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Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

Primary Purpose

Dental Pain, Anesthesia, Local

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Articaine
Sponsored by
Universidade Federal de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pain focused on measuring articaine, lidocaine, child, pain

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical criteria: the presence of coronary destruction precluding restoration or adequate use of absolute isolation for endodontic and restorative procedures; perforation of the pulp chamber floor.
  • Radiographic criteria: deciduous molars with at least one non-resorbed half-length root presenting carious lesions or defective restorations associated with signs or symptoms suggestive of pulp necrosis with endodontic contraindication (periapical or interradicular lesion extending over more than half of the roots or involving the crypt of the permanent successor tooth; the presence of pathologic resorption of more than 1/3 of one or more roots; failure of endodontic treatment with the persistence of periapical or inter-radicular lesion with or without clinical signs and symptoms; internal resorption).

Exclusion Criteria:

  • Participants with acute pain or presence of odontogenic infection associated with systemic signs and symptoms and in cases of urgency;
  • History of bleeding or blood clotting problems or taking medications that alter blood clotting prior to the procedure;
  • Hypersensitivity or history of allergy to the drugs used in the research;
  • Asthma;
  • History of liver disease;
  • History of sulfite allergy;
  • Report of post-traumatic stress disorders or recurrent hospitalizations, personality or anxiety disorders, diagnosis of phobias or definite uncooperative behavior;
  • Neurological disorders or communication difficulties;
  • Use of analgesic or anti-inflammatory medications up to 5 hours before the procedure;
  • Parents or guardians unable to be available for follow-up and/or respond to information necessary for the survey within 24 hours of the procedure.

Sites / Locations

  • Centro de Especialidades Odontológicas (CEO)Recruiting
  • Centro de Especialidades Odontológicas (CEO)Recruiting
  • Universidade Federal de Santa Catarina - USFCRecruiting
  • Centro de Especialidades Odontológicas (CEO)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lidocaine

Articaine

Arm Description

Forty-eight (48) children will receive conventional infiltration anesthesia (buccal infiltration injection followed by complementary injections on the palatal region) with 2% lidocaine and 1:100,000 epinephrine at a dose previously calculated by weight. Two-thirds of the anesthetic will be injected into the buccal area and 1/3 into the palatal area. Other Names: Control Group

Forty-eight (48) children will receive a single buccal infiltration injection with 4% articaine and 1:100,000 epinephrine at a dose previously calculated by weight. Other Names: Test Group

Outcomes

Primary Outcome Measures

Dental Pain
Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)

Secondary Outcome Measures

Full Information

First Posted
June 29, 2022
Last Updated
July 8, 2022
Sponsor
Universidade Federal de Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT05443009
Brief Title
Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction
Official Title
Evaluation of Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction: Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to analyze the effectiveness of articaine in controlling self-reported pain compared with conventional lidocaine anesthesia in children requiring extraction of deciduous maxillary molars. Only one extraction will be performed on each child. At least two consultations will be necessary to carry out the present controlled, randomized, and blinded study. All participants will be treated by the same dentist. Self-reported pain will be assessed using the Visual Analogue Scale.
Detailed Description
In the present study, self-reported pain during extraction of a maxillary primary molar with one buccal infiltration anesthesia with articaine will be compared with the conventional technique (buccal infiltration and palatal supplementation) with lidocaine. The study design will be a blind, controlled, randomized, non-inferiority clinical trial with two parallel groups. The anesthetic will be administered according to the weight of the child, using a table with the amount of anesthetic per weight group and the maximum recommended dose as reference. The hypothesis is that articaine, due to its anesthetic properties, is able to anesthetize as well as lidocaine with only one oral infiltration, without the need for additional anesthesia, which may guarantee better participant comfort, less dental anxiety, and less chair time. The use of the Visual Analogue Scale is important to assess the pain perceived by the children and to ensure the reliability of the responses. Participant comfort will be evaluated at each stage of the proposed treatment, and withdrawal from participation will be guaranteed at any time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain, Anesthesia, Local
Keywords
articaine, lidocaine, child, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A blind, controlled, randomized, non-inferiority clinical trial with two parallel groups with allocation ratio will be 1:1
Masking
Outcomes Assessor
Masking Description
The evaluator will not know to which group the child belongs (anesthetic to be used), nor will he or she see the label of the anesthetic. He or she will be in the room during the initial anesthetic infiltration. All children will be considered participants in the control group, to conceal the anesthetic to be used. The evaluator will be asked to leave the room for as long as necessary to prevent learning whether or not the child receives an additional anesthetic.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Forty-eight (48) children will receive conventional infiltration anesthesia (buccal infiltration injection followed by complementary injections on the palatal region) with 2% lidocaine and 1:100,000 epinephrine at a dose previously calculated by weight. Two-thirds of the anesthetic will be injected into the buccal area and 1/3 into the palatal area. Other Names: Control Group
Arm Title
Articaine
Arm Type
Experimental
Arm Description
Forty-eight (48) children will receive a single buccal infiltration injection with 4% articaine and 1:100,000 epinephrine at a dose previously calculated by weight. Other Names: Test Group
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Control Grup
Intervention Description
A buccal infiltration injection followed by palatal injections and interpapillary injections of 2% lidocaine with 1:100,000 epinephrine will be administered.
Intervention Type
Drug
Intervention Name(s)
Articaine
Other Intervention Name(s)
Test Grup
Intervention Description
A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.
Primary Outcome Measure Information:
Title
Dental Pain
Description
Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)
Time Frame
Immediately after the maxillary primary molar extraction
Other Pre-specified Outcome Measures:
Title
Dental Pain
Description
Pain is evaluated by the outcome assessor using the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale (FLACC 0-10 score, higher values represent a worse outcome) and the Faces Pain Scale - Revised (FBRS 0-10 score, higher values represent a worse outcome)
Time Frame
During the injection of local anesthesia and the surgical procedure
Title
Dental Pain
Description
Self-assessment of pain using the Wong-Baker FACES Pain Rating Scale (FACES 0-10 score, higher values represent a worse outcome)
Time Frame
Immediately after the injection of local anesthesia and the maxillary primary molar extraction
Title
Dental Pain
Description
Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)
Time Frame
Immediately after the injection of local anesthesia
Title
Heart rate variability
Description
Heart rate variability to be verified and recorded with the heart rate sensor (Polar H-10)
Time Frame
Immediately before, durin, and immediately after the surgical procedure
Title
Heart rate
Description
Heart rate to be verified and recorded at moments described above carried out with the heart rate sensor (Polar H-10) and pulse oximeter
Time Frame
Immediately before, durin, and immediately after the surgical procedure
Title
Evaluation of Post-surgical Pain
Description
Self-assessment of pain using a Visual Analogue Scale (VAS 0-100 mm, higher values represent a worse outcome) and the Faces Pain Scale - Revised (FBRS 0-10 score, higher values represent a worse outcome) in the postoperative period. It will be applied through teleconsultation
Time Frame
24 hours after the surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical criteria: the presence of coronary destruction precluding restoration or adequate use of absolute isolation for endodontic and restorative procedures; perforation of the pulp chamber floor. Radiographic criteria: deciduous molars with at least one non-resorbed half-length root presenting carious lesions or defective restorations associated with signs or symptoms suggestive of pulp necrosis with endodontic contraindication (periapical or interradicular lesion extending over more than half of the roots or involving the crypt of the permanent successor tooth; the presence of pathologic resorption of more than 1/3 of one or more roots; failure of endodontic treatment with the persistence of periapical or inter-radicular lesion with or without clinical signs and symptoms; internal resorption). Exclusion Criteria: Participants with acute pain or presence of odontogenic infection associated with systemic signs and symptoms and in cases of urgency; History of bleeding or blood clotting problems or taking medications that alter blood clotting prior to the procedure; Hypersensitivity or history of allergy to the drugs used in the research; Asthma; History of liver disease; History of sulfite allergy; Report of post-traumatic stress disorders or recurrent hospitalizations, personality or anxiety disorders, diagnosis of phobias or definite uncooperative behavior; Neurological disorders or communication difficulties; Use of analgesic or anti-inflammatory medications up to 5 hours before the procedure; Parents or guardians unable to be available for follow-up and/or respond to information necessary for the survey within 24 hours of the procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Rigo, MSc.
Phone
+5548998299559
Email
dani-riggo@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariane Cardoso, PhD
Organizational Affiliation
Universidade Federal de Santa Catarina - UFSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carla Santana, PhD
Organizational Affiliation
Universidade Federal de Santa Catarina - UFSC
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Especialidades Odontológicas (CEO)
City
Florianópolis
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marynes Reibnitz, M.Sc
First Name & Middle Initial & Last Name & Degree
Danielle Rigo
First Name & Middle Initial & Last Name & Degree
Aurélio Rocha
First Name & Middle Initial & Last Name & Degree
Pablo Santos
First Name & Middle Initial & Last Name & Degree
Barbara Moccelini
Facility Name
Centro de Especialidades Odontológicas (CEO)
City
Palhoça
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suelen Pagliari
First Name & Middle Initial & Last Name & Degree
Danielle Rigo
First Name & Middle Initial & Last Name & Degree
Aurélio Rocha
First Name & Middle Initial & Last Name & Degree
Pablo Santos
First Name & Middle Initial & Last Name & Degree
Barbara Moccelini
Facility Name
Universidade Federal de Santa Catarina - USFC
City
Santa Catarina
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cardoso Mariane, PhD
First Name & Middle Initial & Last Name & Degree
Danielle Rigo
First Name & Middle Initial & Last Name & Degree
Aurélio Rocha
First Name & Middle Initial & Last Name & Degree
Pablo Santos
First Name & Middle Initial & Last Name & Degree
Barbara Moccelini
Facility Name
Centro de Especialidades Odontológicas (CEO)
City
São José
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaíne da Luz, M.Sc
First Name & Middle Initial & Last Name & Degree
Danielle Rigo
First Name & Middle Initial & Last Name & Degree
Aurélio Rocha
First Name & Middle Initial & Last Name & Degree
Pablo Santos
First Name & Middle Initial & Last Name & Degree
Barbara Moccelini

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32934983
Citation
Tirupathi SP, Rajasekhar S. Can single buccal infiltration with 4% articaine induce sufficient analgesia for the extraction of primary molars in children: a systematic literature review. J Dent Anesth Pain Med. 2020 Aug;20(4):179-186. doi: 10.17245/jdapm.2020.20.4.179. Epub 2020 Aug 27.
Results Reference
background
PubMed Identifier
32847666
Citation
Taneja S, Singh A, Jain A. Anesthetic Effectiveness of Articaine and Lidocaine in Pediatric Patients During Dental Procedures: A Systematic Review and Meta-Analysis. Pediatr Dent. 2020 Jul 15;42(4):273-281.
Results Reference
background

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Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

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