BridgeMD
New treatment option for Molar Incisor Hypomineralization
Official title Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
ClinicalTrials.gov ID: NCT05964387
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11. Healthy volunteers may be eligible.
You may be able to join if
- At least one hypomineralized first permanent molar with a primary cavitated caries lesion(s) or a cavitated tooth defect requiring restorative dental...
- American Society of Anesthesiologists (ASA) Physical Status Classification I or II (healthy children or those with mild systemic disease)
- English speaking
- people for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated
You likely can't join if
- 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
- people with ulcerative gingivitis or stomatitis
- people with known sensitivity to silver or other heavy-metal ions
See the full eligibility criteria
- 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
- people for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated
- 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
- people with ulcerative gingivitis or stomatitis
- people with known sensitivity to silver or other heavy-metal ions
- people showing abnormal skin sensitization in daily circumstances
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.