Clinical effectiveness of ion-releasing restorations compared to composite restorations in pediatric dental treatments: a systematic review and meta-analysis

Background: The choice of restorative material in pediatric dentistry is clinically relevant for ensuring long-term tooth preservation and reducing recurrent caries. This systematic review and meta-analysis compared the clinical effectiveness of ion-releasing restorations (IRR) and composite resin (CR) in children's dental treatments.

Methods: Randomized clinical trials with ≥1-year follow-up were identified through comprehensive searches in PubMed, Cochrane Library, Scielo, Scopus, Web of Science, and Google Scholar up to January 2024. Studies reporting clinical outcomes of IRR vs. CR were analyzed. Risk of bias was assessed using RoB2.0, and evidence certainty with GRADE.

Results: Of 1,109 records screened, nine trials were included. Pooled analyzes showed no statistically significant differences between IRR and CR regarding secondary caries, marginal adaptation, or restoration survival (p > 0.05). Both materials demonstrated satisfactory longevity and clinical behavior.

Conclusions: Within the limitations of available evidence, ion-releasing and composite restorations provide comparable clinical performance in pediatric dentistry. The findings support the use of IRR as a reliable alternative for child patients, offering bioactive benefits while maintaining similar restorative success to composites.

Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024524163, PROSPERO CRD42024524163.

1 Introduction

Dentistry always seeks to improve the quality of restorative interventions to ensure long-lasting results with essential attributes such as durability, aesthetics and biocompatibility (1). The durability and resistance of restorations are essential to cope with chewing forces and variations in the oral environment (2), especially in contexts where dental caries remains a widespread health problem (3). Aesthetics are crucial, as patients value the appearance of restorations (4), and biocompatibility with surrounding tissues also influences the choice of material (5).

In recent years, there have been significant advances in composite resin (CR) formulations to address clinical challenges. Bulk placement techniques, new filler formulations, and simplified adhesion protocols have facilitated their application (6–8). However, clinical problems such as sensitivity of the technique, polymerization shrinkage, and lack of antibacterial properties still persist (9–11). Furthermore, the main reasons for its failure continue to be secondary caries and bulk fractures (6, 7, 12).

For this reason, intelligent and alternative restorative materials have been developed (13–15). Ion-releasing restorative (IRR) materials, such as glass ionomer cement (GIC), are known for their fluoride-releasing properties, which contribute to preventing caries and maintaining biocompatibility (16–18). However, marginal adaptation and resistance un-der load are important aspects to consider (19, 20). The CRs are a popular choice for es-thetic restorations, offering a wide range of shades and good marginal adaptation (21–23). Although they are sensitive to moisture and may experience wear, they provide excellent aesthetics and durability in appropriate situations (24, 25).

The choice between IRR and CR depends on specific clinical needs, prioritizing caries prevention and biocompatibility with IRR (26, 27), while for CR aesthetics and durability are prioritized (1). Other factors such as costs and ease of application also influence the decision of the most appropriate restorative material for each case (28).

Therefore, the purpose of this systematic review and meta-analysis is to compare the clinical effectiveness of IRRs vs. CRs in pediatric dental restorations. We hypothesized that ion-releasing restorations would demonstrate comparable or superior clinical performance to composite restorations in pediatric dental treatments.

2 Materials and methods

2.1 Protocol and registration

The present review was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) (29) and registered in the Prospective Registry of Systematic Reviews (PROSPERO) (30). The registry is publicly available under CRD number 42024524163.

2.2 Definitions of interventions

• Ion-Releasing Restorations (IRR): IRR were defined as restorative materials capable of releasing therapeutic ions, primarily fluoride, and included conventional glass ionomer cements (GIC), resin-modified GIC (RMGIC), high-viscosity GIC, glass hybrids, compomers (polyacid-modified composites), and giomers. Materials were included only if their ion-releasing capacity was stated by the manufacturer or verified in the study protocol.

• Composite Resins (CR): CRs referred to light-cured resin-based materials with no inherent ion-releasing properties, used as control or comparison arms in eligible studies.

2.3 Focused question and PICO framework

The focused question was formulated using the PICO format (population, intervention, comparison and outcomes), as detailed below:

- Population: Children who received dental restorations.

- Intervention: Restoration with IRRs, which includes all GIC derivatives (RMGIC, HV-GIC, conventional and glass hybrid), polyacid-modified composites (compomer), giomer, and any material declared by the manufacturer to have the ability to release ions.

- Comparison: Restoration with CR.

- Outcomes: Retention, marginal adaptation, marginal discoloration, marginal or tooth integrity, secondary caries, color or translucency, surface texture or luster, surface staining, wear, anatomic form, post-operative sensitivity, periodontal tissue, integrity of contact point, occlusion.

Focused question (PICO): Is there a difference in the clinical effectiveness of ion-releasing restorations com-pared to resin composite in pediatric dental restorations?

2.4 Information sources and search strategy

For the present systematic review, a systematic search was carried out in five electronic databases (PubMed, Cochrane Library, Scopus, Web of Science, and Scielo). Gray literature was also consulted through Google Scholar, OpenGrey, and Proquest. Addition-ally, the reference lists of included studies were reviewed; all until January 2024; combining keywords and subject titles according to the thesaurus of each data-base: “ion-releasing”, “bioactive resin composite”, “glass ionomer cement”, “high viscosity glass ionomer”, “resin modified glass ionomer”, “glass hybrid”, “polyacid-modified composite”, “compomer”, “resin composite”, “composite resin”, “randomized clinical trial” and “clinical trial”. The search strategies for each of the databases are found in Table 1.

Table 1

Table 1. Search and selection of studies.

Additionally, further relevant literature was included after a hand search of the reference lists of the final articles.

2.5 Study selection

The search in the electronic database was carried out by two authors (HA and FCO) independently, and the final inclusion decision was made according to the following criteria: Randomized clinical trials (RCTs), with a follow-up time greater than or equal to 1 year, without time and language limits, report the clinical effectiveness of the IRR and CR in pediatric dental restorations (I, II and V Class) using the World Dental Federation (FDI) or the United States Public Health Service Criteria (USPHS) as evaluation criteria. Articles that were prospective studies, unpublished studies, and reported in more than one publication with different follow-up periods were excluded.

2.6 Data extraction

A predefined table was used to extract data from each eligible study, including: author(s), year of publication, study design, country where the study was conducted, number of patients, proportion of male and female patients, age mean and age range, follow-up time, evaluation criteria, study groups, number of patients and teeth restored per study group, type of cavity (according to Black), tooth type, Retention, marginal adaptation, marginal discoloration, marginal or tooth integrity, secondary caries, color or translucency, surface texture or luster, surface staining, wear, anatomic form, post-operative sensitivity, periodontal tissue, integrity of contact point and occlusion. From each eligible study, two investigators (FCZ and LAR) independently extracted information, and all disagreements were resolved by discussion with a third reviewer (LAJ).

2.7 Risk of bias (RoB) assessment

The RoB of the included studies was independently assessed by two calibrated authors (FCO and SZ) (k = 0.98) using the Cochrane Group's RoB 2.0 tool (31) and all disagreements were resolved by discussion with a third reviewer (HA). According to this tool, clinical trials are evaluated in 5 domains: randomization process, deviations from planned interventions, missing outcome data, outcome measurement, and selection of the results report; to later be classified as: high risk of bias, bias with some concerns, or low risk of bias.

2.8 Statistical analysis and certainty of evidence (GRADE)

Data from each study were entered and analyzed in RevMan 5.3 (Cochrane Group, UK); using measures such as mean, standard deviation, and frequency in a random effects model with a 95% confidence interval. Additionally, a GRADE analysis was performed using the guideline development tool (GRADEPro GDT) (McMaster University and Evidence Prime Inc., Canada).

3 Results

3.1 Selection of studies

The electronic and manual search strategies yielded a total of 1,109 articles, excluding 347 duplicates (Figure 1) and 751 were excluded during title screening, leaving 17 potentially eligible for abstract screening, but 11 articles were excluded and 3 added from other reviews, resulting in 9 RCTs for full-text article screening, and they met the eligibility criteria for qualitative and quantitative synthesis (meta-analysis). The reasons for the exclusion of the studies are found in Table 2.

Figure 1

Figure 1. PRISMA diagram showing the process of inclusion and exclusion of studies.

Table 2

Table 2. Reason for exclusion of studies.

3.2 Characteristics of included studies

In total, 9 RCTs (43–51) were included, of which only two (45, 47) were parallel. All studies reported that the total number of patients ranged from 26 to 180 and the number of teeth treated ranged from 16 to 176. Six studies (43, 45, 46, 48–50) reported that the mean age of patients ranged from 5.08 to 8 years, and all studies reported a range of 4–11 years in all patients with a follow-up time of between 1 year and 2 years (Table 3).

Table 3

Table 3. Characteristics of included studies.

The countries where the studies were carried out were: Turkey (43, 44, 46, 47, 50), Greece (45), Sweden (49), Brazil (48) and China (51). Two studies (46, 47) mentioned that the evaluation criteria used for the analysis of the teeth was the FDI criteria. Five studies (43, 46–48, 51) reported the use of polyacid-modified resin-based composite (PMRC) or compomer, one study (47) used giomer, one study (44) reported the used bulk-fill composite, one study (44) used glass ionomer cement (GIC), one study (50) used high viscosity glass ionomer cement (HVGIC) and four studies (45–47, 49) used resin-modified glass ionomer cement (RMGIC) (Table 3).

A total of nine studies (43–51) evaluated the presence or absence of secondary caries. Marginal discoloration was reported in six studies (43, 44, 46, 48, 50, 51), marginal adaptation in five (44, 46–49), and marginal or tooth integrity in six (43, 45–47, 50, 51). Additionally, six studies (43, 44, 46–48, 51) evaluated color or translucency, four (43, 46, 47, 50) surface texture or luster, and two (46, 47) surface staining. Retention was reported in five studies (43–47), wear in one (45), and anatomical form in eight (43, 44, 46–51). Three studies (44, 46, 47) evaluated sensitivity, three (45–47) periodontal tissue conditions, three (45–47) contact point integrity, and one (45) occlusion (Table 3).

3.3 Risk of bias analysis of studies

All studies had a low risk of bias (Figure 2).

Figure 2

Figure 2. Risk of bias analysis of included studies.

3.4 Synthesis of results (meta-analysis)

The clinical effectiveness of IRR in comparison to CR in terms of absence of secondary caries, absence of marginal discoloration, adequate marginal adaptation, adequate marginal or tooth integrity, adequate color or translucency, proper surface texture or luster, proper surface staining, retention, proper anatomic form, absence of sensibility, adequate periodontal tissue and integrity of contact point was determined in nine (43–51), six (43, 44, 46, 48, 50, 51), five (44, 46–49), six (43, 45–47, 50, 51), six (43, 44, 46–48, 51), four (43, 46, 47, 50), two (46, 47), five (43–47), eight (43, 44, 46–51), three (44, 46, 47), three (45–47) and three (45–47) studies; which show that there was no statistically significant difference for all these clinical parameters (Supplementary Appendix A, Figures A1 – A12).

Across all meta-analyses, ion-releasing restorations (IRR) demonstrated comparable clinical outcomes to composite resins (CR). No statistically significant differences were found for the evaluated parameters (p > 0.05). Representative pooled effect sizes included: absence of secondary caries (RR = 1.01.95%CI0.99–1.03, p = 0.42); marginal discoloration (RR = 1.00.95%CI0.93–1.08, p = 0.97); marginal adaptation (RR = 1.02.95%CI0.96–1.08, p = 0.48); and retention (RR = 1.02,95%CI0.98–1.07, p = 0.32). These consistent risk ratios close to 1.0 indicate a clinical equivalence between IRR and CR across short- and medium-term follow-up periods. The complete set of estimates is shown in Table 4 and detailed forest plots are available in supplementary Appendix A.

Table 4

Table 4. GRADE analysis of included studies.

3.5 GRADE analysis

When evaluating the included studies, it was observed that there is high certainty in the absence of secondary caries, adequate marginal adaptation, adequate marginal or tooth integrity, proper surface texture or luster, retention, proper anatomic form, absence of sensibility and integrity of contact point; there is moderate certainty in the absence of marginal discoloration, adequate color or translucency and proper surface staining; and the is low certainty in the adequate periodontal tissue (Table 4). The GRADE summary confirmed that none of the clinical outcomes showed statistically significant differences between IRR and CR (all p > 0.05), supporting the equivalence observed in the pooled effect sizes.

3.6 Sensitivity and publication bias analysis

Sensitivity analyzes were conducted by sequentially omitting each included study (leave-one-out analysis) and re-running the meta-analyses. The pooled effect sizes remained stable across all primary outcomes, confirming the robustness of the findings.

Publication bias was evaluated using funnel plots and Egger's regression test (Supplementary Appendix A, Figures A1–A12). No statistically significant bias was detected in any of the assessed outcomes (all p-values ​​>0.05), indicating that small-study effects are unlikely to have influenced the results. Mild asymmetry was visually observed for color/translucency, surface staining, and post-operative sensitivity; However, the corresponding Egger's tests remained non-significant.

4 Discussion

Nine RCTs, mostly conducted in Europe, were included in this meta-analysis. These studies used FDI and modified USPHS criteria to evaluate 12 clinical parameters, and all had a low risk of bias, reinforcing the validity of our findings. No statistically significant differences were found between IRR and CR restorations in any clinical outcome, indicating comparable efficacy. These results align with previous meta-analyses that reported no significant differences between the two materials (6).

The GRADE assessment showed high certainty for 8 outcomes, moderate for 3, and low for 1 (periodontal tissue status), supporting strong confidence in the main findings. These results are in line with recent studies in pediatric restorative dentistry. For instance, Dermata et al. (45) and a 2024 Egyptian RCT (52) reported no differences in failure rate or clinical performance between RMGIC and CR over 2–3 years.

Other reviews also confirmed this equivalence. Krishnakumar et al. reported satisfactory performance of HVGIC, and Albelasy et al. found no significant differences in secondary caries or marginal adaptation between IRR and CR (6, 53). Similar conclusions were reached for color, adaptation, and anatomical shape (53, 54).

Although some studies, such as Dias et al. (54), suggest isolated benefits of IRR in reducing secondary caries, our meta-analysis did not detect such differences—likely due to variations in study populations or follow-up periods. Overall, most recent evidence agrees on the clinical similarity of both materials in terms of retention, staining, and marginal adaptation.

Several factors may explain the observed equivalence. Strict protocols for isolation and technique in the included RCTs likely minimized marginal leakage in both groups. As Albelasy et al. (6) noted, secondary caries development depends on a multifactorial context—oral hygiene, diet, caries risk—beyond just the material. Thus, in well-controlled pediatric settings, the added benefits of ion release may not yield measurable differences.

Additionally, the performance gap between materials may have narrowed due to recent improvements in adhesive systems and “bioactive” CRs with fluoride or antimicrobial agents. This could explain the modest, non-significant differences in color or gloss (moderate certainty).

Sample sizes and follow-up durations (mostly 1–3 years) may have limited the detection of small differences. However, the GRADE analysis provides high certainty in the absence of meaningful disparities, indicating future research is unlikely to change these conclusions.

Furthermore, replacing part of the resin matrix with ion-releasing components in newer materials may balance performance features. For example, Bodur et al. (55) reported no clear superiority among four IRRs, although Fuji II LC showed a slight advantage in retention.

Sensitivity analysis confirmed that no individual study unduly influenced pooled results. Egger's tests for outcomes A1–A12 showed no evidence of publication bias (Supplementary Appendix A, Figures A1–A12), increasing confidence in the findings. Although some funnel plots showed visual asymmetry, small-study effects were not statistically supported.

In summary, this meta-analysis provides robust evidence for the equivalence of IRR and CR in pediatric restorations. Certainty was high for most functional and mechanical outcomes (secondary caries, marginal adaptation and integrity, retention, anatomical shape, sensitivity, contact point). Moderate certainty for color-related parameters suggests possible context-dependent differences. Periodontal health changes should be interpreted with caution due to low certainty.

The overall homogeneity of the results and low risk of bias across studies support evidence-based clinical decisions. Therefore, the selection between IRR and CR can be guided by practical considerations—cost, technical sensitivity, operator preference—without compromising clinical effectiveness.

4.1 Limitations

This study has several limitations that should be acknowledged. First, despite including only randomized clinical trials (RCTs), the heterogeneity in methodologies, sample sizes, and outcome assessment tools across the studies reduces the comparability and generalizability of the results. Second, the moderate to high risk of bias in several domains of the included trials may influence the reliability of the pooled estimates. Third, the follow-up periods varied significantly, and long-term outcomes were not consistently reported, limiting our ability to draw conclusions about durability. Lastly, publication bias could not be entirely ruled out due to the small number of studies per outcome.

5 Conclusions

The results of the present review indicate that there are no significant differences when restoring children's teeth using CR or IRR. According to the GRADE assessment, the certainty of evidence was high for key clinical parameters such as secondary caries, retention, marginal adaptation and integrity, anatomical shape, sensitivity, and contact point. This supports strong confidence in the equivalence of both materials in these outcomes.

However, moderate certainty was found for aesthetic parameters like color, gloss, and surface staining, suggesting that minor differences might be observed in certain contexts. Low certainty was observed for periodontal tissue outcomes, indicating that further research is needed in this area.

Notably, some outcomes exhibited considerable heterogeneity between studies, particularly those related to esthetic and periodontal parameters, which may reflect differences in assessment criteria, follow-up duration, or operator technique.

While the overall findings suggest that both materials are clinically comparable for most restorative purposes in pediatric dentistry, recommendations should be made considering the varying strength of evidence across outcomes, along with clinical context and individual patient needs.

Data availability statement

The original contributions presented in the study are included in the article/Supplementary Material, further inquiries can be directed to the corresponding author.

Author contributions

HA-V: Conceptualization, Formal analysis, Methodology, Supervision, Writing – original draft, Writing – review & editing. FC-O: Investigation, Methodology, Writing – original draft. HV-R: Project administration, Validation, Writing – original draft. FC-Z: Resources, Validation, Visualization, Writing – review & editing. LA-L: Funding acquisition, Validation, Writing – original draft. LA-J: Validation, Writing – original draft. SZ-C: Data curation, Writing – original draft.

Funding

The author(s) declare that no financial support was received for the research and/or publication of this article.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Generative AI statement

The author(s) declare that no Generative AI was used in the creation of this manuscript.

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Publisher's note

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Supplementary material

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fdmed.2025.1651696/full#supplementary-material

The meta-analyses of the data extracted from the included studies is presented. The data involved the following 12 clinical parameters: absence of secondary caries, absence of marginal discoloration, adequate marginal adaptation, adequate marginal or tooth integrity, adequate color or translucency, proper surface texture or luster, proper surface staining, retention, proper anatomic form, absence of sensibility, adequate periodontal tissue and integrity of contact point. The results are presented as forest plots; where: CR, composite resin; IRR, Ion-releasing restorative; CI, confidence interval; df,  degrees of freedom; M-H, Mantel-Haenszel; I²,Higgins I² test; Chi², Chi square test. Additionally, funnel plots and results of Egger's tests are included to assess publication bias. A leave-one-out sensitivity analysis under random-effects DerSimonian-Laird model is also presented, evaluating the influence of each individual study on overall effect estimate.

All Egger's test p-values are reported below each funnel plot (Supplementary Figures A1–A12), and the p-values for each excluded study are shown in the final column of the sensitivity analyses.

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