An interventional study of Lidocaine 2% with 1:100 000 epinephrine in Procedural Pain, sponsored by Herat University. Completed at 1 site in Afghanistan. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Herat University · Not applicable, Interventional, and Treatment
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.
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Lidocaine 2% with 1:100 000 epinephrine
Drug page: Lidocaine
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: During the planned dental procedure, immediately following administration of local anesthesia.
Plan to share: No — Individual participant data (IPD) will not be shared because no data-sharing plan was established for this study.
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Studies of the drug tested here: Lidocaine