New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial

Juliana Mattos-Silveira, Isabela Floriano, Fernanda R Ferreira, Maria E F Viganó, M A Frizzo, Alessandra Reyes, Tatiane F Novaes, Caroline M Moriyama, Daniela P Raggio, José C P Imparato, Fausto M Mendes, Mariana M Braga, Juliana Mattos-Silveira, Isabela Floriano, Fernanda R Ferreira, Maria E F Viganó, M A Frizzo, Alessandra Reyes, Tatiane F Novaes, Caroline M Moriyama, Daniela P Raggio, José C P Imparato, Fausto M Mendes, Mariana M Braga

Abstract

Background: Approximal surfaces are a challenge to caries lesions control. Silver diamine fluoride (SDF) is a simple,low-cost and promisor intervention for arresting caries lesions, but it has never been tested on approximal surfaces. Our aim is to evaluate the efficacy and cost-efficacy of SDF in arresting initial lesions compared to resin infiltration and exclusively flossing (control group). Our second aim is to assess discomfort and satisfaction regarding interventions.

Methods/design: This is a randomized clinical trial, double-blinded, placebo-controlled study. Children/adolescents presenting at least one approximal initial caries lesion in primary molars/permanent premolars and molars will be included. Surfaces with advanced dentine lesions identified by radiography and participants who refuse to participate or present negative behaviors will be excluded. A minimum sample size of 504 surfaces will be required for each subgroup. Individuals will be randomly allocated in three groups of interventions: SDF, resin infiltration, and control group. Depending on the allocation, the patients will receive the active treatment and respective placebo therapies. All patients will be oriented to daily flossing the included surfaces. Our primary outcome will be caries progression by clinical and radiographic examinations. Appointments will be timed and costs of materials will be considered to calculate cost-efficacy. Patient discomfort will be assessed after interventions. Parent and patient satisfaction with the treatment will be collected after treatment and in the last follow-up visit. Individuals will be assessed at 1 and 3 months after treatment to evaluate dental biofilm and at 6, 12, and 24 months to assess caries progression by visual examination and/or radiography. Multilevel analyses will be used to verify if the type of treatment influenced on the tested outcomes. Costs will be compared and analyses of cost-efficacy will be performed. Poisson analysis will test the association between intervention and reported discomfort and satisfaction.

Discussion: Our hypothesis is that SDF is the most cost-efficacious option from all tested interventions. If our hypothesis is confirmed, the use of SDF in private and public contexts could represent an easier and effective option in the treatment of enamel approximal caries in children/adolescents.

Trial registration: ClinicalTrials.gov (NCT01477385), Initial release: 11/16/2011: last update: 06/02/2014.

Figures

Figure 1
Figure 1
CONSORT flow diagram of patient randomization.
Figure 2
Figure 2
Sequence of procedures performed for each recruited child/adolescent. *Active and placebo therapies may be performed in different order depending on the group. In the control group, the active treatment is the flossing and two placebo therapies will be performed.

References

    1. Cagetti MG, Campus G, Sale S, Cocco F, Strohmenger L, Lingström P. Association between interdental plaque acidogenicity and caries risk at surface level: a cross sectional study in primary dentition. Int J Paediatr Dent. 2011;21(2):119–125. doi: 10.1111/j.1365-263X.2010.01099.x.
    1. Seki M, Karakama F, Terajima T, Ichikawa Y, Ozaki T, Yoshida S, Yamashita Y. Evaluation of mutans streptococci in plaque and saliva: correlation with caries development in preschool children. J Dent. 2003;31(4):283–290. doi: 10.1016/S0300-5712(03)00033-2.
    1. Ashkenazi M, Bidoosi M, Levin L. Factors associated with reduced compliance of children to dental preventive measures. Odontology. 2012;100(2):241–248. doi: 10.1007/s10266-011-0034-1.
    1. Corby PM, Biesbrock A, Bartizek R, Corby AL, Monteverde R, Ceschin R, Bretz WA. Treatment outcomes of dental flossing in twins: molecular analysis of the interproximal microflora. J Periodontol. 2008;79(8):1426–1433. doi: 10.1902/jop.2008.070585.
    1. Merchant AT. Flossing for 2 weeks reduces microbes associated with oral disease. J Evid Based Dent Pract. 2009;9(4):223–224. doi: 10.1016/j.jebdp.2009.05.005.
    1. Hujoel PP, Cunha-Cruz J, Banting DW, Loesche WJ. Dental flossing and interproximal caries: a systematic review. J Dent Res. 2006;85(4):298–305. doi: 10.1177/154405910608500404.
    1. 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;81(11):767–770. doi: 10.1177/154405910208101109.
    1. 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. 2009;76(1):28–33.
    1. Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012;91(8):753–758. doi: 10.1177/0022034512452278.
    1. Tellez M, Gomez J, Kaur S, Pretty IA, Ellwood R, Ismail AI. Non-surgical management methods of noncavitated carious lesions. Community Dent Oral Epidemiol. 2013;41(1):79–96. doi: 10.1111/cdoe.12028.
    1. Phark JH, Duarte S, Jr, Meyer-Lueckel H, Paris S. Caries infiltration with resins: a novel treatment option for interproximal caries. Compend Contin Educ Dent. 2009;30 Spec No 3:13–17.
    1. Meyer-Lueckel H, Bitter K, Paris S. Randomized controlled clinical trial on proximal caries infiltration: three-year follow-up. Caries Res. 2012;46(6):544–548. doi: 10.1159/000341807.
    1. Paris S, Hopfenmuller W, Meyer-Lueckel H. Resin infiltration of caries lesions: an efficacy randomized trial. J Dent Res. 2010;89(8):823–826. doi: 10.1177/0022034510369289.
    1. Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012;91(3):288–292. doi: 10.1177/0022034511435328.
    1. Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41–46. doi: 10.1159/000275573.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, Group C. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008;148(4):W60–W66.
    1. Sonju Clasen AB, Ogaard B, Duschner H, Ruben J, Arends J, Sonju T. Caries development in fluoridated and non-fluoridated deciduous and permanent enamel in situ examined by microradiography and confocal laser scanning microscopy. Adv Dent Res. 1997;11(4):442–447. doi: 10.1177/08959374970110041001.
    1. Braga MM, Mendes FM, Ekstrand KR. Detection activity assessment and diagnosis of dental caries lesions. Dent Clin North Am. 2010;54(3):479–493. doi: 10.1016/j.cden.2010.03.006.
    1. 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;35(3):170–178. doi: 10.1111/j.1600-0528.2007.00347.x.
    1. Novaes TF, Matos R, Raggio DP, Imparato JC, Braga MM, Mendes FM. Influence of the discomfort reported by children on the performance of approximal caries detection methods. Caries Res. 2010;44(5):465–471. doi: 10.1159/000320266.
    1. Novaes TF, Matos R, Raggio DP, Braga MM, Mendes FM. Children’s discomfort in assessments using different methods for approximal caries detection. Braz Oral Res. 2012;26(2):93–99. doi: 10.1590/S1806-83242012000200002.
    1. 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;84(8):721–724. doi: 10.1177/154405910508400807.
    1. ICDAS-Committee . International Caries Detection and Assessment System (ICDAS II) Criteria Manual. Workshop held in Baltimore, Maryland, March 12th-14th 2005. Baltimore, MA: Committee ICDaASIC; 2005.
    1. Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988;14(1):9–17.
    1. Hämmerle CH, Jung RE, Sanz M, Chen S, Martin WC, Jackowski J, Multicenter study group Submerged and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. Clin Oral Implants Res. 2012;23(2):211–219. doi: 10.1111/j.1600-0501.2011.02210.x.
    1. Takanashi Y, Penrod JR, Lund JP, Feine JS. A cost comparison of mandibular two-implant overdenture and conventional denture treatment. Int J Prosthodont. 2004;17(2):181–186.
    1. Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010;19(7):512–516. doi: 10.1111/j.1532-849X.2010.00628.x.
    1. Stevenson M, Lloyd-Jones M, Morgan MY, Wong R. Non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol-related liver disease: a systematic review and economic evaluation. Health Technol Assess. 2012;16(4):1–174. doi: 10.3310/hta16040.
    1. WHO . Oral health surveys: basic methods. Geneva: WHO; 1997.
    1. Silness J, Loe H. Periodontal disease in pregnancy. ii. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand. 1964;22:121–135. doi: 10.3109/00016356408993968.
    1. Block PL, Lobene RR, Derdivanis JP. A two-tone dye test for dental plaque. J Periodontol. 1972;43(7):423–426. doi: 10.1902/jop.1972.43.7.423.
    1. Ekstrand KR, Bruun G, Bruun M. Plaque and gingival status as indicators for caries progression on approximal surfaces. Caries Res. 1998;32(1):41–45. doi: 10.1159/000016428.
    1. Greene JC, Vermillion JR. The simplified oral hygiene index. J Am Dent Assoc. 1964;68:7–13. doi: 10.14219/jada.archive.1964.0034.
    1. Bratthall D, Hänsel Petersson G. Cariogram – a multifactorial risk assessment model for a multifactorial disease. Community Dent Oral Epidemiol. 2005;33(4):256–264. doi: 10.1111/j.1600-0528.2005.00233.x.
    1. Ekstrand KR, Christiansen J, Christiansen ME. Time and duration of eruption of first and second permanent molars: a longitudinal investigation. Community Dent Oral Epidemiol. 2003;31(5):344–350. doi: 10.1034/j.1600-0528.2003.00016.x.
    1. Zero DT, Fontana M, Martinez-Mier EA, Ferreira-Zandona A, Ando M, Gonzalez-Cabezas C, Bayne S. The biology, prevention, diagnosis and treatment of dental caries: scientific advances in the United States. J Am Dent Assoc. 2009;140(Suppl 1):25S–34S. doi: 10.14219/jada.archive.2009.0355.
    1. Lo EC, Chu CH, Lin HC. A community-based caries control program for pre-school children using topical fluorides: 18-month results. J Dent Res. 2001;80(12):2071–2074. doi: 10.1177/00220345010800120901.
    1. Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries “silver-fluoride bullet”. J Dent Res. 2009;88(2):116–125. doi: 10.1177/0022034508329406.
    1. Mei ML, Chu CH, Lo EC, Samaranayake LP. Fluoride and silver concentrations of silver diammine fluoride solutions for dental use. Int J Paediatr Dent. 2013;23(4):279–285. doi: 10.1111/ipd.12005.
    1. Chu CH, Lo EC. Promoting caries arrest in children with silver diamine fluoride: a review. Oral Health Prev Dent. 2008;6(4):315–321.
    1. Peyron M, Matsson L, Birkhed D. Progression of approximal caries in primary molars and the effect of Duraphat treatment. Scand J Dent Res. 1992;100(6):314–318.
    1. Jiang H, Bian Z, Tai BJ, Du MQ, Peng B. The effect of a bi-annual professional application of APF foam on dental caries increment in primary teeth: 24-month clinical trial. J Dent Res. 2005;84(3):265–268. doi: 10.1177/154405910508400311.
    1. De Benedetto MS, Morais CC, Novaes TF, de Almeida RJ, Braga MM, Mendes FM. Comparing the reliability of a new fluorescence camera with conventional laser fluorescence devices in detecting caries lesions in occlusal and smooth surfaces of primary teeth. Lasers Med Sci. 2011;26(2):157–162. doi: 10.1007/s10103-010-0757-1.
    1. Fahy C, Costi D, Cyna A. Invasive 'placebo’ controls: have we lost sight of whom we are blinding? Paediatr Anaesth. 2011;21(11):1089–1091. doi: 10.1111/j.1460-9592.2011.03650.x.
    1. Mather M, Shafir E, Johnson MK. Remembering chosen and assigned options. Mem Cogn. 2003;31(3):422–433. doi: 10.3758/BF03194400.
    1. Ashkenazi M, Cohen R, Levin L. Self-reported compliance with preventive measures among regularly attending pediatric patients. J Dent Educ. 2007;71(2):287–295.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit