Clinical trial NCT03855527: Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth
Official title: Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: Atraumatic Restorative Treatment
Chlorhexidine
Silver Diamine Fluoride
Primary Teeth
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a three arm randomized controlled clinical trial, where children indicated for Atraumatic Restorative Treatment (ART) will be selected.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microbiological assessment of total viable bacterial count
timeFrame: First day (baseline)
measure: Microbiological assessment of streptococcus mutans count
timeFrame: First day (baseline)
measure: Microbiological assessment of lactobacilli count
timeFrame: First day (baseline)
measure: Change in the total viable count.
timeFrame: 14 days
measure: Change in the lactobacilli count.
timeFrame: 14 days
measure: Change in the streptococcus mutans count.
timeFrame: 14 days
Secondary outcomes:
measure: Clinical changes in the dentin color
timeFrame: 14 days
measure: Clinical changes in the dentin consistency
timeFrame: 14 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Lina A Matar, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Karin ML Dowidar, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Dalia AM Talaat, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria Univerity
name: Dina AE Kholeif, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: Innes NP, Frencken JE, Bjorndal L, Maltz M, Manton DJ, Ricketts D, Van Landuyt K, Banerjee A, Campus G, Domejean 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.
citation: Massara ML, Alves JB, Brandao PR. Atraumatic restorative treatment: clinical, ultrastructural and chemical analysis. Caries Res. 2002 Nov-Dec;36(6):430-6. doi: 10.1159/000066534.
citation: Bjorndal 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. doi: 10.1159/000262431.