The Effectiveness of Buccal Infiltration Only Using Articaine for Routine Exodontia of Mandibular Molar: A Cross-Over Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Riyadh Elm University
- Enrollment
- 40
- Primary Endpoint
- Pain measurement
Study Overview
Brief Summary
The goal of this clinical trial, is to test out the efficacy of using Articaine only as a local anesthesia as buccal infiltration to extract lower molar teeth.
Study will be performed in patients visiting Riyadh Elm University clinics seeking extraction of lower molars bilaterally, in each visit one molar tooth will be extracted using Ariticaine and the second visit with Lidocaine, pain level will be monitored and documented.
This study may be helpful in providing scientific information to the oral maxillofacial surgeons which will assist them in choosing the best local anesthetic agent, and possibly substituting using inferior alveolar nerve block with infiltration only when extracting the mandibular posterior teeth.
Detailed Description
This is a double-blind, randomized clinical trial, which will involve 40 patients visiting the out-patient department of Oral and Maxillofacial surgery. For each patient, one mandibular molar will be extracted from right as well as left side, with one side being anesthetized using 4% articaine with 1:100,000 epinephrine and other with 2% lidocaine with 1:100,000 epinephrine buccal infiltration only. Evaluation and comparison will be done on the basis of pain prevalence exhibited by the patients while extraction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
This is a double blinded randomized clinical trial, which neither the injector (investigator) nor the participant will know what anesthesia type was used in each session.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female patients
- •Patients with age more than 18 years
- •Patients indicated for at least one mandibular molar extraction
- •Patients with the ability to fill the questionnaire
Exclusion Criteria
- •Patients with abscess or any lesion, which may affect the local anesthesia provision.
- •Patients with stage III mobile teeth
- •Patients with a history of medical conditions such as diabetes mellitus, heart disease, pregnancy, allergy or renal disease
- •Patients who are not able to give an informed consent or are not agreeing to take part in this study
Arms & Interventions
Right mandibular molar
Articaine 4% with 1:100,000 epinephrine
Intervention: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml (Drug)
Left mandibular molar
Lidocaine 2% with 1:100,000
Intervention: Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml (Drug)
Outcomes
Primary Outcomes
Pain measurement
Time Frame: Pain will be measured after injection, during extraction procedure and at the end of the session immediately after finishing the procedure, scale of pain will be 0 for no pain and 10 for maximum pain
Pain will be measured using the vial analogue scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Albatool Baroom
Resident of Oral & Maxillofacial Surgery in postgraduate program in Riyadh El University
Riyadh Elm University