Procedural PainNCT07771452
A Combined 2% Lidocaine Anesthetic Technique for Mandibular Molar Procedures Without Inferior Alveolar Nerve Block
A study testing Lidocaine 2% with 1:100 000 epinephrine in people with Procedural Pain, run by Herat University at 1 site in Afghanistan.
Trial summary
This prospective single-arm pilot study evaluated the clinical effectiveness of a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for dental procedures involving mandibular molars. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Lidocaine 2% with 1:100 000 epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAfghanistan
- Study dates
- 2 Mar 2025to 1 May 2025
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 16-60 years.
- Patients requiring dental treatment involving mandibular molars.
- Patients requiring local anesthesia for the planned dental procedure.
- Patients able and willing to provide informed consent.
- For participants younger than 18 years, informed consent was obtained from a - parent or legal guardian.
Who cannot join
- Known allergy or hypersensitivity to lidocaine or epinephrine.
- Medical conditions contraindicating the use of lidocaine with epinephrine.
- Presence of acute infection or significant swelling at the injection site.
- Patients unable to cooperate with the dental procedure or assessment of anesthetic effectiveness.
- Patients who declined to participate or provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combined 2% Lidocaine Anesthetic Technique for Mandibular Molar Procedures Without Inferior Alveolar Nerve Block: A Prospective Pilot Study
This prospective single-arm pilot study evaluated the clinical effectiveness of a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for dental procedures involving mandibular molars. The technique combined supraperiosteal, subperiosteal, and periodontal ligament injections and was designed to provide adequate local anesthesia without the use of a conventional inferior alveolar nerve block. Participants requiring restorative, endodontic, extraction, or immediate implant procedures involving mandibular molars received the standardized anesthetic protocol. The primary outcome was successful completion of the planned dental procedure without pain requiring additional conventional nerve block anesthesia. The need for repeat administration and the occurrence of complications were also assessed.
Read the detailed description
This prospective, single-arm pilot study was conducted to evaluate a combined local anesthetic technique for mandibular molar procedures without the use of a conventional inferior alveolar nerve block (IANB). Patients requiring dental treatment involving mandibular molars were enrolled according to predefined eligibility criteria.
Local anesthesia was administered using 2% lidocaine with 1:100,000 epinephrine and a 27-gauge short needle. The standardized technique consisted of three components: supraperiosteal, subperiosteal, and periodontal ligament (PDL) injections. Initially, 0.2 mL of anesthetic solution was administered supraperiosteally, followed by 0.2 mL subperiosteally with deeper needle penetration. PDL anesthesia was then administered on both the mesial and distal aspects of the involved tooth, using 0.5 mL of anesthetic solution at each site.
Anesthetic effectiveness was clinically assessed before and during the planned dental procedure. If adequate anesthesia was not achieved after the initial administration, the combined anesthetic protocol was repeated once. The need for additional conventional inferior alveolar nerve block anesthesia was recorded. Participants were also followed for 48-72 hours to identify any complications associated with the anesthetic technique.
The study included mandibular molars requiring restorative treatment, root canal treatment, extraction, or immediate implant placement. The study was intended to provide preliminary clinical evidence regarding the feasibility and effectiveness of this combined local anesthetic approach and to inform the design of future controlled clinical trials.
- Conditions
- Procedural Pain
- Being tested
- Lidocaine 2% with 1:100 000 epinephrine
- Keywords
- Local Anesthesia, Lidocaine, Mandibular molars, Inferior alveolar nerve block, Periodontal ligament injection, supraperiostal injection, Subperiostal injection
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% with 1:100 000 epinephrineDrug
Local anesthesia was administered using 2% lidocaine with 1:100,000 epinephrine and a 27-gauge short needle. The standardized protocol consisted of 0.2 mL supraperiosteal injection, followed by 0.2 mL subperiosteal injection with deeper needle penetration, and periodontal ligament (PDL) injections of 0.5 mL on the mesial and 0.5 mL on the distal aspect of the mandibular molar. Anesthetic effectiveness was reassessed after 2 minutes. If complete anesthesia was not achieved, the same protocol was repeated once. No inferior alveolar nerve block was administered.
| Study group | Role | What they receive |
|---|---|---|
| Combined local anesthetic technique | Experimental | Participants received a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for mandibular molar procedures. The protocol consisted of supraperiosteal, subperiosteal, and periodontal ligament (PDL) injections. Anesthetic effectiveness was assessed clinically during the planned dental procedure. If complete anesthesia was not achieved after the initial administration, the same anesthetic protocol was repeated once. No conventional inferior alveolar nerve block was used. Receives: Drug: Lidocaine 2% with 1:100 000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Procedural Anesthesia After the First Application
Complete procedural anesthesia was defined as adequate procedure-specific pulpal or periodontal anesthesia permitting completion of the planned dental procedure without pain requiring interruption, repetition of the anesthetic protocol, or rescue anesthesia. Anesthetic adequacy was assessed using thermal testing and cautious test cavity preparation for vital teeth, and periodontal probing and initial tooth manipulation for teeth scheduled for extraction.
Measured: From 2 minutes after completion of the initial anesthetic protocol through completion of the planned dental procedure during the same treatment visit.
Number of Participants With Successful Anesthesia After Initial Administration
Successful anesthesia was defined as completion of the planned dental procedure without pain requiring additional anesthetic administration or conventional inferior alveolar nerve block (IANB) after the initial application of the combined supraperiosteal, subperiosteal, and periodontal ligament (PDL) injection technique.
Measured: During the planned dental procedure, immediately following administration of local anesthesia
Successful anesthesia after initial administration
Successful anesthesia was defined as completion of the planned dental procedure without pain requiring additional anesthetic administration or conventional inferior alveolar nerve block (IANB) after the initial application of the combined supraperiosteal, subperiosteal, and periodontal ligament (PDL) injection technique.
Measured: During the planned dental procedure, immediately following administration of local anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start2 Mar 2025
- Primary completion28 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm pilot study in which all participants received the same combined local anesthetic technique for mandibular molar dental procedures. No control or comparator arm was included.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozair Erfan, Herat University
- Investigators
- Ozair Erfan, Master of Sience, Principal investigator, Stomatology Faculty, Herat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771452
- Sponsor's protocol ID
- ESDC-LA-2025-01
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined 2% Lidocaine Anesthetic Technique for Mandibular Molar Procedures Without Inferior Alveolar Nerve Block: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07771452
- Acronym / sponsor ID
- ESDC-LA-2025-01
- Conditions
- Procedural Pain
- Keywords
- Local Anesthesia, Lidocaine, Mandibular molars, Inferior alveolar nerve block, Periodontal ligament injection, supraperiostal injection, Subperiostal injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Herat UniversityUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 18 Aug 2026 (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.
This prospective single-arm pilot study evaluated the clinical effectiveness of a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for dental procedures involving mandibular molars. The technique combined supraperiosteal, subperiosteal, and periodontal ligament injections and was designed to provide adequate local anesthesia without the use of a conventional inferior alveolar nerve block. Participants requiring restorative, endodontic, extraction, or immediate implant procedures involving mandibular molars received the standardized anesthetic protocol. The primary outcome was successful completion of the planned dental procedure without pain requiring additional conventional nerve block anesthesia. The need for repeat administration and the occurrence of complications were also assessed.
Detailed description
This prospective, single-arm pilot study was conducted to evaluate a combined local anesthetic technique for mandibular molar procedures without the use of a conventional inferior alveolar nerve block (IANB). Patients requiring dental treatment involving mandibular molars were enrolled according to predefined eligibility criteria.
Local anesthesia was administered using 2% lidocaine with 1:100,000 epinephrine and a 27-gauge short needle. The standardized technique consisted of three components: supraperiosteal, subperiosteal, and periodontal ligament (PDL) injections. Initially, 0.2 mL of anesthetic solution was administered supraperiosteally, followed by 0.2 mL subperiosteally with deeper needle penetration. PDL anesthesia was then administered on both the mesial and distal aspects of the involved tooth, using 0.5 mL of anesthetic solution at each site.
Anesthetic effectiveness was clinically assessed before and during the planned dental procedure. If adequate anesthesia was not achieved after the initial administration, the combined anesthetic protocol was repeated once. The need for additional conventional inferior alveolar nerve block anesthesia was recorded. Participants were also followed for 48-72 hours to identify any complications associated with the anesthetic technique.
The study included mandibular molars requiring restorative treatment, root canal treatment, extraction, or immediate implant placement. The study was intended to provide preliminary clinical evidence regarding the feasibility and effectiveness of this combined local anesthetic approach and to inform the design of future controlled clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm pilot study in which all participants received the same combined local anesthetic technique for mandibular molar dental procedures. No control or comparator arm was included.
| Arm | Type | Receives |
|---|---|---|
| Combined local anesthetic technique | Experimental | Drug: Lidocaine 2% with 1:100 000 epinephrineParticipants received a combined local anesthetic technique using 2% lidocaine with 1:100,000 epinephrine for mandibular molar procedures. The protocol consisted of supraperiosteal, subperiosteal, and periodontal ligament (PDL) injections. Anesthetic effectiveness was assessed clinically during the planned dental procedure. If complete anesthesia was not achieved after the initial administration, the same anesthetic protocol was repeated once. No conventional inferior alveolar nerve block was used. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged 16-60 years.
- Patients requiring dental treatment involving mandibular molars.
- Patients requiring local anesthesia for the planned dental procedure.
- Patients able and willing to provide informed consent.
- For participants younger than 18 years, informed consent was obtained from a - parent or legal guardian.
Key exclusion criteria (5 listed)
- Known allergy or hypersensitivity to lidocaine or epinephrine.
- Medical conditions contraindicating the use of lidocaine with epinephrine.
- Presence of acute infection or significant swelling at the injection site.
- Patients unable to cooperate with the dental procedure or assessment of anesthetic effectiveness.
- Patients who declined to participate or provide informed consent.
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 |
|---|---|---|
| Lidocaine 2% with 1:100 000 epinephrineLocal anesthesia was administered using 2% lidocaine with 1:100,000 epinephrine and a 27-gauge short needle. The standardized protocol consisted of 0.2 mL supraperiosteal injection, followed by 0.2 mL subperiosteal injection with deeper needle penetration, and periodontal ligament (PDL) injections of 0.5 mL on the mesial and 0.5 mL on the distal aspect of the mandibular molar. Anesthetic effectiveness was reassessed after 2 minutes. If complete anesthesia was not achieved, the same protocol was repeated once. No inferior alveolar nerve block was administered. | Drug | Combined local anesthetic technique |
Primary outcome
Number of Participants With Complete Procedural Anesthesia After the First Application
Time frame: From 2 minutes after completion of the initial anesthetic protocol through completion of the planned dental procedure during the same treatment visit.
Complete procedural anesthesia was defined as adequate procedure-specific pulpal or periodontal anesthesia permitting completion of the planned dental procedure without pain requiring interruption, repetition of the anesthetic protocol, or rescue anesthesia. Anesthetic adequacy was assessed using thermal testing and cautious test cavity preparation for vital teeth, and periodontal probing and initial tooth manipulation for teeth scheduled for extraction.
Number of Participants With Successful Anesthesia After Initial Administration
Time frame: During the planned dental procedure, immediately following administration of local anesthesia
Successful anesthesia was defined as completion of the planned dental procedure without pain requiring additional anesthetic administration or conventional inferior alveolar nerve block (IANB) after the initial application of the combined supraperiosteal, subperiosteal, and periodontal ligament (PDL) injection technique.
Successful anesthesia after initial administration
Time frame: During the planned dental procedure, immediately following administration of local anesthesia.
Successful anesthesia was defined as completion of the planned dental procedure without pain requiring additional anesthetic administration or conventional inferior alveolar nerve block (IANB) after the initial application of the combined supraperiosteal, subperiosteal, and periodontal ligament (PDL) injection technique.
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
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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.
Ozair Erfan, Master of Sience principal investigator
Stomatology Faculty, Herat 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 Lidocaine 2% with 1:100 000 epinephrine in people with Procedural Pain, run by Herat University at 1 site in Afghanistan.
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: finished, as of the sponsor's last update on 19 Aug 2026. 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 Afghanistan. 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?
Number of Participants With Complete Procedural Anesthesia After the First Application (time frame: From 2 minutes after completion of the initial anesthetic protocol through completion of the planned dental procedure during the same treatment visit.). The study lists 3 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 19 Aug 2026.