Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

Effectiveness Of Local Anesthesia In Molar Teeth With Molar Incisor Hypomineralization-A Prospective Study

To compare responses to electrical pulp test (EPT) and cold test among molar incisor hypomineralization (MIH)-effected and not MIH-effected carious teeth before and after administration of local anesthesia for caries removal.

Study Overview

• Status: Completed
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Diagnostic test: Evaluation of cold test; Diagnostic test: Evaluation of electrical pulp test; Diagnostic test: Evaluation of pain during the treatment

Detailed Description

Fifty carious permanent first molar teeth (25 MIH-effected, 25 not MIH-effected) were included. Firstly, radiographic caries depth, International Caries Detection and Assessment System (ICDAS) codes and MIH levels of teeth were recorded. Then, during the treatment, EPT and cold test were performed before and after the administration of local anesthesia. Visual Analog Scale for Pain was used to evaluate cold test and pain during treatment. When interpreting results, significancy level was stated for the values of p<0.05.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy participants

Exclusion Criteria:

• Not being cooperative during treatment procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MIH-effected carious first permanent molar teeth; MIH-effected carious permanent first molar teeth were well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.	Diagnostic test: Evaluation of cold test; Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.; Diagnostic test: Evaluation of electrical pulp test; Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.; Diagnostic test: Evaluation of pain during the treatment; Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
Active Comparator: not MIH-effected carious first permanent molar teeth; The carious not MIH-effected teeth were only carious without any hypomineralize areas and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.	Diagnostic test: Evaluation of cold test; Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.; Diagnostic test: Evaluation of electrical pulp test; Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.; Diagnostic test: Evaluation of pain during the treatment; Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
Placebo Comparator: MIH-effected non-carious first permanent molar teeth; MIH-effected teeth were carious permanent first molar teeth with well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and did not have any sign of caries.	Diagnostic test: Evaluation of cold test; Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.; Diagnostic test: Evaluation of electrical pulp test; Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.; Diagnostic test: Evaluation of pain during the treatment; Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
Placebo Comparator: not MIH-effected non-carious first permanent molar teeth; not any signs of being caries or hypomineralization.	Diagnostic test: Evaluation of cold test; Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.; Diagnostic test: Evaluation of electrical pulp test; Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.; Diagnostic test: Evaluation of pain during the treatment; Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold test results	Visual Analog Scale for Pain was used to evaluate the cold tests for before and after the local anesthesia. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".	Time frame of cold test evaluation was aproximately 1 hour for each participant.
Electrical pulp test results	Electrical pulp test values at which patients felt sensitive were recorded.	Time frame of electrical pulp test evaluation was aproximately 1 hour for each participant.
Pain during the treatment	Visual Analog Scale for Pain was used to evaluate the pain during the treatment. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".	Pain during the treatment was evaluated for aproximately 1 hour for each participant.

Collaborators and Investigators

• Sponsor: Didem Sakaryali
• Investigators: Principal Investigator: Didem Sakaryali, Asst.Prof., Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: August 10, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Anesthesia; Cold test; Electrical pulp test
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: Didem Sakaryali

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The authors decided to share the information of this study after the study will be published in a scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No