Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

NCT ID: NCT01508611

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-08-31

Brief Summary

This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of patients and responsible for the application of the solution cariostatic.

Detailed Description

The sample will be comprised of 183 patients between 4 to 7 year-old, who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3). Patients will be randomly allocated to treatments, according to the technique to be employed: (I) 30% diamine silver fluoride, (II) cross-toothbrushing technique. Will also be guided and motivated individual, where these children will be taught the technique of brushing conventional. It will be given to all patients a toothbrush. In times of reassessment, the degree of wear of the bristles of these brushes will be evaluated in order to infer the use of the same. The teeth will be evaluated by clinical and exams at baseline and after 3, 6, 12, 18 and 24 months.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

30% silver diammine fluoride

The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied in erupting molars with a disposable microbrush for 3m. Then the surface will be washed for 30s.

Group Type: ACTIVE_COMPARATOR

30% silver diammine fluoride

Intervention Type: OTHER

The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.

Anteroposterior toothbrushing technique will be explained to the children.

cross-toothbrushing

Children will be oriented to proceed cross-toothbrushing in erupting molars

Group Type: ACTIVE_COMPARATOR

Oral hygiene

Intervention Type: BEHAVIORAL

With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique

Interventions

30% silver diammine fluoride

The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.

Anteroposterior toothbrushing technique will be explained to the children.

Intervention Type: OTHER

Oral hygiene

With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique

Intervention Type: BEHAVIORAL

Other Intervention Names

Cariestop; Biodinamica; Toothbrush

Eligibility Criteria

Inclusion Criteria

• erupting permanent molars (that are not in full occlusion)
• not special children
• children who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3)

Exclusion Criteria

• presence of cavitated caries lesions
• presence of enamel defects (hypoplasias)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mariana Minatel Braga

PhD, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana M Braga, PhD

Role: PRINCIPAL_INVESTIGATOR

USao Paulo

Locations

Universidade de Sao Paulo

São Paulo, , Brazil

Countries

Brazil

References

Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.

Reference Type: BACKGROUND

PMID: 19341576 (View on PubMed)

Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.

Reference Type: BACKGROUND

PMID: 12407092 (View on PubMed)

Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35. doi: 10.2341/06-63.

Reference Type: BACKGROUND

PMID: 17555173 (View on PubMed)

Ekstrand KR, Ricketts DN, Kidd EA, Qvist V, Schou S. Detection, diagnosing, monitoring and logical treatment of occlusal caries in relation to lesion activity and severity: an in vivo examination with histological validation. Caries Res. 1998;32(4):247-54. doi: 10.1159/000016460.

Reference Type: BACKGROUND

PMID: 9643366 (View on PubMed)

Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

Reference Type: BACKGROUND

PMID: 17518963 (View on PubMed)

Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.

Reference Type: BACKGROUND

PMID: 16040729 (View on PubMed)

Yee R, Holmgren C, Mulder J, Lama D, Walker D, van Palenstein Helderman W. Efficacy of silver diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009 Jul;88(7):644-7. doi: 10.1177/0022034509338671.

Reference Type: BACKGROUND

PMID: 19641152 (View on PubMed)

Other Identifiers

SDFtrials-02

Identifier Type: -

Identifier Source: org_study_id