ORIGINAL RESEARCH

https://doi.org/10.5005/jp-journals-10015-2250
World Journal of Dentistry
Volume 14 | Issue 6 | Year 2023

Evaluation of 38% Silver Diamine Fluoride vs High Viscosity Glass Ionomer Cement for Management of Dentinal Caries in Primary Molars

Parika Vaid¹, Anil Gupta², Shalini Garg³, Shikha Dogra⁴, Shourya Tandon⁵, Ranu Rai⁶

^1-4,6Department of Pedodontics & Preventive Dentistry, Faculty of Dental Sciences (FDS), Shree Guru Gobind Singh Tricentenary University, Gurugram, Haryana, India

⁵Department of Public Health Dentistry, Faculty of Dental Sciences (FDS), Shree Guru Gobind Singh Tricentenary University, Gurugram, Haryana, India

Corresponding Author: Parika Vaid, Department of Pedodontics & Preventive Dentistry, Faculty of Dental Sciences (FDS), Shree Guru Gobind Singh Tricentenary University, Gurugram, Haryana, India, Phone: +91 9711195250, e-mail: paarikavaid02@gmail.com

Received on: 01 May 2023; Accepted on: 02 June 2023; Published on: 22 August 2023

ABSTRACT

Aim: To compare the effect of sealing dentinal caries [International Caries Detection and Assessment System (ICDAS) codes 4 and 5] by high viscosity glass ionomer cement (GIC) vs application of 38% silver diamine fluoride (SDF) in primary molars over a period of 6 months.

Materials and method: This study was conducted over a period of 6 months and included 50 primary molars with active dentinal occlusal lesions, aged 3–5 years, having ICDAS codes 4 and 5. Children were randomly assigned to group I: SDF application (n = 27) or group II: high viscosity GIC treatment (n = 23). Lesions were assessed clinically for any progression of caries extent by using International Caries Diagnosis and Assessment System II, topography of lesion and radiographically by International Caries Classification and Management System (ICCMS) criteria after 6 months of intervention compared to baseline. Further, the evaluation of SDF-treated lesion status was by lesion texture and GIC restoration status was evaluated by caries-associated restorations and sealants (CARS) criteria.

Results: After 6 months evaluation period, statistically significant, less progression of cases was observed in 7% of lesions after SDF application as compared to 39% in high-viscosity GIC group. Chairside time was statistically significant in between both the groups (p-value = 0.039).

Conclusion: Techniques with minimal intervention, namely 38% SDF and high viscosity GIC for the occlusal surface cavity, appear to be effective in arresting the progress of dentinal caries in primary teeth.

Clinical significance: Silver diamine fluoride (SDF) application stops the progression of dentinal lesions with less chairside time, being economical and can be used in patients of uncooperative behavior, including those with special healthcare needs.

How to cite this article: Vaid P, Gupta A, Garg S, et al. Evaluation of 38% Silver Diamine Fluoride vs High Viscosity Glass Ionomer Cement for Management of Dentinal Caries in Primary Molars. World J Dent 2023;14(6):486-491.

Source of support: Nil

Conflict of interest: None

Keywords: Deciduous teeth, Dentin caries, Glass ionomer cement, Silver diamine fluoride.

INTRODUCTION

Minimally invasive procedures in dentistry offer a substitute to manage dental carious lesions on the tooth in a better, more conservative and more effective way, bringing about greater maintenance of tooth structure, and stopping the development of cariogenic biofilm.¹^,² The caregivers and children will accept these caries management approaches in pediatric dentistry as they should be cost-effective and has the least possible distress to the child.³ Therefore, to provide standard care for managing carious lesions for reducing discomfort during the treatment, nonrestorative caries treatment, also named nonrestorative cavity control (NRCC), is the most recent concept involving no caries removal.⁴ The aim of nonrestorative, noninvasive and microinvasive caries treatment is to bring about the process of carious disease at a lesion level, reducing the damage of sound tooth anatomy and dental caries arrest that can encounter the necessity of oral health objectives globally due to the notable returns like reasonable cost and ease to implement treatment.⁵^-⁷ These NRCC approaches are mainly for providing treatment to patients with uncooperative behavior, immature cognitive functioning, disability, or any other medical conditions.⁸^-¹⁰ In 2017, the American Academy of Pediatric Dentistry documented a guideline for the use of silver diamine fluoride (SDF) for dental caries management in children and adolescents, including those with special healthcare needs. The introduction of 38% SDF has an easy application and noninvasive management of dental caries. It is a clear liquid having silver’s antibacterial effects and fluoride remineralization effects, which is a good beneficial agent for the management of dental caries in cooperation with difficult pediatric patients.¹¹^-¹³ The mechanism of arrest by SDF occurs by twin act of fluoride and silver. The bactericidal “zombie effect” of silver interferes with biofilm and loss of mineral content, whereas fluoride inhibits biofilm and facilitates apatite nucleation in addition to remineralization. SDF occludes dentinal tubules and prevents invasion and acid diffusion.¹⁴^,¹⁵ Dentin treated with SDF improved resistance to collagenase and trypsin. Hence, preventing demineralization and arrest of carious lesions.¹⁶^,¹⁷ Another well-accepted minimal intervention approach for managing cavitated carious lesions in both clinical and community settings is the atraumatic/alternative restorative technique (ART), and the high viscosity glass ionomer cement (GIC), a new-generation glass ionomer formulation is the gold standard for ART. The remineralization enhancement of hard tooth tissue and secondary caries prevention is mainly due to high fluoride release. They associate directly with the enamel and the dentin by attaining a chemical bond with hard tooth tissue because of their chemical composition. The high-viscosity GIC has better properties, like upgraded usage characteristics, reduced setting time, an increase of strength, and improved resistance to wear, which makes GIC the choice of material. It also has the additional property of bonding chemically onto the moist surface and providing a seal to enhance remineralization at the tooth restorative interphase.¹⁷ Because of their increased level of fluoride release and their effortless manipulation, the highly viscous GIC can be recommended, especially in children with high caries risk and in uncooperative children having carious lesions in their primary teeth.¹⁷^,¹⁸ Tensile strength, compressive strengths and adhesion to dentin and enamel appear to be superior to those of traditional GIC.¹⁸ These minimally invasive procedures offer a feasible management approach to preserve teeth using fewer tools and are also easy to implement with very minimum equipment and resources that reduce the load of oral health expenses. Due to limited literature on the comparison of both interventions and for evaluation of better choice of material in children with uncooperative behavior and special healthcare needs, this study was conducted to compare the effectiveness of high viscosity GIC and 38% SDF to evaluate postoperative caries arrest, or progression of International Caries Detection and Assessment System (ICDAS) score clinically and radiographically at 6 months as well as evaluation of chairside time and patient cooperation during the intervention.

MATERIALS AND METHODS

Study Design

This randomized clinical trial, a single-blinded study, was conducted at the Department of Pediatric and Preventive Dentistry, Gurugram, Haryana, in the period of November 2021–2022. A total of 50 primary molars having initial carious lesion with ICDAS II codes 4 and 5 in preschool children between 3 and 5 years of age were allocated into two groups (group I: SDF and group II: GC IX) after informed consent from the parents/guardian for the participation of children. The participants were allocated in a 1:1 ratio following the Consolidated Standards of Reporting Trials recommendation, as shown in Flowchart 1. The participants and their parents/guardians were not aware of patient allocation.

Flowchart 1: Schematic representation of study design

Ethical Clearance and Clinical Trial Registration

The ethical clearance was obtained from the Ethical Committee of the institution, and the trial was registered under the Clinical Trial Registry of India (Clinical Trials Registry India/2021/05/033876).

Case Selection

Children of age 3–5 years were screened as per inclusion and exclusion criteria (mentioned below) in routine dental OPD. A total of 90 primary molars (minimum one) with initial dentinal caries using ICDAS II scoring criteria were evaluated, out of which 50 were selected with the parent’s consent to participate and allocated to group I (SDF, n = 27) and group II (GC IX, n = 23). For selected tooth samples at first visits, preoperative bitewing, or IOPA radiograph was taken to assess caries extension.

Inclusion Criteria

Preschool children between the age-group of 3 and 5 years.
Patients with initial dentinal caries in primary molars, that is, ICDAS codes 4 and 5.¹⁹
The ICDAS’s ICCMS radiographic criteria with scoring ranging from RA3 (outer one-third dentin) to RC5 (inner one-third dentin).²⁰

Exclusion Criteria

Children suffering from any systemic or severe chronic disease and allergy.
Healthy children with carious primary posterior teeth ranging above score 5 as per ICDAS II scoring criteria of the carious lesion.
The ICDAS’s ICCMS radiographic criteria with scoring RC6 (Into pulp)
Clinical signs of pulpal and periapical pathology.
Tooth near exfoliation.

Methods

A baseline clinical examination was performed under artificial light using the visual-tactile method, and radiographs were taken to assess the extent of the carious lesion. A carious lesion was recorded as active if the tooth surface was soft on gently drawing the probe. No effort was made to remove caries/unsupported enamel for caries treatment in both groups. The intervention and follow-up analysis was performed by the same examiner who did the baseline clinical examination. In group I, teeth with carious dentin were treated with 38% SDF and in group II were treated with GC IX restoration.

Outcome Analysis

Lesions treated in both groups were evaluated at 6 months follow-up on the basis of ICDAS II score and radiographic extent of caries. The SDF group lesions were also examined on lesion texture, and the GC IX group was evaluated for retention status of restoration.

Interventions

Group I: SDF

The treatment of the selected tooth sample with initial dental caries (ICDAS II codes 4 and 5) was as follows: gross debris was removed from the cavitation of the tooth surface to be treated, and protective coating (vaseline) was applied to the patient’s skin and gums to avoid staining. No effort was done to remove dental caries. The tooth was isolated with cotton rolls and a saliva ejector. The surface was dried with a three-way syringe. One drop of 38% SDF (e-SDF, Kids-e-Dental, Santacruz West, Mumbai, India) was applied directly on the affected tooth surface with a micro brush applicator tip for 3 minutes, as per the manufacturer’s instructions. The excess SDF was removed with cotton pellets or cotton rolls to minimize systemic absorption. A gentle flow of compressed air was applied until the medicament was dry. The patient was advised not to eat food or drink water for a minimum of 45 minutes.²¹

Group II: High-viscosity GIC (GC IX)

For the selected tooth sample with initial dental caries (ICDAS II codes 4 and 5), the carious tooth surface was cleaned with water and air-dried gently. No effort was done to remove dental caries. For standard consistency as recommended by the manufacturer (GC Gold Label IX, Tokyo, Japan), mixing was done by taking 1 full measuring spoon (at level) of powder to 1 drop of liquid. Powder and liquid were mixed with a plastic spatula on a mixing pad. For a standard mix, half powder was added to the liquid and was mixed for at least 10 seconds till reaching a milky constant state. Then the remaining powder was added and mixed for 20 seconds to achieve an even mix. The mixture was then applied to the cavitated area using a filling instrument. The patient was advised not to eat food or drink water for a minimum of 45 minutes.²²

Follow-up Evaluation

Visual and tactile inspection was done at follow-up visits. Occurrence or lack of pain in the follow-up visit was evaluated by verbal questions, and if any failures in the respective groups, they were treated by other alternative restorative interventions based upon clinical assessment of the study tooth sample by macroscopic analysis and ICDAS II scoring criteria in postoperative follow-up visits as follows.

At Baseline Examination

At baseline examination following parameters were evaluated:

Clinical evaluation: The carious lesion in both groups was evaluated by ICDAS II codes 4 and 5.
Radiograph evaluation: It was done with preoperative bitewing or IOPA radiograph for both the groups to assess caries extension.

Follow-up at 6 Months

Clinical Evaluation and Radiographic Evaluation

In group I (SDF), the treated tooth sample was clinically assessed and evaluated as per parameters of surface texture (hard and soft) by running the tip of sharp explorer, increase in the carious lesion and ICDAS II scoring criteria by visual examination. Bitewing or Intraoral periapical radiograph (IOPA) radiograph was taken at six monthly visits for evaluation of arrest or progression of caries lesion with respect to preoperative bitewing or IOPA radiograph taken at initial screening (Fig. 1).

Figs 1A to D: (A) Preoperative clinical photograph of SDF (group I) ICDAS II code 5 wrt 75; (B) Postoperative (6 months) clinical photograph of SDF application wrt 75; (C) Preoperative radiograph of SDF group showing ICCMS/ICDAS code RB4 (middle one-third dentin) caries extent; (D) Postoperative radiograph of SDF group showing ICCMS/ICDAS code RB4 (middle one-third dentin)

In group II (high-viscosity GIC) treated tooth sample was evaluated by ICDAS II scoring criteria visually and further on retention of HVGIC by using caries-associated with restorations and sealants (CARS) criteria. Bitewing or IOPA radiograph was taken at 6 months visit for evaluation of progression of caries lesion with respect to preoperative bitewing or IOPA radiograph taken at initial screening (Fig. 2).

Figs 2A to D: (A) Preoperative clinical photograph of GC IX (ICDAS II code 5) wrt 84; (B) Postoperative (6 months) clinical photograph showing GC IX restoration wrt 84; (C) Preoperative radiograph of GC IX group showing ICCMS/ ICDAS code RC5 (inner one-third dentin) caries extent; (D) Postoperative radiograph of GC IX group showing ICCMS/ICDAS code RB4 (middle one-third dentin)

Statistical Analysis

The collected data were entered into Microsoft Excel and then transferred to Statistical Package for the Social Sciences version 22.0, released in 2013; Armonk, New York, International Business Machines Corporation, was used to perform the analysis.

Descriptive Statistics

Since the outcome was categorical data, it was presented in the form of proportion, and the Chi-squared test and Fischer exact test were used for the test of significance to compare the status of caries arrests between the two groups. Intragroup analysis was done by t-test. The level of significance (p-value) will be set at p < 0.05. And any other relevant test, if found appropriate during the time of data analysis, was dealt with accordingly.

RESULTS

A total of 50 active occlusal dentinal carious lesions in children of age 3–5 years were selected after examination based on inclusion and exclusion criteria and allocated into two intervention groups (SDF and GC IX). At baseline and 6 months follow-up visit, clinical evaluation of the ICDAS score was done by the ICDAS II, and radiographic evaluation was assessed by ICDAS/ICCMS radiograph scoring system.

Clinical Evaluation

Baseline

There were no statistically significant values observed at baseline in relation to the ICDAS score in between both the groups (p = 0.828). According to the topography of the lesion, the most commonly involved carious surface was occlusodistal in both groups, with ap-value of 0.46. No statistically significant differences were observed in radiographic extent in comparison of both groups with baseline data (p = 0.463).

Follow-up

In relation to the ICDAS score, 7.4% (2/27) lesions had increased in the SDF group, and 39.1% (9/23) lesions increased in the GC IX group at the 6-month follow-up visit. A statistically significant difference was found in the ICDAS score (p = 0.017) (Table 1). The success rate in relation to lesion texture of SDF (group I) was 70% with a failure rate of 30% (Table 2), whereas the restoration failure rate of the GC IX group was 39.1% in relation to progression of carious lesion according to caries associated with restorations and sealants (CARS) criteria (Table 3). The mean chair side time was 4.28 minutes in SDF and 7.66 minutes in the GC IX group. A statistically significant difference was found in chair-side time between both groups (p = 0.039). In context to a radiographic carious extent, the SDF group had 7.4% (2/27) lesions increased, and the GC IX group had 4.3% (1/23) lesions increased at 6 months follow up with non-significant p-value of 0.268 (Table 1).

**Table 1:** ICDAS score and radiographic criteria at 6 months in SDF and GC IX group
Treatment	ICDAS Score		Radiographic criteria
Treatment	Increased	Same	Increased	Same
SDF group (n = 27)	2/27 (7.40%)	25/27 (92.5%)	2/27 (7.40%)	25/27 (92.5%)
GC IX group (n = 23)	9/23 (39.1%)	14/23 (60.86%)	1/23 (4.34%)	22/23 (95.6%)

p value shows significant results (0.017); aonly denotes the statistical significance

**Table 2:** Intragroup assessment of lesion texture in the SDF group at 6 months
Lesion texture	Frequency (%)
Soft	8 (29.6%)
Hard	19 (70.4%)^a
Total	27 (100%)

Bold number shows the achieved success result with “a” denoting significance

**Table 3:** Intragroup assessment of caries associated with restoration and sealants CARS criteria at 6 months in GC IX group
CARS criteria	No. of participants (%)
Sound restoration (score 1)	1 (4.3%)
First visual change (score 2)	4 (17.4%)
Distinct visual change (score 3)	7 (30.4%)
Caries adjacent to restoration with dentinal shadow (score 4)	0 (0%)
Distinct visual change with <0.5 mm caries (score 5)	2 (8.7%)
Extensive cavity (score 6)	9 (39.1%)^a
Total	23 (100%)

Bold numbers show maximum failure result with “a” denoting significance

The overall outcome of statistical analysis shows that the SDF arrest rate or progression of carious lesions was better as compared to GC IX in terms of ICDAS score and lesion texture. Whereas failure rate was more in retention of restoration causing lesion progression.

DISCUSSION

The noninvasive and minimally invasive techniques application have minimized the necessity for traditional restorations.²³ Children’s oral and general well-being are affected by dental caries throughout their lives.²⁴ Tooth structure loss associated with conventional cavity preparation methods has resulted in parent’s attitude being reluctant to seek dental treatment and more adoption of minimum intervention dentistry (MID) by guided education as these approaches also emphasize the maximum conservation of healthy tooth structure, aiding caries arrest without complete decay excavation and preserve affected dentin that can be remineralized.²⁴ These approaches have reduced the risk of pulp exposure and yield results comparable to traditional treatment in terms of clinical outcomes and restoration longevity, found to be less time-consuming and associated with less intraoperative dental anxiety and discomfort, hence proven to be more cost-effective in the long term.²⁵^,²⁶ In the context of conventional restorative methods, MID requires minimal equipment and highly trained dental health personnel. NRCC can be a preferred approach to manage initial dentinal caries, especially in children from under-aided parts of the world where facilities are limited, young patients, uncooperative patients, patients with exceptional healthcare requirements, and situations in which traditional cavity preparation and/or placement of traditional dental restorations are not feasible. Clinical case selection is important for the success of NRCC. So far, the International Caries Detection and Assessment System (ICDAS) II scoring criteria have been found to be accurate and reproducible in the diagnosis of early carious lesions and for long-term evaluation.

World Health Organization (2021) included SDF as one of the most efficacious, safe, and cost-effective medicines for meeting the most important needs in a health system for adults and children. SDF is inexpensive, can be applied without the removal of infected soft dentin and provides an effective treatment alternative in patients with behavioral problems and severe dental anxiety, medically delicate patients comprising those going through or having undergone radiation therapy and young precooperative children who need management under general anesthesia.²⁷^,²⁸ SDF use has a caries-prevention effect and drops the incidence of new lesions. BaniHani et al. review suggests the caries arrest rate after a single application of 38% SDF ranged between 31 and 79%; the biannual application has significantly increased the carries arrest rate to 53 and 91%.

For the management of dental caries, especially in preschool uncooperative children, GIC has been a gold standard for decades. To remove decayed areas of the tooth before filling, conventional approaches (drill and fill) need highly trained dental health recruits, access to electricity, and proper tools and are costlier. Nowadays, high viscosity GIC Fuji IX is used as a noninvasive approach which is a painless and cost-effective technique that produces lesser dental anxiety, has high acceptance in pediatric patients, produces a better seal, and changes the damaged tooth tissue. It has been found to be a biocompatible material that chemically adheres to enamel and dentin, hinders enamel demineralization, and has a slighter potential to induce recurrent caries.²⁹ This esthetic restoration avoids diffusion of acids from biofilm into the dental carious lesion and thereby causing caries arrest by loss of minerals. This is a preferable approach for an outreach team to deliver dental care in a field setting with limited resources. De Amorim et al. and Saber et al. reviewed and reported that single-surface restorations of high viscosity GIC Fuji IX in primary teeth had a high survival rate of 93% and, therefore, can be used in clinical practice.²²

A statistically significant result was found in intragroup assessment in both groups (p = 0.001). Jiang et al. state that 80% of caries arrests were observed after 6 months’ application of SDF.³⁰ The causes of failure (7%) can be due to the application of SDF at only 6 months and not biannually, error in clinical and radiographic assessment at case selection, patient negligence in maintaining proper oral hygiene, and operator error in maintaining isolation. Reapplication of SDF solution, at least yearly, may be necessary to maintain and enhance its efficacy in arresting dentine caries.³¹ Mabangkhru and Duangthip suggest that the SDF reapplication, at least bi-annually, might be essential in maintaining and enhancing in arresting dentine caries effect. Cleary et al. conducted a randomized clinical trial in primary molars with ICDAS 5 and 6 and stated that at 1 year, lesions treated with SDF had minor failures and major failures more than restorative treatment.

The cause of 39% failure can be poor oral hygiene, young age children in the current study (lower level of ability to maintain patience and to cooperate with the dentist during the dental restorative procedures), error in proper isolation which leads to failure between bonding of restorative material to the tooth surface, cervical borderline gaps, total or partial dislodged restorations, and gross marginal deficiencies. GIC restorations were established to produce better results when used in combination with a dentin conditioner.³²

Abdellatif conducted a study on ICDAS II scores 4, 5, or 6 primary teeth and established that SDF and high viscosity GIC are equally effective in primary teeth caries arrest and statistically significant difference in chair side time between both groups.³² Sharma et al. state that the experimental effectiveness of SDF in arresting caries in relation to ICCMS scores at different interims was found to be non-significant (p > 0.05) at different time intervals.³³^,³⁴

Limitations of this study were that plaque accumulation has a negative effect on the success of caries arrest treatment regardless of the fluoride treatment protocol and extent of caries lesion. Maintaining good plaque control in the management of dental caries in young children has the utmost importance. Other issues, such as surface and tooth type must be reviewed when predicting the success of fluoride treatment. The sample size should be increased to assess the proper success or failure of interventions, and long-term follow-up should be done.³⁴^,³⁵

CONCLUSION

The objective of nonrestorative or noninvasive and microinvasive caries treatment can minimize the loss of sound tooth anatomy by arresting dental caries and managing the caries disease process at a lesion level. The introduction of 38% SDF has easy application and noninvasive management of dental caries. High-viscosity GIC (new generation formulation) has resulted in better properties of upgraded usage characteristics, lessened setting time with better strength, and improved resistance to wear, which makes GICs the choice of material.³⁵

Clinical Significance

The clinical importance of considering these techniques for the management of carious primary teeth is to make it a majority option than a compromised alternative in situations wherever the conventional method is unlikely due to the patient’s cooperation or cost.³⁵ Even though no statistically significant difference was suggested, SDF has several advantages to offer. In pediatric patients with less cooperation, in teeth with incomplete eruption where isolation is difficult to achieve and in situations in which there is uncertainty regarding the stage of pulp degeneration, SDF is a better option than ART. It reduces the need for complex treatments, especially when patients are awaiting specialist care.³⁶

Additionally, low cost and shorter chair time when compared with ART make SDF an effective alternative for preschool children and in community health plans. The fluoride release by GIC is very less when compared with 38% SDF (44800 ppm fluoride), which inhibits progression only in incipient caries.³⁵ Another shortcoming is the comparatively low retention rate of restorations in minimally invasive procedures and caries progression in areas where restoration is dislodged. The Fuji IX costs almost 20 times more than SDF is a major drawback of this approach.³⁶

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