Molar Incisor HypomineralizationNCT05964387
Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
A study testing SDF in people with Molar Incisor Hypomineralization and Anesthesia, Local, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this randomized, controlled clinical study is to evaluate if application of 38% SDF increases the efficacy of local anesthesia during operative dentistry on permanent molars affected by molar-incisor hypoplasia (MIH). Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization, Anesthesia, Local
- What is being tested?
- SDF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 31 Dec 2027
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one hypomineralized first permanent molar with a primary cavitated caries lesion(s) or a cavitated tooth defect requiring restorative dental care with local anesthesia
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II (healthy children or those with mild systemic disease)
- English speaking
- Subjects for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated
Who cannot join
- Teeth with irreversible pulpitis and pulp necrosis
- Patients requiring advanced behavior management such as moderate sedation, general anesthesia, and/or active or passive restraint
- Inability of the child to cooperate due to special needs or other conditions
- Allergy to SDF, local anesthetic or other material component
- Subjects with ulcerative gingivitis or stomatitis
- Subjects with known sensitivity to silver or other heavy-metal ions
- Subjects showing abnormal skin sensitization in daily circumstances
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
James R Boynton, DDS, 734 764-1523, jboynton@umich.edu
About this study
Official title: Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
The purpose of this randomized, controlled clinical study is to evaluate if application of 38% SDF increases the efficacy of local anesthesia during operative dentistry on permanent molars affected by molar-incisor hypoplasia (MIH). The goal is to determine if pre-operative application of SDF results in improved local anesthesia and decrease in procedural pain in MIH affected teeth, thereby addressing an important challenge in routine clinical practice and contributing to the development of a treatment protocol for MIH affected molars.
Read the detailed description
Molar incisor hypomineralization (MIH) is defined as a qualitative enamel defect of unknown etiology that affects one or more permanent molars and may also affect the permanent incisors. Clinically, the presentation of MIH depends on severity: lesions can range from mild, with white to yellow-brown discolored opacities, to severe, with extensive post-eruptive enamel breakdown and atypical caries. Hypomineralized enamel has increased porosity with reduced mineral content, which promotes bacteria penetration, resulting in development and rapid progression of dental caries and subclinical chronic pulp inflammation.
Treatment of teeth affected by MIH pose a clinical challenge due to several reasons. Post-eruptive breakdown of inadequately formed enamel exposes underlying dentin, resulting in hypersensitivity to hot and cold temperatures, air, and water. This increased tooth sensitivity leads to poor oral hygiene and subsequent plaque retention. Additionally, chronic subclinical inflammation of the pulp hypersensitizes the gamma-aminobutyric acid (GABA) receptors in the pulp nerve tissue and reduces the pain threshold in these teeth. This weakens the action of local anesthetics making it difficult to achieve adequate pain control during dental treatment.
Recently, 38% silver diamine fluoride (SDF), a solution of silver fluoride and ammonium ions, has been shown to be effective in tooth desensitization by blocking dentinal tubules and promoting remineralization of demineralized tooth structure. SDF can be useful in managing symptomatic MIH-affected teeth by stimulating the production of calcium fluoride and silver iodide, both of which are able to occlude dentinal tubules and reduce their patency.
The purpose of this randomized, controlled clinical study is to evaluate the efficacy of local anesthesia on MIH-affected molars treated with 38% SDF. The goal is to determine if pre-operative application of SDF results in improved local anesthesia and decrease in procedural pain in MIH affected teeth, thereby addressing an important challenge in routine clinical practice and contributing to the development of a treatment protocol for MIH affected molars.
- Being tested
- SDF, Placebo
- Keywords
- Silver diamine fluoride
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDevice
38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
PlaceboDevice
An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.
| Study group | Role | What they receive |
|---|---|---|
| SDF | Experimental | 38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth. Receives: Device: SDF |
| Placebo | Placebo comparator | Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sixou and Barbosa-Rogier scale for local anesthesia efficacy
Four point scale evaluating efficacy of local anesthesia
Measured: At least two weeks following application of SDF or placebo on the enrolled tooth
Secondary outcomes (1)
Schiff Cold Air Sensitivity Scale
Four point scale evaluating tooth sensitivity to cold
Measured: At least two weeks following application of SDF or placebo on the enrolled tooth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start12 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by University of MichiganThe 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
- Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James R. Boynton, University of Michigan
- Investigators
- James Boynton, DDS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964387
- Sponsor's protocol ID
- HUM00228059
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data (IPD) is not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05964387
- Acronym / sponsor ID
- HUM00228059
- Keywords
- Silver diamine fluoride
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jul 2023 (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 purpose of this randomized, controlled clinical study is to evaluate if application of 38% SDF increases the efficacy of local anesthesia during operative dentistry on permanent molars affected by molar-incisor hypoplasia (MIH). The goal is to determine if pre-operative application of SDF results in improved local anesthesia and decrease in procedural pain in MIH affected teeth, thereby addressing an important challenge in routine clinical practice and contributing to the development of a treatment protocol for MIH affected molars.
Detailed description
Molar incisor hypomineralization (MIH) is defined as a qualitative enamel defect of unknown etiology that affects one or more permanent molars and may also affect the permanent incisors. Clinically, the presentation of MIH depends on severity: lesions can range from mild, with white to yellow-brown discolored opacities, to severe, with extensive post-eruptive enamel breakdown and atypical caries. Hypomineralized enamel has increased porosity with reduced mineral content, which promotes bacteria penetration, resulting in development and rapid progression of dental caries and subclinical chronic pulp inflammation.
Treatment of teeth affected by MIH pose a clinical challenge due to several reasons. Post-eruptive breakdown of inadequately formed enamel exposes underlying dentin, resulting in hypersensitivity to hot and cold temperatures, air, and water. This increased tooth sensitivity leads to poor oral hygiene and subsequent plaque retention. Additionally, chronic subclinical inflammation of the pulp hypersensitizes the gamma-aminobutyric acid (GABA) receptors in the pulp nerve tissue and reduces the pain threshold in these teeth. This weakens the action of local anesthetics making it difficult to achieve adequate pain control during dental treatment.
Recently, 38% silver diamine fluoride (SDF), a solution of silver fluoride and ammonium ions, has been shown to be effective in tooth desensitization by blocking dentinal tubules and promoting remineralization of demineralized tooth structure. SDF can be useful in managing symptomatic MIH-affected teeth by stimulating the production of calcium fluoride and silver iodide, both of which are able to occlude dentinal tubules and reduce their patency.
The purpose of this randomized, controlled clinical study is to evaluate the efficacy of local anesthesia on MIH-affected molars treated with 38% SDF. The goal is to determine if pre-operative application of SDF results in improved local anesthesia and decrease in procedural pain in MIH affected teeth, thereby addressing an important challenge in routine clinical practice and contributing to the development of a treatment protocol for MIH affected molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.
| Arm | Type | Receives |
|---|---|---|
| SDF | Experimental | Device: SDF38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth. |
| Placebo | Placebo comparator | Device: PlaceboInert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At least one hypomineralized first permanent molar with a primary cavitated caries lesion(s) or a cavitated tooth defect requiring restorative dental care with local anesthesia
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II (healthy children or those with mild systemic disease)
- English speaking
- Subjects for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated
Key exclusion criteria (7 listed)
- Teeth with irreversible pulpitis and pulp necrosis
- Patients requiring advanced behavior management such as moderate sedation, general anesthesia, and/or active or passive restraint
- Inability of the child to cooperate due to special needs or other conditions
- Allergy to SDF, local anesthetic or other material component
- Subjects with ulcerative gingivitis or stomatitis
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 |
|---|---|---|
| SDF38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar. | Device | SDF |
| PlaceboAn inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar. | Device | Placebo |
Primary outcome
Sixou and Barbosa-Rogier scale for local anesthesia efficacy
Time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
Four point scale evaluating efficacy of local anesthesia
1 secondary outcome
Schiff Cold Air Sensitivity Scale
Time frame: At least two weeks following application of SDF or placebo on the enrolled tooth
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 Feb 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) is not planned to be shared.
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Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
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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.
James Boynton, DDS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDF in people with Molar Incisor Hypomineralization and Anesthesia, Local, run by University of Michigan at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 12 Feb 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 United States. 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. 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?
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?
Contact James Boynton, DDS (734-763-2331, jboynton@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sixou and Barbosa-Rogier scale for local anesthesia efficacy (time frame: At least two weeks following application of SDF or placebo on the enrolled tooth). 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 Feb 2026.