Tooth ExtractionNCT06611865
Comparison of Intraligamentary Anesthesia With the Inferior Alveolar Nerve Block for the Extraction of Mandibular Molars.
A study testing Intraligamentary anaesthesia and Inferior alveolar nerve block in people with Tooth Extraction and Tooth Extraction Site Healing, run by Hamza Zia Ahmed at 1 site in Pakistan.
Trial summary
Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Tooth Extraction Site Healing
- What is being tested?
- Intraligamentary anaesthesia and Inferior alveolar nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2024to 17 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes who were more than 18 years of age; they had indications of non-surgical extraction of one or multiple mandibular posterior teeth.
Who cannot join
- For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.
- The exclusion criteria for individual teeth were: acutely infected teeth or any teeth with the instances of expression of pus through sinus tracts or the gingival sulcus were excluded. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional Study Documenting the Relative Efficacy of Intraligamentary Anesthesia and the Inferior Alveolar Nerve Block for the Extraction of Posterior Mandibular Teeth.
Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. It will help dentists better understand the benefits of the two techniques, and their usage case to case.
Read the detailed description
The study was designed as a randomized controlled trial. The purpose of this study was to examine the differences in efficacy of the intraligamentary anaesthetic technique and the inferior alveolar nerve block for mandibular posterior tooth extraction cases. Pain intensity, duration of anaesthesia, incidence of post-operative dry socket, success rates, onset of anaesthesia were examined. It was done in a split-mouth method so that two different techniques were used in the same patient, thus minimizing individual variations.
- Conditions
- Tooth Extraction, Tooth Extraction Site Healing
- Being tested
- Intraligamentary anaesthesia, Inferior alveolar nerve block
- Keywords
- Intraligamentary Anaesthesia, Inferior Alveolar Nerve Block, Tooth Extraction, Dry Socket
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraligamentary anaesthesiaProcedure or surgery
Injection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe.
Inferior alveolar nerve blockProcedure or surgery
Anaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point.
| Study group | Role | What they receive |
|---|---|---|
| Split-mouth group | Active comparator | It includes bilaterally indicated teeth. ILA and IANB were used on opposite sides in the same person; the second tooth was anesthetized only after the first extraction had completed and had been recorded. Receives: Procedure: Intraligamentary anaesthesia; Procedure: Inferior alveolar nerve block |
| Group 2 ILA | Active comparator | The patients in group 2, with unilateral extractions, that were only administered Intraligamentary anaesthesia. Receives: Procedure: Intraligamentary anaesthesia |
| Group 2 IANB | Active comparator | The patients in group 2, with unilateral extractions, that were only administered the Inferior Alveolar Nerve Block. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study. Receives: Procedure: Inferior alveolar nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection pain
Rating of injection administration pain from 0-10.
Measured: Through the duration of injection (within a few seconds to 1 minute)
Pain during extraction procedure
Pain during extraction procedure on a scale of 0-10.
Measured: For the duration of treatment (estimated within 1 hour)
Unpleasantness of treatment
A rating of 0-10 for overall discomfort felt by the patient during the treatment.
Measured: For the duration of treatment (estimated within 1 hour)
Latency time of anesthesia (minutes)
The onset of anesthesia after injection
Measured: Anesthesia was tested with a dental probe on the marginal gingiva at: 1) immediately after the injection and 2) every 10 seconds (ILA) / every 30 seconds (IANB) until complete painlessness was achieved.
Anesthetic effect
4 categories: Complete, sufficient, insufficient or no effect.
Measured: For the duration of treatment (estimated within 2 hours)
Amount of anesthetic solution (mL)
The average amount of anaesthetic solution injected per procedure.
Measured: For the duration of treatment (estimated within 1 hour)
Duration of treatment (minutes)
Time in minutes taken from the injection to the complete extraction of tooth.
Measured: For the duration of treatment (estimated up to 1 to 2 hours)
Duration of local numbness (minutes)
Total duration of local numbness reported by the patient
Measured: For the duration of treatment (estimated up to 1 to 2 hours)
Secondary outcomes (1)
Incidence of Dry socket
Dry socket incidence reported by the patient int he recovery period of 14 days
Measured: From the complete extraction of tooth to 14 days after the extraction of tooth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start15 Mar 2024
- Primary completion2 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A split-mouth group was included with 70 teeth extracted from 35 patients. In such cases, involving bilaterally indicated teeth, ILA and IANB were used on opposite sides, but the second tooth was anesthetized only after the first extraction had completed and had been recorded. The second group had 500 patients with unilateral extractions. ILA was compared with IANB in each group separately, and the results in group I were then compared descriptively with those in group II.
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamza Zia Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hamza Zia Ahmed, Nishtar Medical University
- Investigators
- Amjad Bari, MDS, Study chair, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611865
- Sponsor's protocol ID
- 642/NID
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study Documenting the Relative Efficacy of Intraligamentary Anesthesia and the Inferior Alveolar Nerve Block for the Extraction of Posterior Mandibular Teeth.
- ClinicalTrials.gov ID
- NCT06611865
- Acronym / sponsor ID
- 642/NID
- Conditions
- Tooth Extraction, Tooth Extraction Site Healing
- Keywords
- Intraligamentary Anaesthesia, Inferior Alveolar Nerve Block, Tooth Extraction, Dry Socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Hamza Zia AhmedUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 25 Sep 2024 (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.
Local anaesthesia or numbing is done before tooth extraction. This study compares two different methods of numbing molar teeth before extraction. It compares them on the basis of pain during the procedure and on discomfort after the procedure as well. It will help dentists better understand the benefits of the two techniques, and their usage case to case.
Detailed description
The study was designed as a randomized controlled trial. The purpose of this study was to examine the differences in efficacy of the intraligamentary anaesthetic technique and the inferior alveolar nerve block for mandibular posterior tooth extraction cases. Pain intensity, duration of anaesthesia, incidence of post-operative dry socket, success rates, onset of anaesthesia were examined. It was done in a split-mouth method so that two different techniques were used in the same patient, thus minimizing individual variations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A split-mouth group was included with 70 teeth extracted from 35 patients. In such cases, involving bilaterally indicated teeth, ILA and IANB were used on opposite sides, but the second tooth was anesthetized only after the first extraction had completed and had been recorded. The second group had 500 patients with unilateral extractions. ILA was compared with IANB in each group separately, and the results in group I were then compared descriptively with those in group II.
| Arm | Type | Receives |
|---|---|---|
| Split-mouth group | Active comparator | Procedure: Intraligamentary anaesthesia, Procedure: Inferior alveolar nerve blockIt includes bilaterally indicated teeth. ILA and IANB were used on opposite sides in the same person; the second tooth was anesthetized only after the first extraction had completed and had been recorded. |
| Group 2 ILA | Active comparator | Procedure: Intraligamentary anaesthesiaThe patients in group 2, with unilateral extractions, that were only administered Intraligamentary anaesthesia. |
| Group 2 IANB | Active comparator | Procedure: Inferior alveolar nerve blockThe patients in group 2, with unilateral extractions, that were only administered the Inferior Alveolar Nerve Block. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both sexes who were more than 18 years of age; they had indications of non-surgical extraction of one or multiple mandibular posterior teeth.
Key exclusion criteria (2 listed)
- For patients: pregnancy, immunological compromise, systemic conditions requiring special considerations and non-compliance.
- The exclusion criteria for individual teeth were: acutely infected teeth or any teeth with the instances of expression of pus through sinus tracts or the gingival sulcus were excluded. In case of multiple unilaterally indicated teeth that were to be extracted under IANB, only the tooth best fitting all criteria was considered for 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 |
|---|---|---|
| Intraligamentary anaesthesiaInjection of anesthetic solution into the intraligamentary space along the long axis of a tooth root using a pressure syringe. | Procedure or surgery | Group 2 ILA, Split-mouth group |
| Inferior alveolar nerve blockAnaesthetic injection into the pterygomandibular space to block the Inferior alveolar nerve at the mandibular foramen point. | Procedure or surgery | Group 2 IANB, Split-mouth group |
Primary outcome
Injection pain
Time frame: Through the duration of injection (within a few seconds to 1 minute)
Rating of injection administration pain from 0-10.
Pain during extraction procedure
Time frame: For the duration of treatment (estimated within 1 hour)
Pain during extraction procedure on a scale of 0-10.
Unpleasantness of treatment
Time frame: For the duration of treatment (estimated within 1 hour)
A rating of 0-10 for overall discomfort felt by the patient during the treatment.
Latency time of anesthesia (minutes)
Time frame: Anesthesia was tested with a dental probe on the marginal gingiva at: 1) immediately after the injection and 2) every 10 seconds (ILA) / every 30 seconds (IANB) until complete painlessness was achieved.
The onset of anesthesia after injection
Anesthetic effect
Time frame: For the duration of treatment (estimated within 2 hours)
4 categories: Complete, sufficient, insufficient or no effect.
Amount of anesthetic solution (mL)
Time frame: For the duration of treatment (estimated within 1 hour)
The average amount of anaesthetic solution injected per procedure.
Duration of treatment (minutes)
Time frame: For the duration of treatment (estimated up to 1 to 2 hours)
Time in minutes taken from the injection to the complete extraction of tooth.
Duration of local numbness (minutes)
Time frame: For the duration of treatment (estimated up to 1 to 2 hours)
Total duration of local numbness reported by the patient
1 secondary outcome
Incidence of Dry socket
Time frame: From the complete extraction of tooth to 14 days after the extraction of tooth
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 25 Sep 2024.
- 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.
Amjad Bari, MDS study chair
Nishtar Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraligamentary anaesthesia and Inferior alveolar nerve block in people with Tooth Extraction and Tooth Extraction Site Healing, run by Hamza Zia Ahmed 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 1 inclusion and 2 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 25 Sep 2024. 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?
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?
Injection pain (time frame: Through the duration of injection (within a few seconds to 1 minute)). The study lists 8 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 25 Sep 2024.