Molar Incisor HypomineralizationNCT07085689
Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols
A study testing Sodium Fluoride Varnish (5%), Silver diamine fluoride- potassium iodide and Aqueous Silver Fluoride in people with Molar Incisor Hypomineralization, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this research was to evaluate the clinical success of desensitization treatments using four different materials in the first permanent molars (FPMs) affected by MIH. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Sodium Fluoride Varnish (5%), Silver diamine fluoride- potassium iodide and Aqueous Silver Fluoride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 9 May 2025
- 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
- Healthy children, aged 7-14 years, who attended the pediatric dentistry clinic regular dental examination
- Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
- Presenting at least one FPMs that were fully erupted and has level 2 or 3 according to the Schiff Cold Air Sensitivity Scale
Who cannot join
- Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
- Enamel defect due to a condition other than MIH
- FPMs to be treated must not have been previously treated with a desensitizing agent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols in Permanent Teeth Affected by Molar Incisor Hypomineralization
The objective of this research was to evaluate the clinical success of desensitization treatments using four different materials in the first permanent molars (FPMs) affected by MIH.
Read the detailed description
A total of 121 teeth with a Schiff cold air sensitivity scale (SCASS) score of 2 or 3 were included in 52 children (between 7-14 years). The FPMs were randomized into four groups; 5% sodium fluoride varnish (Group 1), silver diamine fluoride (Group 2), ammonia-free aqueous silver fluoride (Group 3), and hydroxyethyl methacrylate with glutaraldehyde (Group 4). Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. The two methods used at baseline for sensitivity assessment (SCASS for air sensitivity and the Wong-Baker pain rating scale for touch sensitivity) were used. Pain status during tooth brushing, pain during consumption of hot/cold/sweet/sour foods and beverages, pain during breathing (present/absent), gingival irritation, taste changes, post-eruptive breakdown, caries, spontaneous pain, mucosal swelling/fistula tract, mobility, and percussion/palpation sensitivity were evaluated. All sensitivity assessments were performed blindly by a researcher who did not know the baseline scores or the treatment administered. Statistical analysis was performed using SPSS 27.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p<0.05. The assumption of normal distribution was checked using the Shapiro-Wilk test. The Kruskal-Wallis test was used to compare three or more independent groups that did not have a normal distribution. The Friedman test was performed to examine the difference between three dependent groups where the normality assumption was not met. Post Hoc Adjusted Bonferroni tests were performed to determine the group or groups causing the difference. To test the relationship between categorical variables, the Pearson chi-square test was applied when the sample size assumption (expected value >5) was met, and Fisher's exact chi-square test was applied when the sample size assumption was not met.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Sodium Fluoride Varnish (5%), Silver diamine fluoride- potassium iodide, Aqueous Silver Fluoride, Hydroxyethyl Methacrylate and Glutaraldehyde
- Keywords
- molar incisor hypomineralization, hypersensitivity, desensitization
- Medical subject headings
- Molar Hypomineralization, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Fluoride Varnish (5%)Device
Also called Proshield Varnish
After isolating and drying the teeth to be treated using cotton rolls, 5% sodium fluoride (NaF) varnish (Proshield Varnish, President Dental, Munich, Germany) was applied to the tooth surfaces in two thin layers with the help of a disposable microbrush. The cotton rolls were then removed to allow the varnish to come into contact with saliva and harden. After the procedure, participants were advised to avoid consuming hard foods and brushing their teeth for 4 to 6 hours.
Silver diamine fluoride- potassium iodideDevice
Also called Riva Star
After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% silver diamine fluoride (Riva Star, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet.
Aqueous Silver FluorideDevice
Also called Riva Star Aqua
After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% aqueous silver fluoride (Riva Star Aqua, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet.
Hydroxyethyl Methacrylate and GlutaraldehydeDevice
Also called Gluma Desensitizer
After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. One to two drops of a desensitizing agent containing hydroxyethyl methacrylate and glutaraldehyde (Gluma, Heraeus Kulzer GmbH, Hanau, Germany) were applied to the tooth surface using a disposable microbrush in a rubbing motion. After waiting for 30-60 seconds, the tooth surface was completely dried until the liquid disappeared and the surface lost its shine, and then rinsed with water.
| Study group | Role | What they receive |
|---|---|---|
| 5% Sodium Fluoride Varnish | Active comparator | After isolating and drying the teeth to be treated using cotton rolls, 5% sodium fluoride (NaF) varnish (Proshield Varnish, President Dental, Munich, Germany) was applied to the tooth surfaces in two thin layers with the help of a disposable microbrush. The cotton rolls were then removed to allow the varnish to come into contact with saliva and harden. After the procedure, participants were advised to avoid consuming hard foods and brushing their teeth for 4 to 6 hours. Receives: Device: Sodium Fluoride Varnish (5%) |
| Silver Diamine Fluoride | Active comparator | After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% silver diamine fluoride (Riva Star, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet. Receives: Device: Silver diamine fluoride- potassium iodide |
| Aqueous Silver Fluoride | Active comparator | After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% aqueous silver fluoride (Riva Star Aqua, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet. Receives: Device: Aqueous Silver Fluoride |
| Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma) | Active comparator | After isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. One to two drops of a desensitizing agent containing hydroxyethyl methacrylate and glutaraldehyde (Gluma, Heraeus Kulzer GmbH, Hanau, Germany) were applied to the tooth surface using a disposable microbrush in a rubbing motion. After waiting for 30-60 seconds, the tooth surface was completely dried until the liquid disappeared and the surface lost its shine, and then rinsed with water. Receives: Device: Hydroxyethyl Methacrylate and Glutaraldehyde |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schiff Cold Air Sensitivity Scale for air sensitivity
Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. The The Schiff Cold Air Sensitivity Scale (SCASS) was used by the examiner to assess the subjects' response to this stimulus. Scoring was performed as follows: 0=subject does not respond to air stimulus; 1=subject responds to air stimulus but does not request discontinuation of stimulus; 2=subject responds to air stimulus and requests discontinuation or moves away from stimulus; and 3=subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Measured: 6 months
Wong-Baker Pain Rating Scale for tactile sensitivity
Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. Tactile hypersensitivity was assessed by scratching on the surface of the MIH-affected tooth with a dental explorer (max. twice scratches back and forth). The children scored pain intensity with the Wong Baker Faces Scale (WBFS) (0 = no hurt and 10 = hurts worst).
Measured: 6 months
Secondary outcomes (1)
Hypersensitivity during tooth brushing, consumption of hot/cold/sweet/sour foods and beverages or during breathing
Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. Pain status during tooth brushing, pain during consumption of hot/cold/sweet/sour foods and beverages, pain during breathing (present/absent), gingival irritation, taste changes, post-eruptive breakdown, caries, spontaneous pain, mucosal swelling/fistula tract, mobility, and percussion/palpation sensitivity were evaluated (present/absent).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start20 Apr 2023
- Primary completion3 Jan 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- four intervention groups, randomized, single-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beste Ozgur, Hacettepe University
- Investigators
- Beste Ozgur, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085689
- Sponsor's protocol ID
- HUDHF-MIH-desensitization
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozgul BM, Saat S, Sonmez H, Oz FT. Clinical evaluation of desensitizing treatment for incisor teeth affected by molar-incisor hypomineralization. J Clin Pediatr Dent. 2013 Winter;38(2):101-5.
PubMed 24683770Cavalcante BGN, Mlinko E, Szabo B, Teutsch B, Hegyi P, Vag J, Nemeth O, Gerber G, Varga G. Non-Invasive Strategies for Remineralization and Hypersensitivity Management in Molar-Incisor Hypomineralization-A Systematic Review and Meta-Analysis. J Clin Med. 2024 Nov 26;13(23):7154. doi: 10.3390/jcm13237154.
PubMed 39685613Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.
PubMed 34743243Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
PubMed 11641576
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Various Desensitizing Treatment Protocols in Permanent Teeth Affected by Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07085689
- Acronym / sponsor ID
- HUDHF-MIH-desensitization
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- molar incisor hypomineralization, hypersensitivity, desensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 25 Jul 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.
The objective of this research was to evaluate the clinical success of desensitization treatments using four different materials in the first permanent molars (FPMs) affected by MIH.
Detailed description
A total of 121 teeth with a Schiff cold air sensitivity scale (SCASS) score of 2 or 3 were included in 52 children (between 7-14 years). The FPMs were randomized into four groups; 5% sodium fluoride varnish (Group 1), silver diamine fluoride (Group 2), ammonia-free aqueous silver fluoride (Group 3), and hydroxyethyl methacrylate with glutaraldehyde (Group 4). Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. The two methods used at baseline for sensitivity assessment (SCASS for air sensitivity and the Wong-Baker pain rating scale for touch sensitivity) were used. Pain status during tooth brushing, pain during consumption of hot/cold/sweet/sour foods and beverages, pain during breathing (present/absent), gingival irritation, taste changes, post-eruptive breakdown, caries, spontaneous pain, mucosal swelling/fistula tract, mobility, and percussion/palpation sensitivity were evaluated. All sensitivity assessments were performed blindly by a researcher who did not know the baseline scores or the treatment administered. Statistical analysis was performed using SPSS 27.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p<0.05. The assumption of normal distribution was checked using the Shapiro-Wilk test. The Kruskal-Wallis test was used to compare three or more independent groups that did not have a normal distribution. The Friedman test was performed to examine the difference between three dependent groups where the normality assumption was not met. Post Hoc Adjusted Bonferroni tests were performed to determine the group or groups causing the difference. To test the relationship between categorical variables, the Pearson chi-square test was applied when the sample size assumption (expected value >5) was met, and Fisher's exact chi-square test was applied when the sample size assumption was not met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- four intervention groups, randomized, single-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| 5% Sodium Fluoride Varnish | Active comparator | Device: Sodium Fluoride Varnish (5%)After isolating and drying the teeth to be treated using cotton rolls, 5% sodium fluoride (NaF) varnish (Proshield Varnish, President Dental, Munich, Germany) was applied to the tooth surfaces in two thin layers with the help of a disposable microbrush. The cotton rolls were then removed to allow the varnish to come into contact with saliva and harden. After the procedure, participants were advised to avoid consuming hard foods and brushing their teeth for 4 to 6 hours. |
| Silver Diamine Fluoride | Active comparator | Device: Silver diamine fluoride- potassium iodideAfter isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% silver diamine fluoride (Riva Star, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet. |
| Aqueous Silver Fluoride | Active comparator | Device: Aqueous Silver FluorideAfter isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% aqueous silver fluoride (Riva Star Aqua, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet. |
| Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma) | Active comparator | Device: Hydroxyethyl Methacrylate and GlutaraldehydeAfter isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. One to two drops of a desensitizing agent containing hydroxyethyl methacrylate and glutaraldehyde (Gluma, Heraeus Kulzer GmbH, Hanau, Germany) were applied to the tooth surface using a disposable microbrush in a rubbing motion. After waiting for 30-60 seconds, the tooth surface was completely dried until the liquid disappeared and the surface lost its shine, and then rinsed with water. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children, aged 7-14 years, who attended the pediatric dentistry clinic regular dental examination
- Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
- Presenting at least one FPMs that were fully erupted and has level 2 or 3 according to the Schiff Cold Air Sensitivity Scale
Key exclusion criteria (3 listed)
- Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
- Enamel defect due to a condition other than MIH
- FPMs to be treated must not have been previously treated with a desensitizing agent.
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 |
|---|---|---|
| Sodium Fluoride Varnish (5%)Also: Proshield VarnishAfter isolating and drying the teeth to be treated using cotton rolls, 5% sodium fluoride (NaF) varnish (Proshield Varnish, President Dental, Munich, Germany) was applied to the tooth surfaces in two thin layers with the help of a disposable microbrush. The cotton rolls were then removed to allow the varnish to come into contact with saliva and harden. After the procedure, participants were advised to avoid consuming hard foods and brushing their teeth for 4 to 6 hours. | Device | 5% Sodium Fluoride Varnish |
| Silver diamine fluoride- potassium iodideAlso: Riva StarAfter isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% silver diamine fluoride (Riva Star, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet. | Device | Silver Diamine Fluoride |
| Aqueous Silver FluorideAlso: Riva Star AquaAfter isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. After applying petroleum jelly to the lips for isolation, the first step, 38% aqueous silver fluoride (Riva Star Aqua, SDI, Bayswater, Australia), was applied to the entire tooth surface using a disposable microbrush. Immediately afterward, the second step, potassium iodide, was applied generously to the entire tooth surface using another disposable microbrush. The agent was applied until the creamy white appearance on the tooth disappeared. Excess material on the tooth surface was gently dabbed dry with a cotton pellet. | Device | Aqueous Silver Fluoride |
| Hydroxyethyl Methacrylate and GlutaraldehydeAlso: Gluma DesensitizerAfter isolating and drying the teeth to be treated using cotton rolls, a gingival barrier (Top Dam, FGM Dental Group, Brazil) was applied around the cervical area of the crown to cover the surrounding gingiva and was light-cured. One to two drops of a desensitizing agent containing hydroxyethyl methacrylate and glutaraldehyde (Gluma, Heraeus Kulzer GmbH, Hanau, Germany) were applied to the tooth surface using a disposable microbrush in a rubbing motion. After waiting for 30-60 seconds, the tooth surface was completely dried until the liquid disappeared and the surface lost its shine, and then rinsed with water. | Device | Hydroxyethyl Methacrylate and Glutaraldehyde (Gluma) |
Primary outcome
Schiff Cold Air Sensitivity Scale for air sensitivity
Time frame: 6 months
Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. The The Schiff Cold Air Sensitivity Scale (SCASS) was used by the examiner to assess the subjects' response to this stimulus. Scoring was performed as follows: 0=subject does not respond to air stimulus; 1=subject responds to air stimulus but does not request discontinuation of stimulus; 2=subject responds to air stimulus and requests discontinuation or moves away from stimulus; and 3=subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Wong-Baker Pain Rating Scale for tactile sensitivity
Time frame: 6 months
Clinical evaluations were conducted at baseline, 15 minutes post-treatment, and at 1-week, 1-month, and 6-month follow-up. Tactile hypersensitivity was assessed by scratching on the surface of the MIH-affected tooth with a dental explorer (max. twice scratches back and forth). The children scored pain intensity with the Wong Baker Faces Scale (WBFS) (0 = no hurt and 10 = hurts worst).
1 secondary outcome
Hypersensitivity during tooth brushing, consumption of hot/cold/sweet/sour foods and beverages or during breathing
Time frame: 6 months
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 25 Jul 2025.
- Background: PubMed 24683770Ozgul BM, Saat S, Sonmez H, Oz FT. Clinical evaluation of desensitizing treatment for incisor teeth affected by molar-incisor hypomineralization. J Clin Pediatr Dent. 2013 Winter;38(2):101-5.
- Results publication: PubMed 39685613Cavalcante BGN, Mlinko E, Szabo B, Teutsch B, Hegyi P, Vag J, Nemeth O, Gerber G, Varga G. Non-Invasive Strategies for Remineralization and Hypersensitivity Management in Molar-Incisor Hypomineralization-A Systematic Review and Meta-Analysis. J Clin Med. 2024 Nov 26;13(23):7154. doi: 10.3390/jcm13237154.
- Results publication: PubMed 34743243Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.
- Results publication: PubMed 11641576Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
- Individual participant dataSharing planned: No
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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.
Beste Ozgur study director
Hacettepe 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 Sodium Fluoride Varnish (5%), Silver diamine fluoride- potassium iodide and Aqueous Silver Fluoride in people with Molar Incisor Hypomineralization, run by Hacettepe 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 3 inclusion and 3 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 25 Jul 2025. 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?
Schiff Cold Air Sensitivity Scale for air sensitivity (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT07085689, which also lists 4 linked publications.
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 25 Jul 2025.