Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

NCT04061096 | Completed

• 1 other identifier: Didem Sakaryali
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Molar Incisor Hypomineralization

Keywords

Anesthesia; Cold test; Electrical pulp test

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (4)

MIH-effected carious first permanent molar teeth

ACTIVE COMPARATOR

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; Diagnostic Test: Evaluation of electrical pulp test; Diagnostic Test: Evaluation of pain during the treatment

not MIH-effected carious first permanent molar teeth

ACTIVE COMPARATOR

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; Diagnostic Test: Evaluation of electrical pulp test; Diagnostic Test: Evaluation of pain during the treatment

MIH-effected non-carious first permanent molar teeth

PLACEBO COMPARATOR

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; Diagnostic Test: Evaluation of electrical pulp test; Diagnostic Test: Evaluation of pain during the treatment

not MIH-effected non-carious first permanent molar teeth

PLACEBO COMPARATOR

not any signs of being caries or hypomineralization.

Diagnostic Test: Evaluation of cold test; Diagnostic Test: Evaluation of electrical pulp test; Diagnostic Test: Evaluation of pain during the treatment

Interventions

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.

MIH-effected carious first permanent molar teeth; MIH-effected non-carious first permanent molar teeth; not MIH-effected carious first permanent molar teeth; not MIH-effected non-carious first permanent molar teeth

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.

MIH-effected carious first permanent molar teeth; MIH-effected non-carious first permanent molar teeth; not MIH-effected carious first permanent molar teeth; not MIH-effected non-carious first permanent molar teeth

Evaluation of pain during the treatment DIAGNOSTIC_TEST

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

MIH-effected carious first permanent molar teeth; MIH-effected non-carious first permanent molar teeth; not MIH-effected carious first permanent molar teeth; not MIH-effected non-carious first permanent molar teeth

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy participants

You may not qualify if:

• Not being cooperative during treatment procedure

Sponsors & Collaborators

• Didem Sakaryali: lead

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

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

Study Officials

• Didem Sakaryali, Asst.Prof.

  Baskent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no need
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 19, 2019
• Study Start: September 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share