Comparative Effect of Palatal Injection in Pediatric Patient

NCT06025825 | Unknown FDA Drug

• 1 other identifier: 26379996/10
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Local Anesthetic Complication

Keywords

local anesthesia; pain

Outcome Measures

Primary Outcomes (2)

• Evaluation of pain during tooth extraction after anesthesia with VAS

  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

  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

Study Arms (6)

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 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 (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 (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 (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 (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

Interventions

Articaine Hydrochloride + Epinephrine DRUG

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.

Also known as: ultracaine ds

Buccal infiltration anesthesia (5 minutes waiting time with articaine HCl); Buccal infiltration anesthesia (8 minutes waiting time with articaine HCl); Buccal infiltration anesthesia + palatal infiltration anesthesia (with articaine HCl)

Lidocaine Hydrochloride + Epinephrine DRUG

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

Also known as: jetocaine

Buccal infiltration anesthesia (5 minutes waiting time with lidocaine HCl); Buccal infiltration anesthesia (8 minutes waiting time with lidocaine HCl); Buccal infiltration anesthesia + palatal infiltration anesthesia (with lidocaine HCl)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım beyazıt University, Faculty of Dentistry

Ankara, 06790, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.

  PMID: 30417227 BACKGROUND

• Raslan N, Masri R. A randomized clinical trial to compare pain levels during three types of oral anesthetic injections and the effect of Dentalvibe(R) on injection pain in children. Int J Paediatr Dent. 2018 Jan;28(1):102-110. doi: 10.1111/ipd.12313. Epub 2017 Jun 24.

  PMID: 28646527 BACKGROUND

• Uckan S, Dayangac E, Araz K. Is permanent maxillary tooth removal without palatal injection possible? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):733-5. doi: 10.1016/j.tripleo.2005.12.005. Epub 2006 Mar 20.

  PMID: 17138173 RESULT

MeSH Terms

Conditions

Pain

Interventions

Carticaine; Epinephrine; Ultracaine D-S; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• ceren tatlı, assist.Prof

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevser sancak

CONTACT

+905556446580; kevsersancak89@gmail.com

Ceren Tatlı

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asistant professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 6, 2023
• Study Start: May 2, 2023
• Primary Completion: August 28, 2023
• Study Completion: September 5, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-08

Locations

TU (1)