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RESEARCH REPORT |
1 Department of Preventive Dentistry, School of Dentistry, University of Granada, Granada 18071, Spain;
2 School of Dentistry, Institute of Medical Science, University of Santiago de Cuba, Cuba; and
3 Odontologia Solidaria NGO, Spain;
* corresponding author, jllodra{at}hotmail.com.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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KEY WORDS: clinical trial • dental caries • preventive dentistry • silver diamine fluoride
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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We conducted a 36-month controlled clinical trial to evaluate whether the six-monthly application of a 38% SDF solution is effective to prevent and arrest caries in deciduous and permanent teeth of a sample of Cuban schoolchildren.
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MATERIALS & METHODS |
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The study included 452 schoolchildren of both sexes, none below 6 years of age, and all recruited from the "Colegio 26 de Julio" school. The study was approved by the Ethics Committee of the Institute of Medical Science of the University of Santiago de Cuba. The parents of all participants gave signed informed consent. Two previously calibrated examiners were responsible for all of the dental examinations. Each child underwent 7 examinations, one at baseline and then every 6 mos until the end of the study at 3 yrs. At each examination stage, we re-examined 10% of the schoolchildren to determine the intra-observer agreement. Inter-observer agreement was similarly tested, at baseline and at 1, 2, and 3 yrs. The schoolchildren were assigned on an individual random basis to the SDF or control group by a third researcher, ensuring that the examiners were blinded to the group of each child. Examinations were carried out at the school by an examiner using an explorer and flat mirror. In deciduous teeth, data were gathered for the surfaces of only canines and molars. In permanent teeth, data were gathered only on first molars. Each surface was classified as healthy, with active caries (presence of cavity with soft floor/walls), with inactive caries (cavity with hard floor/walls), filled, or absent. In the case of deciduous teeth, only those extracted for caries were considered absent. On healthy surfaces or those with inactive caries, the presence or absence of black stain was recorded. Teeth with an abscess, evidence of pulpal exposure, premature hypermobility, fissure, or abnormal coloring were considered non-vital. The treatment of each tooth (restoration, pulpal treatment, extraction) was also recorded at every examination.
The schoolchildren in the SDF group received, at the beginning of the study and every 6 mos thereafter, an application of 38% SDF solution (Fluoroplat, Laboratorios Naf, Buenos Aires, Argentina) on the decayed surfaces of deciduous teeth and the occlusal surfaces of any first permanent molars that had erupted. No attempt was made to remove decayed tissue from deciduous teeth. In first permanent molars with active caries, the soft surface layer of the decayed dentin was removed with excavators before the SDF solution was applied. The teeth were isolated from saliva with cotton rolls and then painted with the solution for 3 min, with the solution applied to one quadrant at a time. Three min after the application, the teeth were washed with a 30-second water spray.
Statistical Analysis
Sample size estimation was conducted with a 95% confidence interval and statistical power of 80%. Intra-observer and inter-observer agreements were measured with the Kappa test. The comparison of means was studied by the Student’s t test and multiple linear regression analysis. We used the chi-square (
2) test to study the distribution of children lost to follow-up and the distribution of black stain between the two groups. The significance level considered was 0.05. Analyses were performed with use of the SPSS statistical program (version 11.0).
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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0.93 at all examination stages, and Kappa values for inter-observer reliability were 0.92 at baseline (tested on 38 children), 0.94 at 12 mos (45 children), 0.89 at 24 mos (41 children), and 0.91 at 36 mos (47 children). In the 373 children followed up throughout the study, the mean baseline decayed, missing, and filled surface (dmfs) index scores were 3.68 ± 0.30 and 3.35 ± 0.26 in the SDF and control groups, respectively. The mean number of surfaces with active caries was 3.29 ± 0.28 in the SDF group and 2.91 ± 0.22 in the control group (Table 1
). At baseline, there were no statistically significant differences between the groups in dmfs score or number of surfaces with active caries. There were no significant differences in baseline dmfs or number of surfaces with active caries between the children lost to the follow-up and the group that completed the study (results not shown).
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), significant differences were observed between the groups in the mean of new decayed surfaces appearing during the study (Student’s t test, p < 0.001). The preventive fraction of SDF in deciduous teeth was 79.7%. The children in the SDF group had significantly more surfaces with inactive caries (Student’s t test, p < 0.05) and a higher percentage of black stains (97%), compared with the control group, in which only 48% of the inactive lesions were black (2 test, p < 0.001). There was no significant difference between the groups in mean number of non-vital deciduous teeth (Student’s t test, p = 0.65).
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), the control group showed a higher mean number of new decayed surfaces vs. the SDF group (Student’s t test, p < 0.001). The preventive fraction of the SDF group was 65% in first permanent molars. Compared with the controls, the SDF-treated children presented more surfaces with inactive caries (Student’s t test, p < 0.05) and a higher proportion of black stains in inactive lesions (2 test, p < 0.001). Throughout the study, only 5 first permanent molars with pulpal lesions were observed (2 in the SDF group and 3 in the control group), and no first permanent molar was extracted.
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).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS & METHODSRESULTSDISCUSSIONREFERENCES |
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The main aim of our study was to test the anti-caries efficacy of a six-monthly application of a 38% SDF solution in both deciduous teeth and first permanent molars. Both the preventive and therapeutic (possibility to arrest or reverse active caries) effects of this technique were analyzed. With respect to the prevention of new caries lesions, our SDF treatments showed a greater percentage of efficacy in deciduous teeth (around 80%) than in first permanent molar (65%) teeth. A recent Chinese study of deciduous incisors (Chu et al., 2002) reported a percentage of efficacy of 70–83%, depending on the clinical application protocol, similar to our results. In the present study, the baseline level of caries was much higher in deciduous teeth (mean of > 3 surfaces with caries) than in first permanent molars (0.3 surfaces with caries), which may explain the greater efficacy of the SDF solution in the deciduous dentition.
The application of fissure sealants is the most widespread model for the prevention of caries in first permanent molars. Llodra et al.(1993) published a meta-analysis that demonstrated a preventive fraction of 70% at 36 mos of follow-up. Our search of the literature disclosed no controlled clinical study based on the use of SDF in permanent teeth, although some clinical studies with small sample sizes have been published. Green (1989) reported that a solution of SDF + SnF2 was more effective in reducing caries in first permanent molars, compared with the application of SnF2 alone. Yamaga et al.(1972) studied 25 schoolchildren and found an 8% incidence of caries in SDF-treated first permanent molars, compared with 32% in controls, after a nine-month follow-up.
With respect to the therapeutic effect of SDF (arrest of caries), around 77% of treated caries that was active at baseline became inactive during the study, both in deciduous teeth and in first permanent molars. In the SDF group, practically all (97%) of inactive lesions presented black stain at the end of the follow-up. Yamaga et al.(1972) suggested that deposits of silver phosphate are the main action mechanism of SDF, responsible for the increased hardness and black staining. In relation to the desirability of removal of decayed dentin before the application, Chu et al.(2002) found no differences between SDF groups with or without prior excavation in deciduous teeth. No study has been published on the effects of the prior removal of decayed dentin in permanent teeth.
A hypothetical risk attributed to SDF is its possible toxicity to the pulp (Russo et al., 1989; Gotjamanos, 1996). This concern was not supported by the present results. On the contrary, there was a similar incidence of pulpal lesions between the groups, in both deciduous and permanent teeth. Some authors (Yamaga et al., 1972) have predicted reversible lesions in oral mucosa through inadvertent contact with SDF solution. This occurred in three patients in our study, with the appearance of a small, mildly painful white lesion in the mucosa, which disappeared at 48 hrs without treatment. The possibility of acute toxicity or the induction of fluorosis through the use of 38% SDF has been widely debated in the literature (Gotjamanos, 1997; Neesham, 1997). We applied the minimal amounts (4 mL to treat a mean of 80 quadrants), and special care was taken in the application, including abundant washing with water. Another proposed drawback of SDF treatment is the appearance of black stains, although in our view this is far outweighed by the caries-preventive benefits of SDF treatment.
There are no published recommendations for the frequency of SDF applications. Some authors applied the solution annually and others six-monthly. There is no documented evidence that starting treatment with multiple applications in a short period is preferable to starting with a single initial application. The application of a 38% SDF solution is a simple and low-cost method that does not require the cooperation of the patient or the complex training of the health professional. This approach may be of great utility as an alternative to more costly preventive methods in communities with limited resources. Its mechanism of action means that it can be useful to prevent and arrest caries in all teeth and surfaces. Wider studies of this treatment are required to investigate alternative protocols, different age groups, and high-risk groups, to evaluate longer-term outcomes, and to evaluate the efficiency of this approach, using more sensitive criteria for caries diagnosis.
The outcomes at 36 mos showed that the six-monthly application of a 38% SDF solution is efficacious to control caries in deciduous teeth. Our findings indicate that this approach is also efficacious to control caries in first permanent molars.
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ACKNOWLEDGMENTS |
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Received September 2, 2003; Last revision March 26, 2004; Accepted May 11, 2005
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REFERENCES |
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Gotjamanos T (1996). Pulp response in primary teeth with deep residual caries treated with silver fluoride and glass ionomer cement (atraumatic technique). Aust Dent J 41:328–334.[ISI][Medline]
Gotjamanos T (1997). Safety issues related to the use of silver fluoride in paediatric dentistry. Aust Dent J 42:166–168.[ISI][Medline]
Green E (1989). A clinical evaluation of two methods of caries prevention in newly-erupted first permanent molars. Aust Dent J 34:407–409.[Medline]
Klein U, Kanellis MJ, Drake D (1999). Effects of four anticaries agents on lesion depth progression in an in vitro caries model. Pediatr Dent 21:176–180.[Medline]
Llodra JC, Bravo M, Delgado M, Baca P, Galvez R (1993). Factors influencing the effectiveness of sealants: a meta-analysis. Community Dent Oral Epidemiol 21:261–268.[ISI][Medline]
McDonald SP, Sheiham A (1994). A clinical comparison of non-traumatic methods of treating dental caries. Int Dent J 44:465–470.[Medline]
Neesham DC (1997). Fluoride concentration in AgF and dental fluorosis (letter to editor). Aust Dent J 42:268–269.[ISI][Medline]
Russo M, Komatsu J, Takayama S, Holland C, Sundfeld R, Monteiro R (1989). Saforide: resposta pulpar sua aplicaço em dentina. Rev Odont UNESP 18:27–32.
Shimizu A, Kawagoe M (1976). A clinical study of effect of diamine silver fluoride on recurrent caries. J Osaka Univ Dent Sch 16:103–109.
Yamaga R, Nishino M, Yoshida S, Yokomizo I (1972). Diamine silver fluoride and its clinical application. J Osaka Univ Dent Sch 12:1–20.[Medline]
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