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Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

Primary Purpose

Molar Incisor Hypomineralization, Anesthesia, Local

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SDF
Placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring Silver diamine fluoride

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion 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 Subjects for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated Exclusion Criteria: 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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SDF

Placebo

Arm Description

38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.

Outcomes

Primary Outcome Measures

Sixou and Barbosa-Rogier scale for local anesthesia efficacy
Four point scale evaluating efficacy of local anesthesia

Secondary Outcome Measures

Schiff Cold Air Sensitivity Scale
Four point scale evaluating tooth sensitivity to cold

Full Information

First Posted
July 18, 2023
Last Updated
July 18, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05964387
Brief Title
Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars
Official Title
Effect of Silver Diamine Fluoride on Local Anesthesia Efficacy in Molar Incisor Hypomineralization-affected Molars in Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization, Anesthesia, Local
Keywords
Silver diamine fluoride

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects randomized for application of 38% silver diamine fluoride or placebo on hypomineralized permanent molar two weeks before operative dentistry.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The subject, care provider/outcomes assessor, and investigator will be blinded to which arm the tooth is randomized.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SDF
Arm Type
Experimental
Arm Description
38% SDF applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inert liquid (colored water) applied to hypomineralized permanent molar two weeks prior to restorative care of the tooth.
Intervention Type
Device
Intervention Name(s)
SDF
Other Intervention Name(s)
2% lidocaine with 1:100,000 epinephrine
Intervention Description
38% SDF will be applied to the hypoplastic area of the enrolled first permanent molar.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
An inert liquid will be applied to the hypoplastic area of the enrolled first permanent molar.
Primary Outcome Measure Information:
Title
Sixou and Barbosa-Rogier scale for local anesthesia efficacy
Description
Four point scale evaluating efficacy of local anesthesia
Time Frame
At least two weeks following application of SDF or placebo on the enrolled tooth
Secondary Outcome Measure Information:
Title
Schiff Cold Air Sensitivity Scale
Description
Four point scale evaluating tooth sensitivity to cold
Time Frame
At least two weeks following application of SDF or placebo on the enrolled tooth
Other Pre-specified Outcome Measures:
Title
Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Description
Three point scale evaluating five components of behavior and expression of discomfort in children
Time Frame
At least two weeks following application of SDF or placebo on the enrolled tooth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion 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 Subjects for which basic behavior guidance (non-pharmacological or nitrous oxide/oxygen) is indicated Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Boynton, DDS
Phone
734-763-2331
Email
jboynton@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Boynton, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James R Boynton, DDS
Phone
734-764-1523
Email
jboynton@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data (IPD) is not planned to be shared.

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Effect of Silver Diamine Fluoride on Local Anesthesia in Hypomineralized Molars

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