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

Dental Caries Clinical Trial

Official title:

Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children: A Double-blind Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423392
• Other study ID #: 01-18/12-2020
• Status: Completed
• Phase: N/A
• Start date: December 2, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2023
• Source: University of Novi Sad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Clinical study to evaluate the effectiveness of local anesthesia with 4% articaine in order to ensure painless and effective implementation of dental procedures in children. Selection of respondents: participians with good systemic health - patients classified as American Society of Anesthesiologists (ASA) classification - ASA I and ASA II will be included in the study and required invasive dental treatment using local anesthetic (restoration or extraction) on deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, over 20 kg of body weight.The research would include at least 60 participials aged 5-18, who would be divided into two groups. One group the local anesthetic 4% articaine would be used. The second group would be provided with the local anesthetic 2% lidocaine chloride, as a control group. Analysis and data collection in each group would create subgroups depending on the age of the participials: 5-9 years, 10-13 years and 14-18 years.A clinical study would be doubly blind. Participials who would be included in the clinical study would sign a consent form to participate in the clinical study but would not know which anesthetic would be received.Criteria for measuring efficacy would be to measure pain during anesthetic injection,10 minutes after injection, and during and after the intervention using:

1. Visual Analog Scales (VAS)

2. Tooth vitality test

3. Wong-Baker Pain Rating Scale (W-BFSR)

4. Frank Behavior Rating Scale (FBRS)

5. By determining the growth and development of the roots of permanent premolars and molars

6. By determining the resorption of the roots of deciduous molars.

The child's behavior would be monitored through all phases of clinical work by direct observation of the dentist(examiner) who is in charge of measuring the effectiveness of anesthetics but does not know what type of anesthetic. Only a dentist who applies(practitioner) an anesthetic will know what type of anesthetic it is. After that, the examiner would fill in the questionnaire based on the answer of the child / parent (guardian).

In accordance with known ethical principles and in accordance with the principles of Good Clinical Practice (GCP), care for the well-being of the patients was maximally respected, in accordance with the latest revision of the Declaration of Helsinki and accepted principles that apply to clinical trials on humans. The holder of the protection of the patients in this clinical trial is the principal researcher, who cooperated with the Ethics Committee of the Dental Clinic of Vojvodina, University of Novi Sad. The patients written Informed Consent implied that the patient had received full information about the research, and was stressed that they had the right to decide independently to participate, without coercion and external influences, or any harmful consequences if they refused to participate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• difficult cooperation with the patient

• existence of allergy to local anesthetic

• the existence of a diagnosed general disease

• unsigned informative consent

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
Tooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure.
• Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
Endodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment.
• Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.

Locations

Country	Name	City	State
Serbia	Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

References & Publications (15)

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 — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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

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. — View Citation

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 — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, 201

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Success of indicated dental treatment using questionnaire	The examiner would fill in a questionnaire ( The guestionnaire for the child / parent (guardian)) wich contains 10 questions with YES or NO answers about the dental procedure and the success of the indicated treatment based on children's responses. Five and more positive answers of ten questions support the positive outcome.	15 minutes after dental treatment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Success of indicated dental treatment using tooth vitality test	The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using tooth vitality test 10 minutes after dental treatment.	10 minutes after dental treatment
Secondary	Success of indicated dental treatment using Visual Analog Scale	The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using Visual Analog Scale from 0 to 10, where 0 means absence of pain and 10 means unbearable pain.	immediately after dental treatment
Secondary	Success of indicated dental treatment using Wong-Baker Pain Rating Scale	The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using Wong-Baker Pain Rating Scale from 0 to 10, where 0 means absence of pain and 10 means the strongest possible pain.	immediately after dental treatment
Secondary	Success of indicated dental treatment using Frank Behavior Rating Scale	The success and effectiveness of anesthetics will be determined immediately after the completion of the indicated dental treatment using Frank Behavior Rating Scale from 0 to 2 , where 0 means cooperating patient and 2 means complete lack of cooperation.	immediately after dental treatment