Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

NCT ID: NCT04061096

Last Updated: 2019-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2018-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Molar Incisor Hypomineralization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

no need

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Evaluation of cold test

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type ACTIVE_COMPARATOR

Evaluation of cold test

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type PLACEBO_COMPARATOR

Evaluation of cold test

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

not MIH-effected non-carious first permanent molar teeth

not any signs of being caries or hypomineralization.

Group Type PLACEBO_COMPARATOR

Evaluation of cold test

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation of cold test

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Evaluation of pain during the treatment

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy participants

Exclusion Criteria

* Not being cooperative during treatment procedure
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Didem Sakaryali

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Didem Sakaryali

Asst. Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Didem Sakaryali, Asst.Prof.

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Didem Sakaryali

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.