Molar Incisor HypomineralizationNCT04061096
Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization
A study testing Evaluation of cold test, Evaluation of electrical pulp test and Evaluation of pain during the treatment in people with Molar Incisor Hypomineralization, run by Didem Sakaryali.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Evaluation of cold test, Evaluation of electrical pulp test and Evaluation of pain during the treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy participants
Who cannot join
- Not being cooperative during treatment procedure
About this study
Official title: 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.
Read the 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.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Evaluation of cold test, Evaluation of electrical pulp test, Evaluation of pain during the treatment
- Keywords
- Anesthesia, Cold test, Electrical pulp test
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of cold testDiagnostic test
Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.
Evaluation of electrical pulp testDiagnostic 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 treatmentDiagnostic test
Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Evaluation of cold test; Diagnostic Test: Evaluation of electrical pulp test; Diagnostic Test: Evaluation of pain during the treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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".
Measured: Pain during the treatment was evaluated for aproximately 1 hour for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Sep 2014
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem Sakaryali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Didem Sakaryali, Baskent University
- Investigators
- Didem Sakaryali, Asst.Prof., Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061096
- Sponsor's protocol ID
- Didem Sakaryali
- Status last verified
- Aug 2019
- First submitted
- 10 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors decided to share the information of this study after the study will be published in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Local Anesthesia In Molar Teeth With Molar Incisor Hypomineralization-A Prospective Study
- ClinicalTrials.gov ID
- NCT04061096
- Acronym / sponsor ID
- Didem Sakaryali
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Anesthesia, Cold test, Electrical pulp test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Didem SakaryaliUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MIH-effected carious first permanent molar teeth | Active comparator | Diagnostic Test: Evaluation of cold test, Diagnostic Test: Evaluation of electrical pulp test, Diagnostic Test: Evaluation of pain during the treatmentMIH-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. |
| not MIH-effected carious first permanent molar teeth | Active comparator | Diagnostic Test: Evaluation of cold test, Diagnostic Test: Evaluation of electrical pulp test, Diagnostic Test: Evaluation of pain during the treatmentThe 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. |
| MIH-effected non-carious first permanent molar teeth | Placebo comparator | Diagnostic Test: Evaluation of cold test, Diagnostic Test: Evaluation of electrical pulp test, Diagnostic Test: Evaluation of pain during the treatmentMIH-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. |
| not MIH-effected non-carious first permanent molar teeth | Placebo comparator | Diagnostic Test: Evaluation of cold test, Diagnostic Test: Evaluation of electrical pulp test, Diagnostic Test: Evaluation of pain during the treatmentnot any signs of being caries or hypomineralization. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy participants
Key exclusion criteria (1 listed)
- Not being cooperative during treatment procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of cold testCold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules. | Diagnostic test | 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 testElectrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue. | Diagnostic test | 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 treatmentDescribe the sensitivity level due to induce the hydrodynamic forces during treatment procedure. | Diagnostic test | 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 |
Primary outcome
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".
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.
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: No. The authors decided to share the information of this study after the study will be published in a scientific journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didem Sakaryali, Asst.Prof. principal investigator
Baskent University
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of cold test, Evaluation of electrical pulp test and Evaluation of pain during the treatment in people with Molar Incisor Hypomineralization, run by Didem Sakaryali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cold test results (time frame: Time frame of cold test evaluation was aproximately 1 hour for each participant.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.