Phase 3
N=44
Antibacterial Effect of Nano Silver Fluoride vs Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03186261 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Bacterial Count of Streptococus Mutans — 2.00; 2.04; 1.12; 1.05 CFU/ml log10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nano silver fluoride solution (Drug); Cavity Cleanser (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cairo University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bacterial Count of Streptococus Mutans |
2.00; 2.04; 1.12; 1.05 | — |
Summary
* The teeth of the patients that meet inclusion criteria will be anesthetized, isolated with a rubber dam.
* Cavity opened using conventional high-speed rotary instruments.
* The central cariogenic biomass and the superficial parts of the necrotic dentine will be removed with round burs.
* Caries lesion will be completely removed in the enamel/dentin junction.
* The excavation procedure will be terminated as soon as the soft and wet dentine was removed and the remaining tissue was leathery but not hard on exploring.
* A dentinal sample will then be collected from the base of the cavity using sterile spoon excavator as a baseline for bacteriological assessment.
* Then, application of either intervention or control agent, another dentinal sample will be collected using a sterile excavator and transferred into sterile tubes and transferred to the laboratory for microbiological analysis.
* Filling of the cavity with resin composite restoration.
* All clinical procedures will be carried out at the same visit.
Eligibility Criteria
Inclusion Criteria
- Inclusion Criteria of participants:
- Not received antibiotic therapy since 1 month before sampling.
- Good oral hygiene.
- Co-operative patients approving the trial.
- Inclusion Criteria of teeth:
- Class I deep caries lesions in permanent molar (reaching ≥ 1/2 of the dentin on radiographic examination).
- Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).
Exclusion Criteria
- Exclusion criteria of participants:
- Pregnancy.
- Systemic disease or severe medical complications.
- Heavy smoking.
- Xerostomia.
- Lack of compliance.
- Exclusion criteria of teeth:
- Class II caries lesion.
- Shallow or enamel caries.
- Cuspal loss or caries beneath the gingival margin.
Data sourced from ClinicalTrials.gov (NCT03186261). 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.