Molar-Incisor Hypomineralization (MIH)NCT07759739
Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineralization
A study testing Er:YAG Laser-Assisted Cavity Preparation and Conventional Rotary Cavity Preparation in people with Molar-Incisor Hypomineralization (MIH), run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial compares Er:YAG laser-assisted and conventional rotary cavity preparation in children aged 6-12 years with molar-incisor hypomineralization. A total of 52 children are randomly assigned to one of the two preparation methods. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- Er:YAG Laser-Assisted Cavity Preparation and Conventional Rotary Cavity Preparation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2026to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 12 years.
- Diagnosis of molar-incisor hypomineralization according to the European Academy of Paediatric Dentistry diagnostic criteria.
- Presence of mild or moderate molar-incisor hypomineralization.
- Presence of an erupted mandibular first permanent molar (tooth 36 or 46) requiring restorative treatment.
- Presence of a single-surface occlusal carious lesion classified as ICDAS code 4 or 5.
- Vital target tooth without clinical or radiographic signs of pulpal or periapical pathology.
Show all 10Show fewer
- No previous restorative treatment of the target tooth.
- Cooperative behavior corresponding to Frankl behavior rating scores 3 or 4 and Venham scores 0 to 2.
- Written informed consent provided by a parent or legal guardian.
- Child assent to participate in the study.
Who cannot join
- Presence of a systemic or neurodevelopmental condition that could affect pain perception, anxiety, communication, or cooperation.
- Use of analgesic, anxiolytic, sedative, or other medication that could influence pain or anxiety assessment before treatment.
- Presence of spontaneous dental pain, irreversible pulpitis, pulp necrosis, or periapical pathology in the target tooth.
- Requirement for multisurface cavity preparation or extensive restorative treatment.
- Previous restorative treatment of the target tooth.
- Inability of the child or parent/legal guardian to understand or complete the study assessments.
- Refusal of the child or parent/legal guardian to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Faculty of Dentistry, Department of Pediatric Dentistry
Izmir, İzmir, 35100
About this study
Official title: Comparison of the Clinical Effects of Er:YAG Laser-Assisted and Conventional Cavity Preparation on Pain, Dental Anxiety, Sensory Responses, and Patient Comfort in Children With Molar-Incisor Hypomineralization
This randomized clinical trial compares Er:YAG laser-assisted and conventional rotary cavity preparation in children aged 6-12 years with molar-incisor hypomineralization. A total of 52 children are randomly assigned to one of the two preparation methods. The study evaluates pain, dental anxiety, sensory experiences, physiological responses, patient comfort, need for local anesthesia, and procedure duration. Postoperative discomfort and the clinical performance of restorations are also assessed during follow-up visits at 1, 3, and 6 months.
Read the detailed description
This prospective, parallel-group, randomized clinical trial was conducted to compare the clinical effects of Er:YAG laser-assisted and conventional rotary cavity preparation in children with molar-incisor hypomineralization. Fifty-two children aged 6-12 years requiring restorative treatment of a mandibular first permanent molar were allocated in a 1:1 ratio to either the Er:YAG laser group or the conventional rotary instrument group.
In the laser group, cavity preparation was performed using an Er:YAG laser. In the conventional group, rotary instruments were used. Local anesthesia was not routinely administered but was provided when clinically required. Following cavity preparation, the teeth were restored using the same adhesive system and resin composite material in both groups.
Pain and behavioral responses were assessed using the Wong-Baker FACES Pain Rating Scale and the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was evaluated before and after treatment using the Modified Child Dental Anxiety Scale-Faces version. Heart rate and peripheral oxygen saturation were recorded as physiological indicators. Sensory experiences, overall discomfort, willingness to undergo the same procedure again, need for local anesthesia, cavity preparation time, and total procedure time were also recorded. Postoperative discomfort and the clinical performance of the restorations were evaluated at 1-, 3-, and 6-month follow-up visits.
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- Er:YAG Laser-Assisted Cavity Preparation, Conventional Rotary Cavity Preparation
- Keywords
- Molar-Incisor Hypomineralization, MIH, Er:YAG Laser, Cavity Preparation, Pediatric Dentistry, Dental Anxiety, Dental Pain, Sensory Experience, Restorative Dental Treatment
- Medical subject headings
- Molar Hypomineralization, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG Laser-Assisted Cavity PreparationDevice
Cavity preparation was performed using an Er:YAG laser (2940 nm). Enamel and dentin were selectively removed using laser parameters appropriate for each dental tissue. The prepared cavity was subsequently restored using an adhesive system and resin composi
Conventional Rotary Cavity PreparationProcedure or surgery
Cavity preparation was performed using conventional high-speed rotary instruments and diamond burs. The prepared cavity was subsequently restored using the same adhesive system and resin composite used in the laser group.
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG Laser-Assisted Cavity Preparation | Experimental | Cavity preparation was performed using an Er:YAG laser, followed by restoration with an adhesive system and resin composite. Receives: Device: Er:YAG Laser-Assisted Cavity Preparation |
| Conventional Rotary Cavity Preparation | Active comparator | Cavity preparation was performed using conventional rotary instruments, followed by restoration with the same adhesive system and resin composite. Receives: Procedure: Conventional Rotary Cavity Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Related Behavior Assessed Using the FLACC Scale
Pain-related behavior during cavity preparation was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral responses.
Measured: During cavity preparation
Self-Reported Pain Assessed Using the Wong-Baker FACES Pain Rating Scale
Pain experienced during cavity preparation was self-reported using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain.
Measured: Immediately after cavity preparation
Secondary outcomes (9)
Dental Anxiety Assessed Using the Modified Child Dental Anxiety Scale-Faces Version
Dental anxiety was assessed using the Modified Child Dental Anxiety Scale-Faces version (MCDAS-f). The total score ranges from 8 to 40, with higher scores indicating greater dental anxiety.
Measured: Immediately before and immediately after the restorative procedure
Change in Heart Rate
Heart rate was recorded in beats per minute using a pulse oximeter before and after the restorative procedure.
Measured: From immediately before to immediately after the restorative procedure
Change in Peripheral Oxygen Saturation
Peripheral oxygen saturation was recorded as a percentage using a pulse oximeter before and after the restorative procedure.
Measured: From immediately before to immediately after the restorative procedure
Sensory experience and patient comfort
Children completed a structured questionnaire assessing discomfort related to sound, odor, perceived procedure duration, overall discomfort, and willingness to undergo the same cavity preparation method again. Each item was analyzed separately according to its categorical response options.
Measured: Immediately after the restorative procedure
Requirement for Local Anesthesia
The number of children requiring local anesthesia during cavity preparation was recorded for each study group.
Measured: During cavity preparation
Cavity Preparation Duration
The time required to complete cavity preparation was recorded in seconds.
Measured: During the restorative procedure
Total Restorative Procedure Duration
The total duration of the restorative procedure, including cavity preparation, adhesive application, restoration placement, finishing, and polishing, was recorded in seconds.
Measured: During the restorative procedure
Patient-Reported Discomfort Assessed Using a Visual Analog Scale
Discomfort was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, with higher scores indicating greater discomfort.
Measured: Immediately before treatment, immediately after treatment, and at 1-, 3-, and 6-month follow-up visits
Clinical Performance of Restorations Assessed Using FDI Criteria
The clinical performance of the restorations was evaluated according to the World Dental Federation (FDI) criteria. Restorations were rated from 1 to 5, where scores 1 to 3 indicate clinically acceptable restorations and scores 4 and 5 indicate clinically unacceptable restorations.
Measured: At 1-, 3-, and 6-month follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start3 Jan 2026
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated in a 1:1 ratio to either Er:YAG laser-assisted cavity preparation or conventional rotary cavity preparation.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse KORKUT IŞIK, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759739
- Sponsor's protocol ID
- 25-8/8
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves children, and the informed consent obtained from parents or legal guardians did not include permission for sharing individual-level data with other researchers. This decision is intended to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effects of Er:YAG Laser-Assisted and Conventional Cavity Preparation on Pain, Dental Anxiety, Sensory Responses, and Patient Comfort in Children With Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07759739
- Acronym / sponsor ID
- 25-8/8
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Keywords
- Molar-Incisor Hypomineralization, MIH, Er:YAG Laser, Cavity Preparation, Pediatric Dentistry, Dental Anxiety, Dental Pain, Sensory Experience
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 3 Jan 2026 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 12 Aug 2026 (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.
This randomized clinical trial compares Er:YAG laser-assisted and conventional rotary cavity preparation in children aged 6-12 years with molar-incisor hypomineralization. A total of 52 children are randomly assigned to one of the two preparation methods. The study evaluates pain, dental anxiety, sensory experiences, physiological responses, patient comfort, need for local anesthesia, and procedure duration. Postoperative discomfort and the clinical performance of restorations are also assessed during follow-up visits at 1, 3, and 6 months.
Detailed description
This prospective, parallel-group, randomized clinical trial was conducted to compare the clinical effects of Er:YAG laser-assisted and conventional rotary cavity preparation in children with molar-incisor hypomineralization. Fifty-two children aged 6-12 years requiring restorative treatment of a mandibular first permanent molar were allocated in a 1:1 ratio to either the Er:YAG laser group or the conventional rotary instrument group.
In the laser group, cavity preparation was performed using an Er:YAG laser. In the conventional group, rotary instruments were used. Local anesthesia was not routinely administered but was provided when clinically required. Following cavity preparation, the teeth were restored using the same adhesive system and resin composite material in both groups.
Pain and behavioral responses were assessed using the Wong-Baker FACES Pain Rating Scale and the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was evaluated before and after treatment using the Modified Child Dental Anxiety Scale-Faces version. Heart rate and peripheral oxygen saturation were recorded as physiological indicators. Sensory experiences, overall discomfort, willingness to undergo the same procedure again, need for local anesthesia, cavity preparation time, and total procedure time were also recorded. Postoperative discomfort and the clinical performance of the restorations were evaluated at 1-, 3-, and 6-month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly allocated in a 1:1 ratio to either Er:YAG laser-assisted cavity preparation or conventional rotary cavity preparation.
| Arm | Type | Receives |
|---|---|---|
| Er:YAG Laser-Assisted Cavity Preparation | Experimental | Device: Er:YAG Laser-Assisted Cavity PreparationCavity preparation was performed using an Er:YAG laser, followed by restoration with an adhesive system and resin composite. |
| Conventional Rotary Cavity Preparation | Active comparator | Procedure: Conventional Rotary Cavity PreparationCavity preparation was performed using conventional rotary instruments, followed by restoration with the same adhesive system and resin composite. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children aged 6 to 12 years.
- Diagnosis of molar-incisor hypomineralization according to the European Academy of Paediatric Dentistry diagnostic criteria.
- Presence of mild or moderate molar-incisor hypomineralization.
- Presence of an erupted mandibular first permanent molar (tooth 36 or 46) requiring restorative treatment.
- Presence of a single-surface occlusal carious lesion classified as ICDAS code 4 or 5.
Key exclusion criteria (7 listed)
- Presence of a systemic or neurodevelopmental condition that could affect pain perception, anxiety, communication, or cooperation.
- Use of analgesic, anxiolytic, sedative, or other medication that could influence pain or anxiety assessment before treatment.
- Presence of spontaneous dental pain, irreversible pulpitis, pulp necrosis, or periapical pathology in the target tooth.
- Requirement for multisurface cavity preparation or extensive restorative treatment.
- Previous restorative treatment of the target tooth.
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 |
|---|---|---|
| Er:YAG Laser-Assisted Cavity PreparationCavity preparation was performed using an Er:YAG laser (2940 nm). Enamel and dentin were selectively removed using laser parameters appropriate for each dental tissue. The prepared cavity was subsequently restored using an adhesive system and resin composi | Device | Er:YAG Laser-Assisted Cavity Preparation |
| Conventional Rotary Cavity PreparationCavity preparation was performed using conventional high-speed rotary instruments and diamond burs. The prepared cavity was subsequently restored using the same adhesive system and resin composite used in the laser group. | Procedure or surgery | Conventional Rotary Cavity Preparation |
Primary outcome
Pain-Related Behavior Assessed Using the FLACC Scale
Time frame: During cavity preparation
Pain-related behavior during cavity preparation was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral responses.
Self-Reported Pain Assessed Using the Wong-Baker FACES Pain Rating Scale
Time frame: Immediately after cavity preparation
Pain experienced during cavity preparation was self-reported using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain.
9 secondary outcomes
Dental Anxiety Assessed Using the Modified Child Dental Anxiety Scale-Faces Version
Time frame: Immediately before and immediately after the restorative procedure
Change in Heart Rate
Time frame: From immediately before to immediately after the restorative procedure
Change in Peripheral Oxygen Saturation
Time frame: From immediately before to immediately after the restorative procedure
Sensory experience and patient comfort
Time frame: Immediately after the restorative procedure
Requirement for Local Anesthesia
Time frame: During cavity preparation
Cavity Preparation Duration
Time frame: During the restorative procedure
Total Restorative Procedure Duration
Time frame: During the restorative procedure
Patient-Reported Discomfort Assessed Using a Visual Analog Scale
Time frame: Immediately before treatment, immediately after treatment, and at 1-, 3-, and 6-month follow-up visits
Clinical Performance of Restorations Assessed Using FDI Criteria
Time frame: At 1-, 3-, and 6-month follow-up visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves children, and the informed consent obtained from parents or legal guardians did not include permission for sharing individual-level data with other researchers. This decision is intended to protect participant privacy and confidentiality.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG Laser-Assisted Cavity Preparation and Conventional Rotary Cavity Preparation in people with Molar-Incisor Hypomineralization (MIH), run by Ege University at 1 site in Turkey (Türkiye).
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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain-Related Behavior Assessed Using the FLACC Scale (time frame: During cavity preparation). The study lists 2 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 12 Aug 2026.