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

NCT05930548 | Completed

• 1 other identifier: LSG_RMGI
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries, Cervical

Keywords

Cervical carious lesions; Low shrinkage giomer resin composite; Resin modified glass ionomer; FDI criteria

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months: change from baseline to six, and 12 months.

Study Arms (2)

Resin modified glass ionomer

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

Low Shrinkage Giomer OTHER

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).

Low shrinkage giomer; Resin modified glass ionomer

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with carious cervical lesions in maxillary anterior teeth. Patients with at least 20 teeth under occlusion.
• Age: 25-50 years.
• Males or females
• Asymptomatic vital teeth. No pulp pathology or periapical pathosis
• Healthy periodontium and favorable occlusion.
• Good general health
• Co-operative patients approving to participate in the trial.

You may not qualify if:

• Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
• Parafunctional habits or TMJ disorders
• Active periodontitis
• Teeth supporting removable prostheses, or orthodontic appliances.
• Candidates with parafunction or bruxism.
• Candidates with systemic diseases or disabilities that may affect participation.
• Xerostomia.
• Heavy smoking.
• Pregnancy.
• Lack of compliance.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Giza, Egypt

Location

Related Publications (1)

• El Ghamrawy M, Kamal D, Hamza H. Clinical performance and cost-effectiveness of low-shrinkage giomer resin composite versus resin-modified glass ionomer in cervical carious lesions: a 12-month randomized controlled trial. BMC Oral Health. 2025 Aug 6;25(1):1295. doi: 10.1186/s12903-025-06594-y.

  PMID: 40770630 DERIVED

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 5, 2023
• Study Start: September 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

EG (1)