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Not yet recruitingNCT06161714Updated Dec 8, 2023

The Effectiveness of Buccal Infiltration Only Using Articaine for Extraction of Mandibular Molar

A Phase 4 interventional study of Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml in Pain, sponsored by Riyadh Elm University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Riyadh Elm University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Pain
03

In context

Lead sponsor

Riyadh Elm University is the lead sponsor of 24 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Right mandibular molar

    Articaine 4% with 1:100,000 epinephrine

    Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

  • Experimental
    Left mandibular molar

    Lidocaine 2% with 1:100,000

    Drug: Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml

Interventions

  • DrugArticaine 4%/Epi 1:100000 Inj Cart 1.7Ml

    4% articaine with 1:100,000 epinephrine buccal infiltration

    Also known as: Septanest

  • DrugLidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml

    2% Lidocaine with 1:100,000 epinephrine buccal infiltration

    Also known as: Octocaine

06

What researchers measure

Primary outcomes

  1. Pain measurement

    Pain will be measured using the vial analogue scale

    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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Averbuch M, Katzper M. Assessment of visual analog versus categorical scale for measurement of osteoarthritis pain. J Clin Pharmacol. 2004 Apr;44(4):368-72. doi: 10.1177/0091270004263995. PubMed 15051743 ↗
  • Bartlett G, Mansoor J. Articaine buccal infiltration vs lidocaine inferior dental block - a review of the literature. Br Dent J. 2016 Feb 12;220(3):117-20. doi: 10.1038/sj.bdj.2016.93. PubMed 26868800 ↗
  • Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1. PubMed 16320034 ↗
  • Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study. J Endod. 2006 Apr;32(4):296-8. doi: 10.1016/j.joen.2005.09.016. Epub 2006 Feb 17. PubMed 16554198 ↗
  • Majid OW, Muhammad ZA. Effectiveness of Articaine Buccal Infiltration Anesthesia for Mandibular Premolar Extraction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Oral Maxillofac Surg. 2019 Sep;77(9):1784-1789. doi: 10.1016/j.joms.2019.03.033. Epub 2019 Mar 30. PubMed 31028737 ↗
  • Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466. PubMed 28186223 ↗
  • Rathi NV, Khatri AA, Agrawal AG, M SB, Thosar NR, Deolia SG. Anesthetic Efficacy of Buccal Infiltration Articaine versus Lidocaine for Extraction of Primary Molar Teeth. Anesth Prog. 2019 Spring;66(1):3-7. doi: 10.2344/anpr-65-04-02. PubMed 30883236 ↗
  • Rayati F, Noruziha A, Jabbarian R. Efficacy of buccal infiltration anaesthesia with articaine for extraction of mandibular molars: a clinical trial. Br J Oral Maxillofac Surg. 2018 Sep;56(7):607-610. doi: 10.1016/j.bjoms.2018.06.012. Epub 2018 Jul 3. PubMed 29980352 ↗
  • Robertson D, Nusstein J, Reader A, Beck M, McCartney M. The anesthetic efficacy of articaine in buccal infiltration of mandibular posterior teeth. J Am Dent Assoc. 2007 Aug;138(8):1104-12. doi: 10.14219/jada.archive.2007.0324. PubMed 17670879 ↗
  • Soysa NS, Soysa IB, Alles N. Efficacy of articaine vs lignocaine in maxillary and mandibular infiltration and block anesthesia in the dental treatments of adults: A systematic review and meta-analysis. J Investig Clin Dent. 2019 Aug;10(3):e12404. doi: 10.1111/jicd.12404. Epub 2019 Mar 18. PubMed 30887677 ↗
  • Thiem DGE, Schnaith F, Van Aken CME, Kontges A, Kumar VV, Al-Nawas B, Kammerer PW. Extraction of mandibular premolars and molars: comparison between local infiltration via pressure syringe and inferior alveolar nerve block anesthesia. Clin Oral Investig. 2018 Apr;22(3):1523-1530. doi: 10.1007/s00784-017-2251-7. Epub 2017 Oct 17. PubMed 29043507 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06161714
Lead sponsor
Riyadh Elm University
Responsible party
Albatool Baroom (Resident of Oral & Maxillofacial Surgery in postgraduate program in Riyadh El University, Riyadh Elm University) — Principal investigator
First posted
Dec 8, 2023
Start date
Nov 30, 2023 (estimated)
Primary completion
Apr 10, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Dec 8, 2023

Study contacts

Albatool Baroom
Contact
Albatool.a.baroom2021@student.riyadh.edu.sa
+966562600600
Albatool Baroom
principal investigator · Albatool.a.baroom2021@student.riyadh.edu.sa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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