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

NCT05389163 | Completed FDA Device

• 1 other identifier: Giomer vs RMGI in class V
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Class V Dental Caries

Keywords

Giomer; injectable resin composite; Resin modified glass ionomer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)

  18 months

Study Arms (2)

Giomer based injectable resin composite

EXPERIMENTAL

Beautifil Flow plus X F03, SHOFU, USA

Device: Giomer based injectable resin composite

Resin modified glass ionomer

ACTIVE COMPARATOR

Fuji II LC, GC

Device: Resin modified glass ionomer

Interventions

Giomer based injectable resin composite 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

Giomer based injectable resin composite

Resin modified glass ionomer 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.

Resin modified glass ionomer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

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

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 25, 2022
• Study Start: July 17, 2022
• Primary Completion: April 5, 2024
• Study Completion: July 4, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Expecting to have all the data by October 2024

Locations

EG (1)