Caries
Conditions
Keywords
Caries, Cavity, Silver Diamine Fluoride (SDF), HOMINGS
Brief summary
The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.
Detailed description
To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.
Interventions
No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet
Sponsors
The Forsyth Institute
Heba Mitwalli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Generally healthy adult participants 18 years of age and older. * At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).
Exclusion criteria
* Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities. * Patients taking antibiotics within the last two weeks. * Patients using chlorhexidine or fluoride mouth washes within the last two weeks. * Pregnant or breastfeeding women. * Teeth with arrested (hard) cervical or root caries lesions. * Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions | baseline, One month after SDF | Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application. |
| Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard) | One month | Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled) | One month | Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silver Diamine Fluoride (SDF) Application of Silver Diamine Fluoride (SDF) to root or cervical carious lesions (cavities). Collection of plaque pre- and one month post-SDF application.
Silver Diamine Fluoride (SDF): No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Silver Diamine Fluoride (SDF) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 21 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)
Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silver Diamine Fluoride (SDF) | Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard) | Soft | 8 cervical lesions |
| Silver Diamine Fluoride (SDF) | Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard) | Hard | 12 cervical lesions |
Primary
Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions
Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.
Time frame: baseline, One month after SDF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silver Diamine Fluoride (SDF) | Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions | Baseline | 1890087 bacterial count |
| Silver Diamine Fluoride (SDF) | Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions | One month after SDF | 1959306 bacterial count |
Secondary
Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)
Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling.
Time frame: One month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Silver Diamine Fluoride (SDF) | Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled) | Concerned with appearance of tooth | 1 Participants |
| Silver Diamine Fluoride (SDF) | Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled) | Desire for tooth to be filled | 18 Participants |