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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Class V Dental Caries
• Intervention / Treatment: Device: Giomer based injectable resin composite; Device: Resin modified glass ionomer

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham Adel Hendam, Master degree; Phone Number: 02 01224784965; Email: reham.hendam@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Participant 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

Teeth Inclusion Criteria

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

Participant 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

Teeth Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Giomer based injectable resin composite; Beautifil Flow plus X F03, SHOFU, USA	Device: 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
Active Comparator: Resin modified glass ionomer; Fuji II LC, GC	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance (Marginal adaptation)	Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %. Alpha is the best outcome and charlie is the worse outcome .	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)	Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %. Alpha is the best outcome and charlie worse outcome .	18 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Giomer; injectable resin composite; Resin modified glass ionomer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Giomer vs RMGI in class V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Expecting to have all the data by October 2024
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes