Comparative Effect of Palatal Injection in Pediatric Patient

August 30, 2023 updated by: Kevser SANCAK, Ankara Yildirim Beyazıt University

Comparative Effect of Palatal Injection on Pain Perception in Pediatric Patient

The aim of this study is to compare the pain perception of pediatric patients during extraction with and without palatal injection and to show whether articaine HCl and lidocaine HCl can provide palatal anesthesia in maxillary tooth extraction without the need for a second palatal injection. In addition, to evaluate the superiority of articaine HCl and lidocaine HCl to each other in providing local anesthesia and to compare pain control between each other. An observational prospective clinical study is planned to be performed in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. Patients will be divided into 6 groups. After the application of anesthesia and after tooth extraction, the pain they feel with visual analogue scale and the level of pain observed with the Wong-Baker faces pain rating scale will be marked.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication. It is planned to include 96 children in the study. According to studies, under the assumption that a difference of 5 units in the number of patients would be considered significant, it was planned to include at least 5 patients in each group at 95 power and α=0.05 significance level. However, the number of patients has been updated to 96 by increasing the effect size for more meaningful results.

6 different groups will be formed in patients.

  1. st group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)
  2. nd group: Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)
  3. rd group: Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl)
  4. th group: Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl)
  5. th group: Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl)
  6. th group: Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl) Behavioral guidance will be given to all patients who have an indication for tooth extraction for various reasons and will be included in the study with the tell-show-do technique before treatment, after clinical and radiographic examinations. Topical anesthesia will be applied with Ultracare 20% benzocaine gel (Ultradent Products Inc., USA) for 1 minute to the mucobuccal fold area closest to the tooth to be extracted. The same application will be applied to the palatal region for the groups that will undergo palatal anesthesia. Then, for group 1, group 3 and group 5, a local anesthetic containing 1:100,000 adrenaline and articaine HCL 4%; For Group 2, Group 4 and Group 6, local anesthetic containing 20 mg/ml+0.0125 mg/ml adrenaline and lidocaine HCL was injected through a 30 gauge dental needle. 0.5 in Group 1 and Group 2. cc will be used for buccal anesthesia, 0.2 cc anesthesia will be used for palatal anaesthesia. For other groups, 1 cc of anesthesia will be administered from the buccal. After the application of local anesthesia, tooth extraction will be performed. All anesthesia applications and tooth extractions will be performed by the same pediatric dentist (E.C.T). Patients will be asked to evaluate their pain after dental anesthesia and tooth extraction separately with VAS. It will also be evaluated by the Physician performing the procedure with the Wong-Baker evaluation scale.

Among the different pain assessment methods reported in the literature, rating scales to measure their intensity are mostly used in clinical studies as they represent themselves. The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line.

The dentist who performed the tooth extraction marked the line representing the level of pain intensity perceived by the patients. The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a scale from 0 to 10 indicated on the scale... Face 0 does not hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine' it denotes.

Study Type

Observational

Enrollment (Estimated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ceren Tatlı

Study Locations

  • Turkey
      • Ankara, Turkey, 06790
        • Recruiting
        • Ankara Yıldırım beyazıt University, Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study is planned to be carried out in children aged 8-12 years with maxillary tooth extraction indication.

Description

Inclusion Criteria:

  • The child has no systemic disease
  • Absence of acute toothache
  • Child's first tooth extraction treatment
  • No suspected allergy to benzocaine, lidocaine or articaine
  • Comply with Frankl's 3 or Frankl's 4 behavioral assessments

Exclusion Criteria:

  • Patients who do not want to participate in the study
  • Any systemic condition
  • Patients with any drug or local anesthetic allergy
  • Patient has acute toothache or abscess
  • Patients with previous tooth extraction experience
  • Frankl 1 and Frankl 2 patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)
Before extraction, buccal and palatal infiltration anesthesia with articaine will perform. Following anesthesia, extraction will carry out.
Drug: Articaine Hydrochloride + Epinephrine

Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction.

Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction.

Other Names:
  • ultracaine ds
Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)
Before extraction, buccal and palatal infiltration anesthesia with lidocaine will perform. Following anesthesia, extraction will carry out.
Drug: Lidocaine Hydrochloride + Epinephrine
Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group
Other Names:
  • jetocaine
Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl)
Before extraction, buccal infiltration anesthesia with articaine will perform. After 5 minutes, extraction will carry out.
Drug: Articaine Hydrochloride + Epinephrine

Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction.

Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction.

Other Names:
  • ultracaine ds
Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl)
Before extraction, buccal infiltration anesthesia with lidocaine will perform. After 5 minutes, extraction will carry out.
Drug: Lidocaine Hydrochloride + Epinephrine
Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group
Other Names:
  • jetocaine
Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl)
Before extraction, buccal infiltration anesthesia with articaine will perform. After 8 minutes, extraction will carry out.
Drug: Articaine Hydrochloride + Epinephrine

Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl) was applied for first group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction.

Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction.

Other Names:
  • ultracaine ds
Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl)
Before extraction, buccal infiltration anesthesia with lidocaine will perform. After 8 minutes, extraction will carry out.
Drug: Lidocaine Hydrochloride + Epinephrine
Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl) was applied for second group Buccal infiltration anesthesia was applied and 5 minutes was waited before extraction for fourth group Buccal infiltration anesthesia was applied and 8 minutes was waited before extraction for sixth group
Other Names:
  • jetocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of pain during tooth extraction after anesthesia with VAS
Time Frame: baseline and maximum 8 minutes
The VAS is one of the most commonly used self-reported measures of pain; It measures a property that is believed to change over a continuum of values that are not easy to measure directly. However, it is a one-dimensional scale that measures only the sensory component or intensity of the pain experience. The millimeter scale is the most commonly used measuring range and produces a possible score range of 0 to 100 with a 10 cm line
baseline and maximum 8 minutes
Evaluation of pain during tooth extraction after anesthesia with Wong-Baker
Time Frame: baseline and maximum 8 minutes
The Wong-Baker faces pain rating scale (WBFPS) presents 6 faces with increasing pain rating from left to right. Each face was assigned a score from 0 to 10, indicated on the scale. it means that Face 0 doesn't hurt at all, Face 2 hurts a little, Face 4 hurts a little more, Face 6 hurts more, Face 8 hurts a lot, and Face 10 hurts as much as you can imagine
baseline and maximum 8 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: ceren tatlı, assist.Prof, Ankara Yildirim Beyazıt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

August 28, 2023

Study Completion (Estimated)

September 5, 2023

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26379996/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Local Anesthetic Complication

Clinical Trials on Articaine Hydrochloride + Epinephrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe