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Completed

NCT Number: NCT04061096

Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

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.

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Key information

Conditions

Molar Incisor Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy participants

Exclusion criteria

  • Not being cooperative during treatment procedure

Treatment and study plan

Evaluation of cold test

Diagnostic Test

Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.

Evaluation of electrical pulp test

Diagnostic Test

Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.

Evaluation of pain during the treatment

Diagnostic Test

Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.

Primary outcomes

  1. Cold test results

    Time frame: Time frame of cold test evaluation was aproximately 1 hour for each participant.

    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".

  2. Electrical pulp test results

    Time frame: Time frame of electrical pulp test evaluation was aproximately 1 hour for each participant.

    Electrical pulp test values at which patients felt sensitive were recorded.

  3. Pain during the treatment

    Time frame: Pain during the treatment was evaluated for aproximately 1 hour for each participant.

    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".

Sponsors and collaborators

Lead sponsor

Didem Sakaryali

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2019
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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