Evaluation of Glass Ionomer With Advanced Glass Hybrid Technology Versus Resin Modified Glass Ionomer in Adult Patients With Carious Cervical Lesions After One Year

NCT ID: NCT05617703

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this [type of study: Randomized clinical trial] to compare the clinical performance of using glass ionomer with advanced glass hybrid technology (AGH) in cervical carious lesion, versus Resin modified glass ionomer (RMGI) using esthetic and mechanical properties according to FDI criteria over one year.

in adult patients with cervical carious lesion.

The main question it aims to answer are:

• Will the use of glass ionomer with advanced glass hybrid technology, achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass ,or Resin Modified Glass Ionomer have better mechanical and estheic properties over one year in adult patients with cervical carious lesions ?

Participants 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 that will be received after class V cavity preparations for carious cervical lesions.

Patients will be given local anaesthesia (Mepecaine - L Cartridges) as required, and the teeth will be isolated. A No. #330 bur (MANI, INC, Japan) in a high-speed hand piece with air/water coolant will be used to prepare class V cavity. Sharp excavators of suitable size were used to excavate soft carious lesions in dentin. the prepared cavity will be isolated with rubber dam.

The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received advanced glass hybrid glass ionomer . Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year. The restorations will be clinically examined according to FDI criteria criteria in terms of esthetic and mechanical properties . The information that will be obtained will be collected and statistically analyzed.

Detailed Description

Eligibility criteria

The participants were chosen according to the following eligibility criteria:

Inclusion criteria Exclusion criteria

Patient inclusion:

1. Patients aging ≥18 years.

2. Patients with High caries risk.

3. Patients with untreated cervical caries lesion that need restorative treatment.

4. Males or females

5. No abnormal occlusion for selected teeth.

6. Patients with good likelihood of recall availability

Tooth inclusion:

1. Permanent teeth.

2. Absence of mobility.

3. Primary carious lesions.

4. Vital with positive reaction to thermal stimulus .

Patient exclusion:

1. Participants with general/systemic illness.

2. Concomitant participation in another research study.

3. Inability to comply with study procedures.

4. Heavy bruxism habits.

5. Last experience with allergic reactions against any components of the used materials.

6. Patients receiving orthodontic treatment.

7. Teeth supporting removable prosthesis

8. Patients with cervical caries lesions that need crown restoration.

9. Xerostomia.

Tooth exclusion:

1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.

2. Non-vital teeth.

3. Periapical Abscess or Fistula.

• Outcomes:

For each recall examination, two independent evaluators will perform the direct clinical evaluation at baseline, after 6 and 12 months using written criteria based on FDI criteria.

Conditions

Dental Caries Class v

Study Design

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

Study Groups

Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)

Glass Hybrid restorative systems in the clinical point of view are self-cure bulk fill materials laminated with a nano-filled, self-adhesive resin coat.

Nowadays, a new glass hybrid innovation called Advanced Glass Hybrid technology was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using prefractive indexes.

Group Type: EXPERIMENTAL

Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)

Intervention Type: DRUG

Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes

Resin Modified Glass Ionomer (Fugi II LC, GC, Japan).

Group Type: ACTIVE_COMPARATOR

Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)

Intervention Type: DRUG

Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes

Interventions

Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan)

Advanced Glass Hybrid technology (AGH) was achieved through introduction of ultra-fine highly reactive glass and high-molecular weight polyacrylic acid powders within conventional glass using particles and fillers with close refractive indexes

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient inclusion:

1. Patients aging ≥18 years.

2. Patients with High caries risk.

3. Patients with untreated cervical caries lesion that need restorative treatment.

4. Males or females

5. No abnormal occlusion for selected teeth.

6. Patients with good likelihood of recall availability

Tooth inclusion:

1. Permanent teeth.

2. Absence of mobility.

3. Primary carious lesions.

4. Vital with positive reaction to thermal stimulus .

Exclusion Criteria

• 1. Participants with general/systemic illness. 2. Concomitant participation in another research study. 3. Inability to comply with study procedures. 4. Heavy bruxism habits. 5. Last experience with allergic reactions against any components of the used materials.

6. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia.

Tooth exclusion:

1. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.

2. Non-vital teeth.

3. Periapcal Abscess or Fistula.

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Magdy Zayed

masters degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

zayed

Role: CONTACT

aya_magdy@dentistry.cu.edu.eg

00201012561397

Other Identifiers

14422018462089

Identifier Type: -

Identifier Source: org_study_id