Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth

Dental Caries Clinical Trial

Official title:

Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855527
• Other study ID #: SDF as cavity disinfectant
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: April 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of silver diamine fluoride (SDF) compared to chlorhexidine (CHX) as a cavity disinfectant in primary molars after Atraumatic Restorative Treatment approach (ART).

Description:

This study is a three arm randomized controlled clinical trial, where children with an age range of 4-6 years indicated for Atraumatic Restorative Treatment (ART) are selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. Sixty teeth are randomly allocated into 3 groups of Atraumatic restorative treatment approaches. Group I is assigned to silver diamine fluoride as an antibacterial agent, Group II is assigned to chlorhexidine as an antibacterial agent, and Group III serves as a negative control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 20, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children free of any systemic disease or special health care needs.

• Class I cavity involving dentin in primary molars.

• Lesion wide enough to allow access of instruments.

• Informed consent fulfilled.

Exclusion Criteria:

• Signs of irreversible pulpitis or pulp necrosis.

• Patients allergic to silver products.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Silver Diamine Fluoride
SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
• Chlorhexidine
Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)

Procedure:
• Atraumatic Restorative Treatment without Disinfection
Atraumatic Restorative Technique will be performed without cavity disinfection

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Bjørndal L, Larsen T, Thylstrup A. A clinical and microbiological study of deep carious lesions during stepwise excavation using long treatment intervals. Caries Res. 1997;31(6):411-7. — View Citation

Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28. — View Citation

Innes NP, Frencken JE, Bjørndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Doméjean S, Fontana M, Leal S, Lo E, Machiulskiene V, Schulte A, Splieth C, Zandona A, Schwendicke F. Managing Carious Lesions: Consensus Recommendations on Terminology. Adv Dent Res. 2016 May;28(2):49-57. doi: 10.1177/0022034516639276. — View Citation

Joshi JS, Roshan NM, Sakeenabi B, Poornima P, Nagaveni NB, Subbareddy VV. Inhibition of Residual Cariogenic Bacteria in Atraumatic Restorative Treatment by Chlorhexidine: Disinfection or Incorporation. Pediatr Dent. 2017 Jul 15;39(4):308-312. — View Citation

Massara ML, Alves JB, Brandão PR. Atraumatic restorative treatment: clinical, ultrastructural and chemical analysis. Caries Res. 2002 Nov-Dec;36(6):430-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological assessment of total viable bacterial count	The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two microliters of the samples collected will be inoculated on blood agar for total viable count.	First day (baseline)
Primary	Microbiological assessment of streptococcus mutans count	The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity. Two µl of the samples will be inoculated on mitis salivarius agar supplemented with 15 percent sucrose and bacitracin (0.2 U/ml) for selective isolation of Streptococcus mutans.	First day (baseline)
Primary	Microbiological assessment of lactobacilli count	The first dentin sample will be collected with a sterile spoon excavator from the firm dentin in the center of the cavity.Two µl of the samples will be inoculated on Rogosa agar, a medium selective for Lactobacilli.	First day (baseline)
Primary	Change in the total viable count.	A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.	14 days
Primary	Change in the lactobacilli count.	A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.	14 days
Primary	Change in the streptococcus mutans count.	A second dentin sample will be taken from the same position with a sterile round bur for bacteriologic assessment.	14 days
Secondary	Clinical changes in the dentin color	Restoration will be removed and the dentin will be checked using visual-tactile method of examination.	14 days
Secondary	Clinical changes in the dentin consistency	Restoration will be removed and the dentin will be checked using visual-tactile method of examination.	14 days

External Links

•   Manual for the atraumatic restorative treatment approach to control dental caries.
•   Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. reference manual of American academy of pediatric dentistry