Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
DrugLocal anesthetic injection for intra- operative pain control
Other names: Orabloc 4% Articaine 1:100,000 1.8 ml
NCT Number: NCT05840913
This is a randomized controlled trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 2
Armed Forces Institue Of Dentistry, Rawalpindi, Punjab Province, Pakistan
An informed written consent of the patients will be obtained. (Annex-A).
Demographic details (including name, age, gender, contact) will be obtained on data collection forms. (Annex-B).
The principal investigator will perform the local anesthetic injection and the participants will be assigned to one of the groups.
Group 1: 1.8 mL articaine Group 2: 3.6 mL articaine
Before starting the treatment i.e. before administration of the anesthetic solution, each participant will receive an explanation regarding the Heft-Parker visual analog pain scale (VAS) and asked to rate their pain on a self-report questionnaire.
A topical anesthetic gel (20% Benzocaine; Premier, Philadelphia, PA) will passively placed at the injection site with a cotton tip applicator for 1 minute before injection.
A conventional IANB will administered using an aspirating syringe with a side-loading cartridge system (Dena Instruments; Forgeman Instruments Co, Sialkot, Pakistan) and a 27-G 31-mm needle (C-K ject; CK Dental, Kor-Kyungji-do, Korea).
All injections will be given by one clinician in both groups. Group 2 participants will receive 2 cartridges of the anesthetic solution and group 1 will receive a cartridge of the anesthetic solution followed by a mock injection.
The rest of the procedure will be performed by a second investigator. Ten minutes after injection, the participants will be asked whether they have lip numbness. Any patient without lip numbness at this stage will excluded from study.
Fifteen minutes after the administration of the IANB, the teeth will be re-evaluated with electric pulp testing. On positive response, participants will be again asked to rate their pain using the VAS on the questionnaire.
If higher than mild pain is reported, supplemental anesthesia (intraperiodontal ligament or intrapulpal injection) will be used to provide patient comfort throughout the treatment.
Then teeth under study will be isolated with a rubber dam, and caries removed followed by the preparation of an endodontic access cavity. The participants will be informed to stop the practitioner at any stage of treatment if they feel more than mild pain by raising their hand.
At the end of each stage of treatment (access cavity preparation, pulp chamber opening, root canal instrumentation), the practitioner will stop work and ask the participants to rate their pain if they do not raise their hand during treatment.
The success will be defined as the ability to undertake pulp access and canal instrumentation with no or mild pain whereas moderate or severe pain will considered as failure of anesthesia.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Local anesthetic injection for intra- operative pain control
Other names: Orabloc 4% Articaine 1:100,000 1.8 ml
Time frame: 30 to 45 minutes
Pain was recorded on a self-report questionnaire using the visual analog pain scale (VAS) VAS was used for gauging pain before the administration of the anesthetic solution, after the cold test was performed, and during the endodontic therapy.
The VAS scores were designated as; 0= no pain 1-3= mild pain 4-7= moderate pain 8-10= severe pain
Armed Forces Institute of Dentistry, Pakistan
Other
Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth with Symptomatic Irreversible Pulpitis
Acronym: IANB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05335915
Chemically-Induced Disorders, Drug Effect
Baltimore, Maryland, United States
View Trial DetailsNCT05796362
Clinical Infection, Communicable Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT04387201
Adiposity, Body Weight
Houston, Texas, United States
View Trial DetailsNCT05300152
Drug Effect
Ismailia, Egypt
View Trial Details