Phase 4 N=20 Treatment

The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions

Caries

Bottom Line

View on ClinicalTrials.gov: NCT02953886 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions — 1890087; 1959306 bacterial count

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Silver Diamine Fluoride (SDF) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Heba Mitwalli
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions	1890087; 1959306	—
PRIMARY Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)	8; 12	—
SECONDARY Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)	1; 18	—

Summary

The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02953886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.