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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04061096
Other study ID # Didem Sakaryali
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2014
Est. completion date May 1, 2018

Study information

Verified date August 2019
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- Healthy participants

Exclusion Criteria:

- Not being cooperative during treatment procedure

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Didem Sakaryali

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
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