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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05389163

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Class V Dental Caries	Drug: Giomer based injectable resin composite Drug: Resin modified glass ionomer	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Giomer based injectable resin composite Beautifil Flow plus X F03, SHOFU, USA	Drug: 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	Drug: 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.

Arm

Intervention/Treatment

Experimental: Giomer based injectable resin composite

Beautifil Flow plus X F03, SHOFU, USA

Drug: 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

Drug: 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.

Outcome Measures

Primary Outcome Measures

Clinical performance (Marginal adaptation) [24 month]
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 .

Secondary Outcome Measures

Clinical performance (Anatomical form, marginal discoloration, Secondary caries, Color match , Postoperative sensitivity, Retention,) [24 month]
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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reham Adel Yahia Hendam, assistant lecturer at conservative department,,faculty of dentistry, modern university for Technology and Information., Cairo University

ClinicalTrials.gov Identifier:

NCT05389163

Other Study ID Numbers:

Giomer vs RMGI in class V

First Posted:

May 25, 2022

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Reham Adel Yahia Hendam, assistant lecturer at conservative department,,faculty of dentistry, modern university for Technology and Information., Cairo University

Giomer

injectable resin composite

Resin modified glass ionomer

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Jun 15, 2022