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

NCT ID: NCT06161714

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2024-04-30

Brief Summary

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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

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Right mandibular molar

Articaine 4% with 1:100,000 epinephrine

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Left mandibular molar

Lidocaine 2% with 1:100,000

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Other Intervention Names

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Septanest Octocaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riyadh Elm University

OTHER

Sponsor Role lead

Responsible Party

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Albatool Baroom

Resident of Oral & Maxillofacial Surgery in postgraduate program in Riyadh El University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albatool Baroom

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Central Contacts

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Albatool Baroom

Role: CONTACT

Phone: +966562600600

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 15051743 (View on PubMed)

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.

Reference Type RESULT
PMID: 26868800 (View on PubMed)

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.

Reference Type RESULT
PMID: 16320034 (View on PubMed)

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.

Reference Type RESULT
PMID: 16554198 (View on PubMed)

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.

Reference Type RESULT
PMID: 31028737 (View on PubMed)

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.

Reference Type RESULT
PMID: 28186223 (View on PubMed)

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.

Reference Type RESULT
PMID: 30883236 (View on PubMed)

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.

Reference Type RESULT
PMID: 29980352 (View on PubMed)

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.

Reference Type RESULT
PMID: 17670879 (View on PubMed)

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.

Reference Type RESULT
PMID: 30887677 (View on PubMed)

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.

Reference Type RESULT
PMID: 29043507 (View on PubMed)

Other Identifiers

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FPGRP/2023/791/1041

Identifier Type: -

Identifier Source: org_study_id