A Phase 2 interventional study of Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge in Drug Effect and Pulpitis - Irreversible, sponsored by Armed Forces Institute of Dentistry, Pakistan. Completed at 2 sites in Pakistan. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Armed Forces Institute of Dentistry, Pakistan · Phase 2, Interventional, and Treatment
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
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.
302 studies on the registry are indexed under Pulpitis; 67 are open to participants now.
This study's enrollment of 78 is above the median of 62 across 275 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →Armed Forces Institute of Dentistry, Pakistan is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants in this group will be given 1 cartridge of articaine solution pre-operatively to endodontic treatment
Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
Participants in this group will be given 2 cartridges of articaine solution pre-operatively to endodontic treatment
Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
Local anesthetic injection for intra- operative pain control
Also known as: Orabloc 4% Articaine 1:100,000 1.8 ml
Pain Control
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
Time frame: 30 to 45 minutes
Plan to share: No
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Armed Forces Institute of Dentistry, Pakistan