canal treatment, the endodontic access cavity was opened, and canal preparation procedures were started. The pain levels felt by the patients during the endodontic treatment stages (starting the treatment, opening the endodontic access cavity and pulp extirpation) were determined by Heft-Parker VAS (HP-VAS) scale. Anesthesia was considered successful in patients who felt no pain (HP-VAS ratio = 0) or mild pain (HP-VAS ratio ≤ 54) during the procedures.
- Conditions
- Anesthesia, Dental
- Being tested
- Inferior Alveolar Nerve Block Group, Intraligamentary Injection Group
- Keywords
- pain, irreversible pulpitis, intraligamentary injection, inferior alveolar nerve block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve Block GroupDevice
A standard IANB injection with a conventional dental injector and a 27-G needle. After determining the injection site and performing aspiration, 1.8 mL of solution was injected at a rate of 1 mL/min to block the inferior alveolar nerve. After achieving lip anesthesia, infiltration was performed at the buccal side of the affected tooth with 0.5 mL using a normal syringe and a 27-G needle. The needle insertion point was the middle of the mesiodistal distance of the crown. Five minutes later, the teeth were isolated and the endodontic procedure was started.
Intraligamentary Injection GroupDevice
An infiltration was performed at the buccal side of the affected tooth with 0.5 mL using a normal syringe and a 27-G needle. Then, an intraligamentary injection was performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle. The needle was placed alongside the tooth and inserted at a 30 angle relative to the longitudinal axis of the crown with the needle between the teeth and the bone. Then, in the mesiobuccal, distobuccal, mesiolingual and distolingual portions of teeth, 0.18 mL of the solution was injected. Five minutes later, the teeth were isolated and the endodontic procedure was started.
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveolar Nerve Block Group | Active comparator | A standard Inferior Alveolar Nerve Block (IANB) injection with a conventional dental injector and a 27-G needle to achieve pulpal anesthesia in mandibular molar teeth. Receives: Device: Inferior Alveolar Nerve Block Group |
| Intraligamentary Injection Group | Experimental | An intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle. Receives: Device: Intraligamentary Injection Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of anesthesia techniques
Heft-Parker visual analog scale (HPVAS) was used to evaluate the patient's subjective pain and convert it to quantitative values. The pain was classified as follows: 0, no pain as "1"; 1-54 mm, mild pain as "2"; 55-112 mm, moderate pain as "3"; and 114-170 mm, severe pain as "4".
If the VAS value is 1 and 2, anesthesia is considered successful, if 3 and 4, anesthesia is considered unsuccessful.
HPVAS-1 determines the VAS value of pain response to cold test. The VAS value of the pain response at the start of the treatment is HPVAS-2.
The VAS value of the pain response on entering the pulp chamber HPVAS-3:
The VAS value of the pain response during pulp extirpation was recorded as HPVAS-4.
Measured: 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start21 Dec 2021
- Primary completion3 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, DentalStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şehnaz Yilmaz, DDS, PhD, Cukurova University
- Investigators
- Şehnaz Yılmaz, DDS,PhD, Principal investigator, Çukurova University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839093
- Sponsor's protocol ID
- TDH-2020-12818
- Status last verified
- May 2023
- First submitted
- 20 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It has been collected Visual Analog Scale (VAS) forms from the participants as data. Each participants was marked four times from the beginning to the end of the treatment.
Publications
Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.
PubMed 22794202Habib MFOM, Tarek S, Teama SME, Ezzat K, El Boghdadi RM, Marzouk A, Fouda MY, Gawdat SI, Bedier MM, Amin SAW. Inferior alveolar nerve block success of 2% mepivacaine versus 4% articaine in patients with symptomatic irreversible pulpitis in mandibular molars: A randomized double-blind single-centre clinical trial. Int Endod J. 2022 Nov;55(11):1177-1189. doi: 10.1111/iej.13810. Epub 2022 Aug 20.
PubMed 35947082
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Intraligamentary + Buccal Infiltration Anesthesia and Inferior Alveolar Nerve Block + Buccal Infiltration Anesthesia in Symptomatic Mandibular Molars With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05839093
- Acronym / sponsor ID
- TDH-2020-12818
- Conditions
- Anesthesia, Dental
- Keywords
- pain, irreversible pulpitis, intraligamentary injection, inferior alveolar nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 3 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 aim of this clinical study is to evaluate the success of buccal infiltration (BI) anesthesia + intraligamentary (ILI) anesthesia between inferior alveolar nerve block (IANB) anesthesia + buccal infiltration anesthesia in mandibular molar teeth with acute symptomatic irreversible pulpitis.The main questions it aims to answer are:
- Does the anesthesia techniques adequate to perform root canal treatment painlessly?
- Which technique achieved pulpal anesthesia? Participants were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. Then, root canal treatment was performed.
Researchers were compared the success of anesthesia techniques in different stages of root canal treatment.
Detailed description
A total of 50 patients, aged between 18-65, who were diagnosed with symptomatic irreversible pulpitis of the mandibular molar tooth, were included in this study. The patients were allocated in two groups according to the randomization blocks, with a total of 25 patients in each group. In IANB + BI anesthesia techniques, a total of approximately 2.8 ml of anesthetic solution, 1.8 ml + 1 ml, was applied, while for BI + ILI, a total of approximately 1.72 ml, 1 ml + 0.72 ml, was administered. After the anesthesia, a rubber dam was placed on the associated tooth of the patient for root canal treatment, the endodontic access cavity was opened, and canal preparation procedures were started. The pain levels felt by the patients during the endodontic treatment stages (starting the treatment, opening the endodontic access cavity and pulp extirpation) were determined by Heft-Parker VAS (HP-VAS) scale. Anesthesia was considered successful in patients who felt no pain (HP-VAS ratio = 0) or mild pain (HP-VAS ratio ≤ 54) during the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inferior Alveolar Nerve Block Group | Active comparator | Device: Inferior Alveolar Nerve Block GroupA standard Inferior Alveolar Nerve Block (IANB) injection with a conventional dental injector and a 27-G needle to achieve pulpal anesthesia in mandibular molar teeth. |
| Intraligamentary Injection Group | Experimental | Device: Intraligamentary Injection GroupAn intraligamentary injection that performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Systemically healthy patients
- The absence of periapical pathology
- Not sensitive to articaine or epinephrine
- No facial paresthesia
- Not taking any analgesic drug 6 hours before treatment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Inferior Alveolar Nerve Block GroupA standard IANB injection with a conventional dental injector and a 27-G needle. After determining the injection site and performing aspiration, 1.8 mL of solution was injected at a rate of 1 mL/min to block the inferior alveolar nerve. After achieving lip anesthesia, infiltration was performed at the buccal side of the affected tooth with 0.5 mL using a normal syringe and a 27-G needle. The needle insertion point was the middle of the mesiodistal distance of the crown. Five minutes later, the teeth were isolated and the endodontic procedure was started. | Device | Inferior Alveolar Nerve Block Group |
| Intraligamentary Injection GroupAn infiltration was performed at the buccal side of the affected tooth with 0.5 mL using a normal syringe and a 27-G needle. Then, an intraligamentary injection was performed with a special pressure injection syringe (Sopira Citoject, Kulzer, Hanau, Germany) and a 30-G needle. The needle was placed alongside the tooth and inserted at a 30 angle relative to the longitudinal axis of the crown with the needle between the teeth and the bone. Then, in the mesiobuccal, distobuccal, mesiolingual and distolingual portions of teeth, 0.18 mL of the solution was injected. Five minutes later, the teeth were isolated and the endodontic procedure was started. | Device | Intraligamentary Injection Group |
Primary outcome
The success of anesthesia techniques
Time frame: 0-2 hours
Heft-Parker visual analog scale (HPVAS) was used to evaluate the patient's subjective pain and convert it to quantitative values. The pain was classified as follows: 0, no pain as "1"; 1-54 mm, mild pain as "2"; 55-112 mm, moderate pain as "3"; and 114-170 mm, severe pain as "4". If the VAS value is 1 and 2, anesthesia is considered successful, if 3 and 4, anesthesia is considered unsuccessful. HPVAS-1 determines the VAS value of pain response to cold test. The VAS value of the pain response at the start of the treatment is HPVAS-2. The VAS value of the pain response on entering the pulp chamber HPVAS-3: The VAS value of the pain response during pulp extirpation was recorded as HPVAS-4.
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 6 May 2023.
- Background: PubMed 22794202Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.
- Background: PubMed 35947082Habib MFOM, Tarek S, Teama SME, Ezzat K, El Boghdadi RM, Marzouk A, Fouda MY, Gawdat SI, Bedier MM, Amin SAW. Inferior alveolar nerve block success of 2% mepivacaine versus 4% articaine in patients with symptomatic irreversible pulpitis in mandibular molars: A randomized double-blind single-centre clinical trial. Int Endod J. 2022 Nov;55(11):1177-1189. doi: 10.1111/iej.13810. Epub 2022 Aug 20.
- Individual participant dataSharing planned: Yes. It has been collected Visual Analog Scale (VAS) forms from the participants as data. Each participants was marked four times from the beginning to the end of the treatment.
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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.
Şehnaz Yılmaz, DDS,PhD principal investigator
Çukurova University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Alveolar Nerve Block Group and Intraligamentary Injection Group in people with Anesthesia, Dental, run by Cukurova University at 1 site in Turkey (Türkiye).
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 10 inclusion and 1 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 6 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 Turkey (Türkiye). 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?
The success of anesthesia techniques (time frame: 0-2 hours). 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 NCT05839093, which also lists 2 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 6 May 2023.