An interventional study of Low Shrinkage Giomer in Caries, Cervical, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Management of cervical lesions presents serious problems with any restorative material. The two most common reasons for restoration failure are secondary caries at the tooth-restoration interface and loss of retention. Class V lesions often exhibit a low retentive cavity configuration (C-factor); which is responsible for marginal gaps around the restorations. Cervical margins -lying in either dentin or cementum- show unfavorable bonding performance, besides being usually subgingival where moisture control is difficult. The subgingival margin is not clinically desirable due to difficulty in cleaning and increased biofilm accumulation. Therefore, the selection of the restorative material can be challenging.
Resin composites are known for their high mechanical properties, excellent esthetic properties, and ease of clinical application. However, when compared with glass ionomers, resin composite has no cariostatic effect on tooth structure. In addition, microleakage caused by polymerization shrinkage of resin composite leads to plaque accumulation and secondary caries. On the other hand, resin-modified glass ionomer has many advantages, yet still it has lower weakness and esthetic properties compared to resin composite.
Based on current literature, there is limited evidence comparing clinical performance of low-shrinkage giomer resin composite to resin-modified glass ionomer in the treatment of cervical caries lesions.
This study is conducted to evaluate the clinical performance of low-shrinkage giomer resin composite versus resin-modified glass ionomer in treatment of cervical caries lesions, using both Modified USPHS and Revised FDI criteria. This study will be designed to test the null hypothesis that the low-shrinkage giomer resin composite will have the same clinical performance as resin-modified glass ionomer in cervical restorations, using both Modified USPHS and Revised FDI criteria.
The development of cervical lesions in permanent dentition may be related to carious or non- carious origin. Class V caries lesions may occur due to different factors such as poor oral hygiene, dietary habits, or xerostomia.
Management of cervical lesions presents serious problems with any restorative material. The two most common reasons for restoration failure are secondary caries at the tooth-restoration interface and loss of retention. Class V lesions often exhibit a low retentive cavity configuration (C-factor); which is responsible for marginal gaps around the restorations. Cervical margins -lying in either dentin or cementum- show unfavorable bonding performance, besides being usually subgingival where moisture control is difficult. The subgingival margin is not clinically desirable due to difficulty in cleaning and increased biofilm accumulation. Therefore, the selection of the restorative material can be challenging.
In this context, fluoride containing adhesive materials are considered ideal in restoring class V carious lesions. Resin modified glass ionomers (RMGI) are highly recommended in the restoration of cervical lesions. The most important advantages of glass ionomer are its chemical adhesion to the tooth structure, and its fluoride release. However, RMGI has lower weakness and esthetic properties compared to resin composite.
In our study, the comparator material will be light cured resin reinforced glass ionomer restorative. RMGI is recommended to restore carious cervical lesions; especially with its ability to inhibit secondary caries due to its fluoride releasing ability. The main advantage of RMGI is its capability to chemically bond to tooth structure, even in the presence of moist dentin. RMGI reaction can be achieved by both acid-base reaction (induced by glass ionomer component) and polymerization reaction (induced by resin component). Thus, RMGI has better mechanical properties, wear resistance, and improved esthetics compared with conventional glass ionomer. In addition, the coefficient of thermal expansion of glass ionomer which is similar to that of tooth structure, allows for proper marginal adaptation without marginal leakage.
Resin composites have been widely used in dental practice; because of their high mechanical properties, excellent esthetic properties, and ease of clinical application.
However, when compared with glass ionomers, resin composite has no cariostatic effect on tooth structure. In addition, polymerization shrinkage of resin composite is of major concern; where mechanical stresses are developed due to contraction leading to break the marginal seal between resin composite and tooth structure. Polymerization shrinkage can cause clinical issues as restoration or tooth fracture, bond degradation and solubility, and microleakage. The microleakage caused by polymerization shrinkage of resin composite leads to plaque accumulation and secondary caries. Thus, choosing a fluoride-releasing and low-shrinkage resin composite may play a critical role in success of cervical restorations.
The continued development of resin composites has led to the introduction of Giomer technology. By combining the characteristics of resin composite and glass ionomer, hybrid products called giomers have been obtained. Giomer resin composite offers protection against caries, along with improved functional and esthetic properties; through incorporating particles of pre-reacted glass fillers (PRG) into the matrix of resin composite. The PRG-ionomer phase has the capability to release six key ions which are fluoride, aluminum, borate, silicate, strontium, and sodium ions. These ions exhibit acid neutralizing ability and help prevent demineralization of enamel and dentin, leading to decrease the possible incidence of secondary caries. This PRG technology provides giomer with both fluoride release and recharge, similar to glass ionomer while still maintaining the original physical properties of resin composite.
Beautifil™ II LS (Low shrinkage) giomer resin composite (Shofu Inc, Kyoto, Japan) shows both sustained fluoride release and recharge, and low volumetric shrinkage of less than 1% with low resultant polymerization shrinkage stress. Such remarkable feature is due to the novel SRS (Steric Repulsion Structured) molecule which is designed to decrease polymerization shrinkage through molecular steric repulsion resulting in a stable restoration microstructure. Thus, low shrinkage giomers are best indicated in class V cavities where the dentin bonding agent does not have high strength.
A recent clinical trial compared the clinical performance of giomers versus resin modified glass ionomer in proximal lesions. Marginal adaptation was higher in giomers than resin-modified glass ionomers after 12 months. Also, a systematic review investigated in vivo longevity of giomers compared to other adhesive restorative materials (hybrid resin composite, composmer, and RMGIC), and concluded that RMGIC was the most successful material in terms of biological properties while giomers had the longest survival rate. An in-vitro study evaluated the surface roughness and fluoride release of Beautifil II and Fuji II LC (resin-modified glass ionomer). Resin-modified glass ionomer showed the highest fluoride release, while the giomer showed an intact, smooth surface with no irregularities as those found in glass ionomer. Thus, the smooth surface of giomers inhibit biofilm formation, decreasing the risk of dental caries and periodontal diseases. Regarding the mechanical properties of giomers, it has exhibited a higher flexural strength value when compared to glass ionomer cements. The hardness values were twice as high for the giomer when compared to self-curing and light-curing glass ionomer cements.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's enrollment of 56 is close to the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
RMGI is recommended to restore carious cervical lesions; especially with its ability to inhibit secondary caries due to its fluoride releasing ability. The main advantage of RMGI is its capability to chemically bond to tooth structure, even in the presence of moist dentin. RMGI reaction can be achieved by both acid-base reaction (induced by glass ionomer component) and polymerization reaction (induced by resin component). Thus, RMGI has better mechanical properties, wear resistance, and improved esthetics compared with conventional glass ionomer (AlQranei MS et al, 2021). In addition, the coefficient of thermal expansion of glass ionomer which is similar to that of tooth structure, allows for proper marginal adaptation without marginal leakage (Bollu IP et al, 2016).
Other: Low Shrinkage Giomer
Low shrinkage giomer resin composite shows both sustained fluoride release and recharge, and low volumetric shrinkage of less than 1% with low resultant polymerization shrinkage stress. Such remarkable feature is due to the novel SRS (Steric Repulsion Structured) molecule which is designed to decrease polymerization shrinkage through molecular steric repulsion resulting in a stable restoration microstructure (AlQranei MS et al, 2021). Thus, low shrinkage giomers are best indicated in class V cavities where the dentin bonding agent does not have high strength (Algailani U, et al 2022).
Other: Low Shrinkage Giomer
Low shrinkage giomer resin composite shows both sustained fluoride release and recharge, and low volumetric shrinkage of less than 1% with low resultant polymerization shrinkage stress. Such remarkable feature is due to the novel SRS (Steric Repulsion Structured) molecule which is designed to decrease polymerization shrinkage through molecular steric repulsion resulting in a stable restoration microstructure (AlQranei MS et al, 2021). Thus, low shrinkage giomers are best indicated in class V cavities where the dentin bonding agent does not have high strength (Algailani U, et al 2022).
Clinical performance
fracture and retention, marginal adaptation, form and contour, caries at the restoration margins, dental hard tissue defects, and postoperative hypersensitivity, surface luster and surface texture, marginal staining, and color match All these outcomes are measured using revised FDI criteria for clinical evaluation of restoration; where they will be given a score either excellent (1), good (2), satisfactory (3), unsatisfactory (4), or poor (5) - (acceptable = score 1 to 3, inacceptable but repair possible = score 4, and inacceptable but repair not possible/reasonable = score 5).
Time frame: 12 months: change from baseline to six, and 12 months.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2023 to primary completion in Nov 2024, 14 months.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's 14 months is below that.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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