Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children

NCT05423392 | Completed

• 1 other identifier: 01-18/12-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Optimal anesthesia is an essential requirement for successful dentoalveolar intervention.To achieve this goal,different anesthetic agents and techniques are available. Inferior alveolar nerve block (IANB) remains the most commonly used anesthetic technique. However, after the worldwide approval of articaine, a relatively new local anesthetic with enhanced tissue diffusion properties, many studies on healthy volunteers have investigated the anesthetic efficacy of buccal articaine infiltration and IANB in the mandibular posterior teeth and reported comparable results. Infiltration anesthesia is technically more straightforward, less stressful to the patient, and associated with higher success and lower complication rates than block anesthesia. The aim of this study was to determine the effectiveness of local infiltration anesthesia using 4% articaine in the analgesia of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years.

Conditions

Dental Caries; Primary Teeth; Inferior Alveolar Nerve; Anesthesia, Dental

Keywords

Carticaine; Anesthesia, Dental; Pediatric Dentistry

Outcome Measures

Primary Outcomes (6)

• Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale

  Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale from 0 to 10, where 0 means absence of pain and 10 means unbearable pain.

  during procedure

• Checkout of painlessness in lateral region lower jaw in children using tooth vitality test

  Control and verification of painlessness of the anesthetized lower jaw region will be performed 10 minutes after anesthetic injection using a tooth vitality test.

  10 minutes after anesthetic injection

• Checkout of painlessness in lateral region lower jaw in children using Wong-Baker Pain Rating Scale

  Checkout of painlessness in lateral region lower jaw in children using Wong-Baker Pain Rating Scale from 0 to 10, where 0 means absence of pain and 10 means the strongest possible pain.

  during procedure

• Checkout of painlessness in lateral region lower jaw in children using Frank Behavior Rating Scale

  Checkout of painlessness in lateral region lower jaw in children using Frank Behavior Rating Scale from 0 to 2 , where 0 means cooperating patient and 2 means complete lack of cooperation.

  during procedure

• Checkout of painlessness in lateral region lower jaw in children by determining the development of the roots of permanent teeth

  By determining the growth and development of the roots of permanent premolars and molars by examiner using x-ray before intervention.

  before intervention

• Checkout of painlessness in lateral region lower jaw in children by determining the resorption of the roots of deciduous teeth

  By determining the resorption of the roots of deciduous molars by examiner using x-ray before intervention.

  before intervention

Secondary Outcomes (4)

• Success of indicated dental treatment using tooth vitality test

  10 minutes after dental treatment

• Success of indicated dental treatment using Visual Analog Scale

  immediately after dental treatment

• Success of indicated dental treatment using Wong-Baker Pain Rating Scale

  immediately after dental treatment

• Success of indicated dental treatment using Frank Behavior Rating Scale

  immediately after dental treatment

Other Outcomes (1)

• Success of indicated dental treatment using questionnaire

  15 minutes after dental treatment

Study Arms (2)

The first tasted group using 4% Articaine

EXPERIMENTAL

The group was divided into three subgroups depending on the age of the participials: 1st group from 5-9 years, 2nd from 10-13 years and 3th from 14-18 years. Following placement of 5% lidocaine topical anaesthetic for 3 minutes prior to and at the site of needle penetration, patients were randomly given one of the following local anesthetic regimes administered by the principle investigator. For indicated dental treatment patients would receive 2.0 ml 4% articaine with 1:100,000 epinephrine as a local infiltration in the mucobuccal region,the lateral region of the lower jaw.Criteria for measuring efficacy would be to measure pain during anesthetic injection, 10 minutes after injection,during and after the intervention. The child's behavior would be monitored through all phases of clinical work by direct observation of the dentist( examiner) using the above methodology. After that, the examiner would fill in the questionnaire based on the answer of the child / parent (guardian).

Procedure: Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years; Procedure: Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years; Procedure: Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years

The second tasted group using 2% Lidocaine-chloride

ACTIVE COMPARATOR

The group was divided into three subgroups depending on the age of the participials: 1st group from 5-9 years, 2nd from 10-13 years and 3th from 14-18 years. Following placement of 5% lidocaine topical anesthetic for 3 minutes prior to and at the site of needle penetration, patients were randomly given one of the following local anesthetic regimes administered by the principle investigator. For the indicated dental treatment will be used 2.0 ml 2% lidocaine with 1:80,000 epinephrine as an IANB anesthesia for n.alveolaris inferior. Criteria for measuring efficacy would be to measure pain during anesthetic injection, 10 minutes after injection,during and after the intervention. The child's behavior would be monitored through all phases of clinical work by direct observation of the dentist( examiner) using the above methodology. After that, the examiner would fill in the questionnaire based on the answer of the child / parent (guardian).

Procedure: Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years; Procedure: Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years; Procedure: Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years

Interventions

Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years PROCEDURE

Tooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure.

Also known as: 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chloride

The first tasted group using 4% Articaine; The second tasted group using 2% Lidocaine-chloride

Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years PROCEDURE

Endodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment.

Also known as: 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chloride

The first tasted group using 4% Articaine; The second tasted group using 2% Lidocaine-chloride

Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years PROCEDURE

Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.

Also known as: 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chloride

The first tasted group using 4% Articaine; The second tasted group using 2% Lidocaine-chloride

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Respondents of both sexes, aged 5-18 years
• Subjects in need of either conservative rehabilitation or tooth extraction on deciduous or permanent premolars and / or molars
• Subjects who have an X-ray of the teeth for the need of dental rehabilitation

You may not qualify if:

• difficult cooperation with the patient
• existence of allergy to local anesthetic
• the existence of a diagnosed general disease
• unsigned informative consent

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (15)

• Majid OW, Ahmed AM. The Anesthetic Efficacy of Articaine and Lidocaine in Equivalent Doses as Buccal and Non-Palatal Infiltration for Maxillary Molar Extraction: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. J Oral Maxillofac Surg. 2018 Apr;76(4):737-743. doi: 10.1016/j.joms.2017.11.028. Epub 2017 Nov 27.

  PMID: 29257943 RESULT

• Malamed SF, Handbook of Local Anaesthesia, 4th ed. St. Louis: Mosby-Year Book; 1997. pp. 63-64.

  RESULT

• Peedikayil FC, Vijayan A. An update on local anesthesia for pediatric dental patients. Anesth Essays Res. 2013 Jan-Apr;7(1):4-9. doi: 10.4103/0259-1162.113977.

  PMID: 25885712 RESULT

• Alzahrani F, Duggal MS, Munyombwe T, Tahmassebi JF. Anaesthetic efficacy of 4% articaine and 2% lidocaine for extraction and pulpotomy of mandibular primary molars: an equivalence parallel prospective randomized controlled trial. Int J Paediatr Dent. 2018 May;28(3):335-344. doi: 10.1111/ipd.12361. Epub 2018 Mar 24.

  PMID: 29573375 RESULT

• Arrow P. A comparison of articaine 4% and lignocaine 2% in block and infiltration analgesia in children. Aust Dent J. 2012 Sep;57(3):325-33. doi: 10.1111/j.1834-7819.2012.01699.x. Epub 2012 May 28.

  PMID: 22924356 RESULT

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 RESULT

• Hockenberry MJ, Wilson D, Winkelstein ML. Wongs Essentials of Pediatric Nursing. 7th end. St Louis: Mosby, 2005: 1259.

  RESULT

• Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.

  PMID: 20921070 RESULT

• Champion GD, Goodenough B, von Baeyer CL, Thomas W. Measurement of Pain in Infants and Children, Progress in Pain Research and Management , vol 10. Seattle: IASP Press, 1998: 123-160.

  RESULT

• Meechan JG. The use of the mandibular infiltration anesthetic technique in adults. J Am Dent Assoc. 2011 Sep;142 Suppl 3:19S-24S. doi: 10.14219/jada.archive.2011.0343.

  PMID: 21881058 RESULT

• Oulis CJ, Vadiakas GP, Vasilopoulou A. The effectiveness of mandibular infiltration compared to mandibular block anesthesia in treating primary molars in children. Pediatr Dent. 1996 Jul-Aug;18(4):301-5.

  PMID: 8857658 RESULT

• Jung IY, Kim JH, Kim ES, Lee CY, Lee SJ. An evaluation of buccal infiltrations and inferior alveolar nerve blocks in pulpal anesthesia for mandibular first molars. J Endod. 2008 Jan;34(1):11-3. doi: 10.1016/j.joen.2007.09.006.

  PMID: 18155484 RESULT

• Corbett IP, Kanaa MD, Whitworth JM, Meechan JG. Articaine infiltration for anesthesia of mandibular first molars. J Endod. 2008 May;34(5):514-8. doi: 10.1016/j.joen.2008.02.042.

  PMID: 18436027 RESULT

• Srinivasan MR, Poorni S, Nitharshika Y, et al: Articaine buccal infiltration versus lignocaine inferior alveolar block for pulpal anesthesia in mandibular second premolars-Randomized control double blinded clinical trial. J Pierre Fauchard Acad 31:79, 2017

  RESULT

• Meechan JG. Infiltration anesthesia in the mandible. Dent Clin North Am. 2010 Oct;54(4):621-9. doi: 10.1016/j.cden.2010.06.003.

  PMID: 20831926 RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

Carticaine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Branislav V Bajkin, DMD, PhD

  Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

  STUDY CHAIR

• Jelena Komšić, DMD

  Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly and equally assigned to treatment groups. The study was planned as a double-blind. Thus, neither the patients nor the researchers knew which anesthetic will be applied. Only practioner, who will injected anesthetic will know what tipe of anesthetic is it - 4% articain or 2% lidocain chlorid. Number of participials is 60, divided into two equal groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMD, PhD, Full Professor

Model Details: A RANDOMIZED DOUBLE BLIND

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: June 21, 2022
• Study Start: December 2, 2021
• Primary Completion: January 31, 2023
• Study Completion: February 1, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)