Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements: A Randomized Controlled Trial

doi:10.21203/rs.3.rs-4953935/v1

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Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements: A Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-4953935/v1

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Aims

To evaluate the clinical success, impact on periodontal health, and parental satisfaction of pediatric fiberglass crowns (FGCs) applied to primary molars using two different luting cements.

Methods and Materials

In this study, 60 FGCs were applied to the primary molars of 38 children aged five-nine years, using two different cement materials [glass-ionomer cement (GIC) and resin-modified GIC (RMGIC)]. During the 12-month control period, the retention, anatomical integrity, effect on periodontal health and parental satisfaction of FGCs were evaluated. The plaque index (PI) and gingival index (GI) scores of all teeth, including those treated with crowns (FGC group) and their symmetrical, healthy counterparts (control group), were evaluated both before and after the application of FGCs.

Results

Although the highest survival was observed in the group cemented with RMGIC, there was no significant difference between the groups (p > 0.05). There was no statistically significant change in the periodontal index scores of the FGC group compared with the initial values (p > 0.05). There was a significant decrease in the periodontal index scores of the overall and control groups compared with the initial values (p < 0,05). When the gingival index scores were evaluated, the increase observed in the control sessions compared with the initial values is significantly greater (p ≤ 0.001).

Conclusion

At the end of the 12-month follow-up period, although the survival rate was higher in the RMGIC group, the clinical success rate of FGCs was low in general. It can be suggested that FGCs could serve as an aesthetic alternative for primary tooth crown restorations; however, improvements in their mechanical and surface properties are needed.

Trial Registration

The study was retrospectively registered on www.clinicaltrials.gov with registration number (NCT06558734).

Fiberglass crown

Luting cement

Glass-ionomer cement

Resin-modified glass-ionomer cement

Periodontal index

Primary teeth

Caries lesions, which are commonly observed in primary teeth, significantly impact children's overall health status, quality of life, aesthetic appearance, and psychological development due to associated confidence issues [1]. Moreover, cavities occurring in primary teeth progress rapidly because of structural differences compared with permanent teeth, leading to swift and extensive decay [2]. Coronal crown restorations are preferred for extending the longevity of teeth with extensive caries in primary molars or those with developmental anomalies. Pediatric crowns consisting of different materials are preferred for the restorations of primary teeth [3]. Stainless steel crowns (SSCs) are the first type of coronal restoration developed for this purpose. While recognized for their durability, these crowns enable long-lasting treatments but are deficient in aesthetic appeal [4]. Recently, pediatric zirconium crowns (PZCs) have been produced for the aesthetic restoration of primary teeth using zirconium material, because of their superior aesthetic and mechanical properties. Compared with other crowns used for primary teeth in pediatric dentistry, these crowns present improved aesthetics, biocompatibility, and color stability [5]. However, alongside these benefits, they entail certain drawbacks, including the necessity for relatively extensive preparation and technical precision, inability to make adjustments to the crown, and increased cost [6].

In recent years, pediatric fiberglass crowns (FGCs) have been developed to eliminate the disadvantages of SSCs and PZCs, leveraging the favorable properties inherent in fiber materials [7]. Fiber crowns, known for their biocompatibility and strong mechanical attributes, are considered a potential new alternative for full coronal crown applications in pediatric dentistry [8]. Nevertheless, there appears to be a scarcity of accessible studies concerning the clinical efficacy and parental satisfaction levels of FGCs, and in these studies, the clinical success of FGCs was found to be low [9–11].

The reasons for the failure of crown restorations cannot be attributed solely to the type of crown materials used. Factors such as preparation design, fitting parameters, inadequate crown pretreatment, and the type of cementation are also crucial for clinical success [12–13]. In an in vitro study on the fracture resistance of FGCs, it was determined that the luting cements used effectively affected the outcome. Therefore, the aim of this study was to evaluate the clinical success of FGCs used in the restoration of primary teeth during a 12-month follow-up period and to assess the impact of two different luting cements. Additionally, this study aimed to investigate the effects of FGCs on periodontal health and parental satisfaction.

The null hypotheses in this study were as follows:

H1: There will be no difference between the cementation materials used in terms of their effect on the retention and mechanical performance of FGCs.

H2: Similar results are obtained when the periodontal index scores of teeth with FGC are compared with those of healthy teeth.

H3: Parental satisfaction will be high after the 12-month follow-up.

This was a prospective, randomized, controlled clinical trial. The study protocol was retrospectively registered at www.clinicaltrials.gov with registration number (NCT06558734), following approval by the local ethics committee (approval date/number 18.01.2020/11). The study was designed, analyzed, and interpreted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist [14]. The research adhered to the guidelines outlined in the Declaration of Helsinki, which delineates the ethical principles governing medical research involving human subjects.

Sample size calculation

Because of the limited availability of studies with similar characteristics, the sample size analysis of the study was conducted on the basis of the reported success rates by Mostafa et al., [10] which indicated a 70% success rate for fiber crowns. The analysis was performed using G*Power 3.1 software, with 85% power and a 0.5 effect size selected. The analysis revealed that a minimum of 24 crowns were required in each group. Taking into account the possibility of patient dropout during the 12-month study period, the sample size was increased by 20%, resulting in a decision to aim for a minimum of 30 crowns in each group.

Participant settings and eligibility criteria

This study was conducted on 38 children aged 5–9 years who presented with dental caries at Akdeniz University, Faculty of Dentistry, Department of Pediatric Dentistry. The study protocol involved securing written consent from the parents and verbal assent from the children involved in the research procedure.

Participants who met the following criteria were included in the study: absence of any systemic disease, absence of any periodontal disease, no unilateral chewing habit, a Frankl scale score of three or four [14], and teeth that met the following criteria: no sensitivity to percussion or palpation, no malocclusion, no pathological mobility, no pulpal treatment due to caries or other reasons, sound cervical margins, and deep dentin caries involving two or more surfaces without pulp involvement. However, children with hypoplastic, defective, missing, or restored contralateral teeth, or teeth with any developmental defect and physiological root resorption exceeding one-third of the root length, were excluded.

Grouping

One hundred twenty primary molar teeth were included in the study. Sixty decayed primary molars are divided into two groups according to the luting cement used: the glass-ionomer cement (GIC) (GC FujiOne, Tokyo, Japan) group (n = 30) and the resin-modified glass-ionomer cement (RMGIC) (GC FujiCEM 2, Tokyo, Japan) group (n = 30). The other 60 intact contralateral teeth were evaluated the controls.

Intervention

FGCs (Figaro Crowns Inc., USA) of the most suitable size in terms of the mesio-distal dimension of the tooth were selected. The preparation was performed in a manner to ensure the seating of the FGC onto the tooth specified by the manufacturing company [7]. Following the establishment of anesthesia, the teeth were prepared using diamond cutting burs with a high-speed, water-cooled turbine handpiece. To achieve adequate interocclusal space, an occlusal reduction of 1–2 mm was executed along with a proximal reduction reaching 1 mm below the gingival margin. A more conservative reduction was applied to the buccal and lingual surfaces. After preparation, any remaining decayed dentin tissue was removed using a steel round bur with a low-speed micromotor. To ensure occlusal harmony, diamond burs were used to perform abrasion on the crown edges, and the trimmed crown edges were polished using rubber aids before cementation. Following the establishment of isolation with cotton rolls, the FGCs were cemented following the manufacturer's guidelines (Fig. 1) [15]. In cases where multiple crowns are applied to the same patient, two distinct luting cements are utilized. Postcementation, and occlusal adjustments were performed, and patients received oral hygiene education. All the clinical procedures were performed by a single investigator.

Randomization

To prevent specific adjustments of the material to be used in cementation, randomization was carried out after the preparation. The patients were then asked to choose one of the preprepared cards, each representing a different luting material. Following selection, cementation was performed by a single investigator who performed all the clinical procedures.

Follow-up

Follow-up assessments were performed at 1st, 3rd, 6th, and 12th months posttreatment. Clinical and radiographic evaluations were conducted by a single investigator. Crown success was categorized as "successful" if no loss or fractures occurred and "unsuccessful" otherwise. Failed cases are classified as decementation, occlusal wear, and fracture. Fracture classification includes large loss or chipped cases.

The plaque index (PI) and gingival index (GI) scores of all teeth, including those treated with crowns (FGC group) and their symmetrical, healthy counterparts (control group), were evaluated and recorded both before and after the application of the FGCs. PIs and GIs were evaluated using the criteria established by Silness and Löe [16]. In the evaluation of the periodontal index, plaque control was carried out via a plaque-disclosing agent (Plaque Test, Ivoclar Vivadent, Liechtenstein) (Fig. 2).

Radiographic assessments of FGCs were conducted via periapical radiographs, assessing criteria such as internal-external root resorption, lesions within the furcation area, and widening of the periodontal space.

Using Roberts et al.'s [17] criteria, parental satisfaction was assessed by evaluating appearance, color, shape, size, and durability.

Blinding

During follow-up appointments, the investigator conducting the evaluations was blinded to the group allocation of each crown because the two luting cements being compared could not be visually distinguished. Furthermore, the participants were blinded to the luting cement used since they did not observe the material used during the cementation phase.

Statistical analyses

The collected data were entered into the SPSS software package (SPSS 18.00 for Windows, Chicago, IL, USA) to perform descriptive statistics and comparative tests. For comparing the quantitative data, the parametric conditions were assessed using Levene’s test; if the conditions were met, the Student’s T-test was used. For repeated measurements between groups, one-way analysis of variance (ANOVA) was used, and subgroup comparisons were made using the Tukey HSD multiple comparison test. In cases where parametric conditions were not met, qualitative data and group comparisons were analyzed using the Kruskal-Wallis, Mann-Whitney U, Wilcoxon, and chi-square (χ2) tests. Survival analysis was conducted using the Kaplan-Meier method. The results were interpreted within a 95% confidence interval, and significance was set at p < 0.05.

A flow diagram showing the study protocol up to the 12-month follow-up is presented in Fig. 3. In total, 38 children (24 boys, 14 girls) treated with 60 FGCs, with a mean age of 7.03 ± 1.14 years, met the inclusion criteria for this study.

Evaluation of the clinical success of FGCs applied to primary molars

At the one-month follow-up, all the crowns were recorded as successful. At the third month follow-up, two crowns in the RMGIC group were decemented, and one crown in the GIC group was fractured. At the sixth-month follow-up, an abscess was observed in one tooth from both the GIC and RMGIC groups, and one patient who had one crown from each group did not attend the follow-up visit. Decementation was observed in two crowns, and fracture was noted in three crowns within the GIC group. Additionally, fractures were observed in two crowns within the RMGIC group. At the 12-month follow-up, decementation was observed in two crowns, fracture in three crowns, and occlusal wear in seven crowns belonging to the GIC group. In the RMCIS group, decementation was observed in three crowns, and occlusal wear was observed in five crowns (Fig. 4). Throughout the 12-month follow-up period, the cement remained on the tooth in all of the decemented FGCs. At the end of the study, a total of 26 FGCs were classified as successful, and 30 FGCs were classified as unsuccessful (9 fractures, 9 cases of decementation, and 12 cases of wear) (Table 1) (Fig. 5). When the results were evaluated, that there was no statistically significant difference according to sex, tooth number or cementation material used. (p > 0.05).

Table 1. Clinical evaluation of GFCs according to tooth type, success, and luting cement

Evaluation of the Plaque Index and Gingival Index Scores

The study revealed no statistically significant differences in the PI and GI scores between genders and cementation materials, both initially and during the follow-up periods (p > 0,05).

When the general PI scores were evaluated, there was a decrease compared with the initial values at the first-month follow-up, and the difference was statistically significant (P = 0,001). At subsequent follow-up appointments, the change was not significant (p > 0,05) (Table 2).

There was no statistically significant difference in the PI scores of the FGC group compared with the initial values (p > 0,05). Upon evaluating the GI scores of the FGC group, a statistically significant increase was observed in the control sessions compared with the initial values (P ≤ 0,001) (Table 2).

The PI scores of the control group decreased compared with the initial values, except for the sixth-month controls, and this change was statistically significant (p < 0,05). The GI scores of the control group increased compared with the initial values, except for those of the third-month controls. However, the increase in GI scores compared with the baseline values was not significant, except for the sixth month controls (p > 0,05) (Table 2).

When the overall PI scores of the patients were compared with the PI scores of the FGC group, the overall PI scores were lower at the follow-up appointments, but the difference was not statistically significant (p > 0,05).

When the overall PI scores of the patients were compared with the PI scores of the control teeth, no statistically significant difference was observed (p > 0.05).

When the PI scores of the FGC group and control group were compared, there was no significant difference at the first month of follow-up (p > 0.05). However, in subsequent assessments, the PI scores of the control group significantly decreased (p < 0,05).

When the GI scores of the FGC group were compared with those of the control group, the GI scores of the FGC group were significantly higher in all the control sessions (p ≤ 0.001).

Evaluation of parental satisfaction

Analysis of parental evaluations, scored from one to five, indicated general satisfaction with the FGCs (averaging four). However, the satisfaction with durability was lower than that with the other parameters. The gender of the children treated with FGCs did not significantly affect parental satisfaction (p > 0,05).

In this study, retention, clinical success, impact on periodontal health, and parental satisfaction of primary molars with excessive material loss treated with FGCs using two different luting cements were evaluated. FGCs, introduced as a new alternative to tooth-colored crowns commonly used in pediatric dentistry, have been developed on the basis of the favorable physical properties of fibers. At the end of the 12-month follow-up period, the null hypothesis was partially accepted; no significant difference was found between the cementation materials used in terms of their effect on the retention and mechanical performance of the GFCs. The periodontal index scores of teeth with GFC were found to be high compared with those of healthy teeth, and parental satisfaction with aesthetic parameters was satisfactory, but satisfaction with durability was lower.

Although the manufacturer indicates that FGCs can be cemented with any glass ionomer-based cementation material [15], different results can be obtained with different brands and forms of materials. El-Habashy and El Meligy [9] reported no cases of decementation in FGCs cemented with GIC after six months. In similar studies where Mostafa et al. [10] and Talekar et al. [11] used GIC as the cementation material, they reported decementation rates of 15% and 9%, respectively. In this study, in cases where crowns failed due to decementation, the cement material remained on the tooth surface, indicating that the reasons for failure were attributed to the bonding between the crown and the cement materials. Pereira et al. [18] reported in their in vitro study that fiber materials cemented with GIC exhibited higher bond stregths than those cemented with RMGIC. In contrast to these findings, Li et al. [19] and Cheruvathoor et al. [20] reported in their studies evaluating the effect of luting cement on the retention of fiber materials that RMGICs yielded more successful outcomes. In this study, decementation cases were observed in 13% of the GIC group and 17% of the RMGIC group, with no significant difference detected between the cementation materials.

FGCs were initially introduced to the market with promising results from the manufacturing company, claiming superior fracture resistance compared with other pediatric crown materials because of their good mechanical properties and flexible structure. [7] In their in vitro study comparing FGCs and PZCs, Çiftçi et al. [8] noted that FGCs exhibited higher fracture resistance than PZCs did. However, different outcomes have been in clinical reported studies. In this study, after a six-month period, five (8%) fractures were detected in FGCs. In other in vivo studies, lower success rates have been reported. El-Habashy and El Meligy [9] reported a total of six (38%) chipped and eight (50%) large loss cases at the six-month follow-up. Similarly, Mostafa et al. [10] noted a total of four (20%) chipped and four (20%) large loss cases at the six-month follow-up. In their in vivo study, Talekar et al. [11] reported seven (21%) cases of chipped/partial loss at the end of a 12-month period. In the 12th month of our study, a total of nine (15%) cases of fracture were observed. The results of in vivo studies and in vitro studies differ, particularly with respect to the mechanical properties of the material. The reason for these different results lies in the numerous limitations of in vitro studies to mimic the oral environment. It has also been reported that the clinical period during which the crown functions in the oral cavity causes material fatigue, and fiber-reinforced materials may experience a decrease in their mechanical properties over time because of exposure to the moist oral environment [21, 22].

The materials used in cementation not only affect bonding but also affect the mechanical properties of crown materials. In a study evaluating the effects of four different cementation materials on the fracture resistance of PZCs, the highest success rate was observed in crowns cemented with RMGIC [15]. In another study, luting cements affected the fracture resistance of PZCs and FGCs [8]. Similarly, this study revealed that crowns cemented with GIC resulted in fractures in 7 crowns (24%), whereas those cemented with RMGIC resulted in fractures in only 2 crowns (6%). In previous studies, GIC was used as the luting cement, and the results were similar to those of our GIC group. However, the group cemented with RMGIC present a lower incidence of fractures, suggesting that the type of luting cement may influence the fracture resistance of the crowns.

Several studies have indicated that fiberglass crowns exhibit low wear resistance. An in vitro study comparing the wear resistance of SSCs and FGCs revealed that FGCs demonstrated significantly higher occlusal wear [24]. A clinical study reported a 47% incidence of occlusal wear in FGCs after a 12-month follow-up period [11]. In this study, no instances of wear were observed during the initial 6 months; however, by the 12th month, occlusal wear was noted in a total of 12 crowns.

The accumulation of plaque on the surface of restorative materials is closely associated with the long-term success of restorations and the health of periodontal tissues [16]. When studies are examined, different outcomes are obtained depending on the crown materials [9, 26]. In this study, a decrease in periodontal index scores was observed in the patients' overall and control teeth. There was no change in the PI score in the FGC group, but there was a statistically significant increase in the GI score. This finding supports the results of a few other studies. In teeth treated with FGCs and PZCs by Talekar et al.^[11] at the 18th month, only 6% of PZCs presented minimal plaque retention, whereas 39% of FGCs presented minimal and 32% severe plaque retention. These studies indicate that the surface characteristics of FGCs may lead to increased plaque accumulation. Notably in a moist oral environment, fiber-reinforced materials may lose their stability over time and cause irritation when fibers protrude from the matrix [21]. The increase in the GI score in this study may have occurred because of this situation. However, in a study comparing the PI scores of FGCs and SSCs, there was no statistically significant difference between crown types [9].

The favorability of restoration to both children and parents is as crucial as its possession of ideal characteristics. Various studies have reported that parents play a significant role in the selection of dental restorations for children and that parents also prefer aesthetic materials in terms of tooth color [19, 20]. In a clinical study aiming to compare the clinical success of FGCs and SSCs, it was reported that all parents preferred FGCs during the initial visit and the three-month follow-up appointment; however, there was a significant decrease in preference for FGCs at the six-month follow-up. This decline was attributed to the structural deterioration observed in FGCs [9]. Another study comparing the clinical success of FGCs and PZCs also evaluated parental satisfaction, and reported that at the 18-month follow-up, the percentage of parents who were completely dissatisfied with the crowns was 32% in the FGC group and 6% in the PZC group [11]. In this study, the results obtained from the questionnaire administered to the parents of patients, when evaluating aesthetic parameters, were satisfactory. However, at the end of the 12th month, satisfaction with durability was lower.

One of the limitations of our study is the lack of a split-mouth design. Although crowns are cemented with two different materials in most patients, in some cases, only a single crown was used. This situation hinders the standardization of factors that could influence outcomes, such as chewing force, chewing habits, and oral hygiene practices. Furthermore, despite efforts to standardize the amount of preparation, variations in its execution, differences in the size of existing carious lesions, and the application of different sized crowns to different tooth types constitute additional limitations of our study.

At the end of the 12-month follow-up period, although there was no statistically significant difference in the fracture resistance of FGCs according to the luting cement used, a lower rate of fracture was observed in the RMGIC group. To support this finding, studies with larger sample sizes are needed. The clinical success of FGCs was lower than expected, and the periodontal index scores were high. These results suggest that FGCs could serve as an aesthetic alternative for primary tooth crown restorations; however, improvements in their mechanical and surface properties are needed.

FGC Fiberglass Crown

GIC Glass-ionomer cement

RMGIC Resin-modified glass-ionomer cement

PI Plaque index

GI Gingival index

SSC Stainless steel crowns

PZC Pediatric zirconium crowns

Acknowledgements

Not applicable.

Author contributions

K.B. and Z.Z.C. formulated the present hypothesis and designed the study. K.B. performed clinical procedures. B.B.K. acquired the data. H.K. conducted the statistical analysis. K..B., Z.Z.C. and B.B.K. wrote the main manuscript text. H.K. provided critical revisions and contributed to the discussion section. All authors reviewed and approved the final manuscript.

Funding

This study was supported by the Scientific Research Projects Coordination Unit of Akdeniz University, Antalya, Turkey (Project ID: TDH-2019-4874).

Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Ethics approval and consent to participate

The Clinical Research Ethics Committee of Akdeniz University Faculty of Medicine (approval date/number 18.01.2020/11). All participants provided informed consent to participate in the study.

Consent for publication

Not applicable.

Competing interests

Authors have no conflict of interest to declare.

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No competing interests reported.

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Evaluation of the Clinical Success of Pediatric Fiberglass Crowns in Primary Teeth Using Different Luting Cements: A Randomized Controlled Trial

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Abstract

Figures

Introduction

Materials and Methods

Sample size calculation

Participant settings and eligibility criteria

Grouping

Intervention

Randomization

Follow-up

Blinding

Statistical analyses

Results

Evaluation of the clinical success of FGCs applied to primary molars

Evaluation of parental satisfaction

Discussion

Conclusion

Abbreviations

Declarations

References

Additional Declarations

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