Molar Incisor HypomineralisationNCT07118111
Effect of Resin Infiltration on Hypersensitivity and Satisfaction in Children With Enamel Defects
A study testing Resin infiltration in people with Molar Incisor Hypomineralisation and Enamel Hypoplasia, run by Gizem Tıraşçı at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of resin infiltration on dental sensitivity, quality of life, and satisfaction in children aged 7-14 with enamel defects in their front teeth. Forty children received treatment, and outcomes were measured through sensitivity tests and questionnaires for both children and parents. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralisation, Enamel Hypoplasia, Dental Hypersensitivity
- What is being tested?
- Resin infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2025to 13 Jan 2026
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 7 and 14 years.
- Children in good general health without any systemic disease.
- Presence of at least one anterior permanent tooth with hypomineralization or hypoplasia.
- Teeth with lesions larger than 1 mm that are suitable for resin infiltration treatment.
- Voluntary participation of both the child and their parent/guardian in the study, with signed informed consent.
Who cannot join
- Children with systemic diseases or undergoing medical treatment.
- Cases with active caries, trauma, restorations, or endodontic treatment applied or required on anterior teeth.
- Individuals who have previously received resin infiltration or similar treatment on the same tooth.
- Children with a history of allergies or sensitivity to the materials used in the procedure.
- Individuals who have received interventions such as fluoride varnish, fissure sealants, or tooth whitening on their teeth.
- Children who do not possess the cognitive ability to understand and respond to the questionnaire or sensitivity assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Resin Infiltration Treatment on Dental Hypersensitivity and Patient-Parent Satisfaction in Children With Anterior Teeth Affected by Hypomineralization or Hypoplasia
This study evaluates the effect of resin infiltration on dental sensitivity, quality of life, and satisfaction in children aged 7-14 with enamel defects in their front teeth. Forty children received treatment, and outcomes were measured through sensitivity tests and questionnaires for both children and parents.
Read the detailed description
Developmental enamel defects can negatively impact oral health-related quality of life by causing esthetic concerns and dental hypersensitivity in children. This prospective clinical study included 40 children aged 7-14 years diagnosed with hypomineralization or hypoplasia in their anterior teeth. All participants received resin infiltration treatment. Dental hypersensitivity was evaluated pre- and post-treatment using the Schiff Cold Air Sensitivity Scale (SCASS). Oral health-related quality of life was assessed using the Pediatric Oral Health-Related Quality of Life (POQL) scale through both child and parent forms. Post-treatment esthetic satisfaction levels were recorded based on reports from both children and their parents. The study aimed to determine the impact of resin infiltration on improving sensitivity, quality of life, and satisfaction in this population.
- Being tested
- Resin infiltration
- Keywords
- resin infiltration, hypomineralization, hypoplasia, dental sensitivity
- Medical subject headings
- Molar Hypomineralization, Dental Enamel Hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationProcedure or surgery
Application of a low-viscosity resin infiltrant to the anterior teeth affected by enamel defects. This procedure aims to reduce dental hypersensitivity and improve esthetic appearance.
| Study group | Role | What they receive |
|---|---|---|
| Resin Infiltration Treatment Group | Other | All participants receive resin infiltration treatment to anterior teeth affected by enamel defects. Receives: Procedure: Resin infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Hypersensitivity and Patient-Parent Satisfaction
Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment.
Schiff Cold Air Sensitivity Scale (SCASS):
0 - The patient does not respond to the air stimulus.
- - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation.
- - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head.
- - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Change in Dental Hypersensitivity and Patient-Parent Satisfaction
Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment.
Schiff Cold Air Sensitivity Scale (SCASS):
0 - The patient does not respond to the air stimulus.
- - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation.
- - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head.
- - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.
Measured: 1 month, 3 months, and 6 months after treatment
Secondary outcomes (1)
ral Health-Related Quality of Life, Esthetic Evaluation, Treatment Compliance
Oral health-related quality of life (OHRQoL) will be measured using the Pediatric Oral Health-Related Quality of Life (POQL) scale completed by both children and their parents before treatment and at follow-up visits. POQL scores will be calculated on a 0-100 scale, with higher scores indicating a lower quality of life. Esthetic changes will be assessed via clinical evaluations and patient/parent satisfaction surveys. Treatment compliance and acceptability will be recorded during the intervention process. Any adverse effects or complications following resin infiltration treatment will be monitored and documented throughout the study period.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start14 Mar 2025
- Primary completion14 Jun 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group interventional study where all participants receive resin infiltration treatment. There is no comparison or control group. Outcomes such as dental hypersensitivity and patient satisfaction will be measured before and after treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gizem Tıraşçı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gizem Tıraşçı, Inonu University
- Investigators
- Sacide DUMAN, DDS, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118111
- Sponsor's protocol ID
- 2025/7696
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to patient confidentiality concerns and restrictions imposed by the informed consent forms. Additionally, the data contain sensitive personal health information, and sharing is limited to protect participant privacy in accordance with ethical guidelines and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Resin Infiltration Treatment on Dental Hypersensitivity and Patient-Parent Satisfaction in Children With Anterior Teeth Affected by Hypomineralization or Hypoplasia
- ClinicalTrials.gov ID
- NCT07118111
- Acronym / sponsor ID
- 2025/7696
- Keywords
- resin infiltration, hypomineralization, hypoplasia, dental sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gizem TıraşçıUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 14 Jun 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 12 Aug 2025 (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 study evaluates the effect of resin infiltration on dental sensitivity, quality of life, and satisfaction in children aged 7-14 with enamel defects in their front teeth. Forty children received treatment, and outcomes were measured through sensitivity tests and questionnaires for both children and parents.
Detailed description
Developmental enamel defects can negatively impact oral health-related quality of life by causing esthetic concerns and dental hypersensitivity in children. This prospective clinical study included 40 children aged 7-14 years diagnosed with hypomineralization or hypoplasia in their anterior teeth. All participants received resin infiltration treatment. Dental hypersensitivity was evaluated pre- and post-treatment using the Schiff Cold Air Sensitivity Scale (SCASS). Oral health-related quality of life was assessed using the Pediatric Oral Health-Related Quality of Life (POQL) scale through both child and parent forms. Post-treatment esthetic satisfaction levels were recorded based on reports from both children and their parents. The study aimed to determine the impact of resin infiltration on improving sensitivity, quality of life, and satisfaction in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group interventional study where all participants receive resin infiltration treatment. There is no comparison or control group. Outcomes such as dental hypersensitivity and patient satisfaction will be measured before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Resin Infiltration Treatment Group | Other | Procedure: Resin infiltrationAll participants receive resin infiltration treatment to anterior teeth affected by enamel defects. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 7 and 14 years.
- Children in good general health without any systemic disease.
- Presence of at least one anterior permanent tooth with hypomineralization or hypoplasia.
- Teeth with lesions larger than 1 mm that are suitable for resin infiltration treatment.
- Voluntary participation of both the child and their parent/guardian in the study, with signed informed consent.
Key exclusion criteria (6 listed)
- Children with systemic diseases or undergoing medical treatment.
- Cases with active caries, trauma, restorations, or endodontic treatment applied or required on anterior teeth.
- Individuals who have previously received resin infiltration or similar treatment on the same tooth.
- Children with a history of allergies or sensitivity to the materials used in the procedure.
- Individuals who have received interventions such as fluoride varnish, fissure sealants, or tooth whitening on their teeth.
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 |
|---|---|---|
| Resin infiltrationApplication of a low-viscosity resin infiltrant to the anterior teeth affected by enamel defects. This procedure aims to reduce dental hypersensitivity and improve esthetic appearance. | Procedure or surgery | Resin Infiltration Treatment Group |
Primary outcome
Change in Dental Hypersensitivity and Patient-Parent Satisfaction
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment. Schiff Cold Air Sensitivity Scale (SCASS): 0 - The patient does not respond to the air stimulus. 1. - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation. 2. - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head. 3. - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.
Change in Dental Hypersensitivity and Patient-Parent Satisfaction
Time frame: 1 month, 3 months, and 6 months after treatment
Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment. Schiff Cold Air Sensitivity Scale (SCASS): 0 - The patient does not respond to the air stimulus. 1. - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation. 2. - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head. 3. - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.
1 secondary outcome
ral Health-Related Quality of Life, Esthetic Evaluation, Treatment Compliance
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
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 30 Mar 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to patient confidentiality concerns and restrictions imposed by the informed consent forms. Additionally, the data contain sensitive personal health information, and sharing is limited to protect participant privacy in accordance with ethical guidelines and institutional policies.
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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.
Sacide DUMAN, DDS study director
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration in people with Molar Incisor Hypomineralisation and Enamel Hypoplasia, run by Gizem Tıraşçı 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 5 inclusion and 6 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 30 Mar 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?
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?
Change in Dental Hypersensitivity and Patient-Parent Satisfaction (time frame: Baseline, 1 month, 3 months, and 6 months after treatment). 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 30 Mar 2026.