An interventional study of Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml and Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml in Pain, sponsored by Foundation University Islamabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
The purpose of this study is to check the anesthetic effectiveness of 4% Articaine and 2% Lidocaine in IANB Vs Mental nerve block in 1st and 2nd premolars with symptomatic Irreversible Pulpitis. This study aims to compare and find the best possible anesthetic solution amongst 2% Lidocaine and 4% Articaine and technique ie IANB Vs Mental Nerve block to make endodontic procedure pain free or comfortable for the patient
This study will be including four treatment groups. Conducted as a single blind Randomized control Trial i.e. 2x2 Factorial Design. Primary purpose will be to evaluate the main effect of injection technique , main effect of anesthetic solution and potential interaction between 2 solutions.
This study will be conducted in Department of Operative Dentistry and Endodontics, Foundation University College of dentistry and Hospital , following approval from Institutional Ethical Review committee A total of 108 participants will be recruited. The calculation was based on previously reported anesthetic success rates for MINB and IANB using 2% Lidocaine and 4% Articaine Participants reporting to operative Dentistry department with Symptomatic Irreversible pulpitis in mandibular first and second premolars. Participants meeting inclusion criteria will be invited.
PRE OPERATIVE CLINICAL ASSESMENT will be done i.e. Age , Gender , relevant medical history , Current medications , History of allergies to LA or related components, Any previous anesthesia related events , Intensity of pain before treatment , Presence duration and characteristics of pain. Any condition that may contraindicate the administration of anesthesia Diagnosis of Symptomatic Irreversible pulpitis will be done using a combination of patients history , clinical examination , cold testing and Radiographic evaluation , Pre operative pain assessment using NRS Numerical rating scale from O-10 ADMINSTRATION OF LOCAL ANESTHESIA For MINB groups, 1.8ml of the assigned anesthetic will be deposited in the region of mental foramen after negative aspiration For IANB groups, 1.8ml of the assigned anesthetic will be administered using conventional inferior alveolar nerve block technique after negative aspiration A standardized 15 mins waiting period will be observed after injection. Soft tissue assessment will be done by subjective numbness/probing of buccal gingiva.
PAIN ASSESMENT pain will be recorded using NRS during
PRIMARY OUTCOME
The analysis will evaluate:
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 108 is above the median of 66 across 8,493 interventional studies indexed under Pain.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A will be administered 2% Lidocaine (1: 100,000 epi) using Mental nerve block technique
Procedure: Group A : MINB with 2% Lidocaine HCL+ 1:1000,000 Epinephrine - 1.8 ml
Group B will be administered 4% Articaine (1: 100,000 epi) using Mental nerve block technique
Procedure: Group B : MINB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Group C will be administered 2% lidocaine (1: 100,000 epi) using Inferior Alveolar nerve block technique
Procedure: Group C : IANB with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Group D will be administered 4% Articaine (1: 100,000 epi) using Inferior Alveolar nerve block technique
Procedure: Group D : IANB with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml
Group A will be administered with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml through Mental/Incisive nerve block technique
Group B will be administered with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml through Mental/Incisive nerve block technique
Group C will be administered with 2% Lidocaine HCL + 1:1000,000 Epinephrine - 1.8 ml through Inferior Alveolar nerve block technique
Group D will be administered with 4% Articaine HCL + 1:1000,000 Epinephrine - 1.8 ml through inferior alveolar nerve block
Anesthetic Success Rate
Anesthetic success rate defined as completing access cavity preparation + pulp extirpation with 1. Success : NRS 0-3 ( No pain/ Mild pain) WITHOUT need for supplemental anesthesia 2. Failure : NRS\>3 ( Moderate/Severe pain) requiring supplemental anesthesia
Time frame: Periprocedural and Intraprocedural 1) Preprocedural Assessment of pain on NRS scale (0-10) 2)Intra- Procedural Outcome is Assessed at 15 minutes after giving anesthesia. If no numbness after 15 minutes the patient is excluded from the study.
Pain scores (NRS 0-10) at 4 time points
Pain scores recorded at 4 time points 1. Preoperative pain 2. Pain response to Cold test 3. Pain during access cavity preparation 4. Pain during pulp extirpation
Time frame: Intraoperative
Soft tissue anesthesia success
Presence of soft tissue numbness at 15 mins post-injection assessed by tactile sensation + gentle probing of buccal gingiva
Time frame: Intraoperative
Need for Supplemental Anesthesia
Yes/No and Type : Intra ligamental/Additional block/Buccal Infiltration /Intra pulpal
Time frame: Intraoperative
Complications
Complications after anesthesia can occur like Persistent numbness/Hematoma /Discomfort at injection site /
Time frame: Intraoperative/ Postoperative
Plan to share: Undecided
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