Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months.

NCT ID: NCT05389163

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-17
• Study Completion Date: 2024-07-04

Brief Summary

Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.

Detailed Description

In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. Their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.

Conditions

Class V Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Giomer based injectable resin composite

Beautifil Flow plus X F03, SHOFU, USA

Group Type: EXPERIMENTAL

Giomer based injectable resin composite

Intervention Type: DEVICE

Giomer material has been introduced as the true hybridization of glass ionomer and resin composite, containing surface pre-reacted glass ionomer (S-PRG) filler particles within a resin matrix. Giomer combines caries protection through fluoride release and recharge of glass ionomers and the esthetics, physical and handling properties of resin composite

Resin modified glass ionomer

Fuji II LC, GC

Group Type: ACTIVE_COMPARATOR

Resin modified glass ionomer

Intervention Type: DEVICE

Resin modified glass ionomer (RMGI) have been developed to combine the advantages of both resin composite and glass ionomer; the good mechanical properties, esthetic of resin composite added to anticariogenic activity and chemical bonding to tooth structure of glass Ionomer.

Interventions

Giomer based injectable resin composite

Giomer material has been introduced as the true hybridization of glass ionomer and resin composite, containing surface pre-reacted glass ionomer (S-PRG) filler particles within a resin matrix. Giomer combines caries protection through fluoride release and recharge of glass ionomers and the esthetics, physical and handling properties of resin composite

Intervention Type: DEVICE

Resin modified glass ionomer

Resin modified glass ionomer (RMGI) have been developed to combine the advantages of both resin composite and glass ionomer; the good mechanical properties, esthetic of resin composite added to anticariogenic activity and chemical bonding to tooth structure of glass Ionomer.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18-60 years.
• Co-operative patients approving to participate in the study.
• Male or female patients.
• Patients with good general health
• Moderate or high caries risk patient

• Cervical Class V carious lesions.
• Pulp asymptomatic vital carious teeth.

Exclusion Criteria

• Systemic disease or severe medical complications.
• Participants with a history of allergy to any component of restorations will be used in the study.
• Lack of compliance
• Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

• Presence of apical or periapical pathosis.
• tooth mobility
• Non-vital teeth.
• Teeth with advanced periodontal diseases.
• Teeth which need indirect restoration.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reham Adel Yahia Hendam

assistant lecturer at conservative department,,faculty of dentistry, modern university for Technology and Information.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Giomer vs RMGI in class V

Identifier Type: -

Identifier Source: org_study_id