Dental CariesNCT05423392
Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children
A study testing Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years and Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years in people with Dental Caries and Primary Teeth, run by University of Novi Sad at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Dental Caries, Primary Teeth, Inferior Alveolar Nerve
- What is being tested?
- Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years and Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- 2 Dec 2021to 1 Feb 2023
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- difficult cooperation with the patient
- existence of allergy to local anesthetic
- the existence of a diagnosed general disease
- unsigned informative consent
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
Novi Sad, Vojvodina, 21000
About this study
Official title: Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children: A Double-blind Randomized Study
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.
Read the detailed 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:
- Visual Analog Scales (VAS)
- Tooth vitality test
- Wong-Baker Pain Rating Scale (W-BFSR)
- Frank Behavior Rating Scale (FBRS)
- By determining the growth and development of the roots of permanent premolars and molars
- 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.
- Being tested
- Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years
- Keywords
- Carticaine, Anesthesia, Dental, Pediatric Dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 yearsProcedure or surgery
Also called 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chloride
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 yearsProcedure or surgery
Also called 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chloride
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 yearsProcedure or surgery
Also called 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chloride
Conservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before intervention
Secondary outcomes (4)
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.
Measured: 10 minutes after dental treatment
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.
Measured: immediately after dental treatment
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.
Measured: immediately after dental treatment
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.
Measured: immediately after dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start2 Dec 2021
- Primary completion31 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A RANDOMIZED DOUBLE BLIND
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Branislav Bajkin, University of Novi Sad
- Investigators
- Branislav V Bajkin, DMD, PhD, Study chair, Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi SadJelena Komšić, DMD, Study director, Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423392
- Sponsor's protocol ID
- 01-18/12-2020
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29257943Malamed SF, Handbook of Local Anaesthesia, 4th ed. St. Louis: Mosby-Year Book; 1997. pp. 63-64.
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.
PubMed 25885712Alzahrani 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.
PubMed 29573375Arrow 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.
PubMed 22924356Bijur 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.
PubMed 11733293Hockenberry MJ, Wilson D, Winkelstein ML. Wongs Essentials of Pediatric Nursing. 7th end. St Louis: Mosby, 2005: 1259.
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.
PubMed 20921070Champion 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.
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.
PubMed 21881058Oulis 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.
PubMed 8857658Jung 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.
PubMed 18155484Corbett 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.
PubMed 18436027Srinivasan 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
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.
PubMed 20831926
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 4% Articaine Terminal Anesthesia in the Lateral Jaw Region in Children: A Double-blind Randomized Study
- ClinicalTrials.gov ID
- NCT05423392
- Acronym / sponsor ID
- 01-18/12-2020
- Keywords
- Carticaine, Anesthesia, Dental, Pediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Novi SadUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Visual Analog Scales (VAS)
- Tooth vitality test
- Wong-Baker Pain Rating Scale (W-BFSR)
- Frank Behavior Rating Scale (FBRS)
- By determining the growth and development of the roots of permanent premolars and molars
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A RANDOMIZED DOUBLE BLIND
| Arm | Type | Receives |
|---|---|---|
| The first tasted group using 4% Articaine | Experimental | 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 yearsThe 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). |
| The second tasted group using 2% Lidocaine-chloride | Active comparator | 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 yearsThe 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). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- difficult cooperation with the patient
- existence of allergy to local anesthetic
- the existence of a diagnosed general disease
- unsigned informative consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 yearsAlso: 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chlorideTooth extraction will be following up with the methodological procedures in order to define the effectiveness of anesthetics during indicated dental procedure. | Procedure or surgery | 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 yearsAlso: 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chlorideEndodontic dental treatment will be following up with the methodological procedures in order to define the effectiveness of anesthetics during dental treatment. | Procedure or surgery | 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 yearsAlso: 4% Articaine, Effectiveness of anesthetics, Lateral jaw region in children, 2% Lidocaine-chlorideConservative tooth restoration will be following up with the methodological procedures in order to define the effectiveness of anesthetics during conservative tooth restoration. | Procedure or surgery | The first tasted group using 4% Articaine, The second tasted group using 2% Lidocaine-chloride |
Primary outcome
Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale
Time frame: during procedure
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.
Checkout of painlessness in lateral region lower jaw in children using tooth vitality test
Time frame: 10 minutes after anesthetic injection
Control and verification of painlessness of the anesthetized lower jaw region will be performed 10 minutes after anesthetic injection using a tooth vitality test.
Checkout of painlessness in lateral region lower jaw in children using Wong-Baker Pain Rating Scale
Time frame: during procedure
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.
Checkout of painlessness in lateral region lower jaw in children using Frank Behavior Rating Scale
Time frame: during procedure
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.
Checkout of painlessness in lateral region lower jaw in children by determining the development of the roots of permanent teeth
Time frame: before intervention
By determining the growth and development of the roots of permanent premolars and molars by examiner using x-ray before intervention.
Checkout of painlessness in lateral region lower jaw in children by determining the resorption of the roots of deciduous teeth
Time frame: before intervention
By determining the resorption of the roots of deciduous molars by examiner using x-ray before intervention.
4 secondary outcomes
Success of indicated dental treatment using tooth vitality test
Time frame: 10 minutes after dental treatment
Success of indicated dental treatment using Visual Analog Scale
Time frame: immediately after dental treatment
Success of indicated dental treatment using Wong-Baker Pain Rating Scale
Time frame: immediately after dental treatment
Success of indicated dental treatment using Frank Behavior Rating Scale
Time frame: immediately after dental treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Results publication: PubMed 29257943Majid 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.
- Results publicationMalamed SF, Handbook of Local Anaesthesia, 4th ed. St. Louis: Mosby-Year Book; 1997. pp. 63-64.
- Results publication: PubMed 25885712Peedikayil 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.
- Results publication: PubMed 29573375Alzahrani 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.
- Results publication: PubMed 22924356Arrow 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.
- Results publication: PubMed 11733293Bijur 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.
- Results publicationHockenberry MJ, Wilson D, Winkelstein ML. Wongs Essentials of Pediatric Nursing. 7th end. St Louis: Mosby, 2005: 1259.
- Results publication: PubMed 20921070Tomlinson 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.
- Results publicationChampion 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.
- Results publication: PubMed 21881058Meechan 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.
- Results publication: PubMed 8857658Oulis 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.
- Results publication: PubMed 18155484Jung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branislav V Bajkin, DMD, PhD study chair
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
Jelena Komšić, DMD study director
Dental Clinic of Vojvodina, Faculty of Medicine, University of Novi Sad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years, Endodontic dental treatment of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years and Conservative tooth restoration of deciduous and permanent molars in children aged 5-18 years and mandibular premolars in children aged 10-18 years in people with Dental Caries and Primary Teeth, run by University of Novi Sad at 1 site in Serbia.
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 3 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: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Checkout of painlessness in lateral region lower jaw in children using Visual Analog Scale (time frame: during procedure). The study lists 6 primary outcomes in all. 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 NCT05423392, which also lists 15 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 1 Feb 2023.