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AzTrials

PainPhase 4NCT06161714

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

A Phase 4 study testing Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml in people with Pain, run by Riyadh Elm University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
30 Nov 2023to 30 Apr 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Albatool Baroom contact

+966562600600

Albatool.a.baroom2021@student.riyadh.edu.sa

About this study

Official title: The Effectiveness of Buccal Infiltration Only Using Articaine for Routine Exodontia of Mandibular Molar: A Cross-Over Randomized Controlled Clinical Trial

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.

Conditions
Pain
Being tested
Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml, Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Articaine 4%/Epi 1:100000 Inj Cart 1.7MlDrug

    Also called Septanest

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

  • Lidocaine 2%/Epi 1:100000 Inj Cart 1.7MlDrug

    Also called Octocaine

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

Study groups in NCT06161714
Study groupRoleWhat they receive
Right mandibular molarExperimentalArticaine 4% with 1:100,000 epinephrine
Receives: Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml
Left mandibular molarExperimentalLidocaine 2% with 1:100,000
Receives: Drug: Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain measurement

    Pain will be measured using the vial analogue scale

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start30 Nov 2023 (estimated)
  3. Primary completion10 Apr 2024 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
One 1.8 ml cartridge of 4% articaine with 1:100,000 epinephrine will be utilized in the articaine group and one 1.8 ml cartridge of 2% lidocaine with 1:100,000 epinephrine will be utilized in the lidocaine group. The cartridges will be of similar size and shape, to be allotted a special code, enclosed in thin, adhesive tape by the distributor, and kept into one box for articaine and another box for lidocaine. A 27-gauge needle will be used for buccal infiltration in each case. Any sensation of pain after administering the local anesthesia will be considered as a failure and an inferior alveolar nerve block will be given. Otherwise, the tooth will be extracted with no additional anesthesia.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161714
Sponsor's protocol ID
FPGRP/2023/791/1041
Status last verified
Dec 2023
First submitted
25 Nov 2023
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml and Lidocaine 2%/Epi 1:100000 Inj Cart 1.7Ml in people with Pain, run by Riyadh Elm University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Albatool Baroom (+966562600600, Albatool.a.baroom2021@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06161714, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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