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Evaluation of Giomer Composite Versus Resin-Modified Glass Ionomer in Cervical Caries Lesions: A Clinical Trial

Primary Purpose

Caries, Cervical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Shrinkage Giomer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Cervical

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Patients with carious cervical lesions (1-2 mm axial depth) in maxillary anterior teeth. Patients with at least 20 teeth under occlusion. Age: 16-55 years. Males or females Asymptomatic vital teeth. Co-operative patients approving to participate in the trial. Exclusion Criteria: Patients younger than 16 years old or older than 55 years old. Extensive cervical lesions extending beyond proximal line angles. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Teeth supporting removable prostheses, or orthodontic appliances. Candidates with parafunction or bruxism. Candidates with systemic diseases or disabilities that may affect participation. Drug-induced xerostomia. Known allergy to resin-based composites or RMGIs. Heavy smoking. Pregnancy. Lack of compliance.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Resin modified glass ionomer

    Low shrinkage giomer

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Clinical performance
    Retention, color match, marginal discoloration, secondary caries, wear, and post-operative sensitivity. All these outcomes are measured using modified USPHS criteria for clinical evaluation of restoration failure; where they will be given a score: Alpha is excellent, Bravo is acceptable, Charlie is not accepted.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 23, 2023
    Last Updated
    June 30, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05930548
    Brief Title
    Evaluation of Giomer Composite Versus Resin-Modified Glass Ionomer in Cervical Caries Lesions: A Clinical Trial
    Official Title
    Clinical Evaluation of Low-shrinkage Giomer Resin Composite Versus Resin-Modified Glass Ionomer in Treatment of Cervical Caries Lesions: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    April 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caries, Cervical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Resin modified glass ionomer
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Low shrinkage giomer
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Low Shrinkage Giomer
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Clinical performance
    Description
    Retention, color match, marginal discoloration, secondary caries, wear, and post-operative sensitivity. All these outcomes are measured using modified USPHS criteria for clinical evaluation of restoration failure; where they will be given a score: Alpha is excellent, Bravo is acceptable, Charlie is not accepted.
    Time Frame
    18 months: change from baseline to six, 12, and 18 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Patients with carious cervical lesions (1-2 mm axial depth) in maxillary anterior teeth. Patients with at least 20 teeth under occlusion. Age: 16-55 years. Males or females Asymptomatic vital teeth. Co-operative patients approving to participate in the trial. Exclusion Criteria: Patients younger than 16 years old or older than 55 years old. Extensive cervical lesions extending beyond proximal line angles. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Teeth supporting removable prostheses, or orthodontic appliances. Candidates with parafunction or bruxism. Candidates with systemic diseases or disabilities that may affect participation. Drug-induced xerostomia. Known allergy to resin-based composites or RMGIs. Heavy smoking. Pregnancy. Lack of compliance.

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Giomer Composite Versus Resin-Modified Glass Ionomer in Cervical Caries Lesions: A Clinical Trial

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