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

NCT05617703 | Unknown

• 1 other identifier: 14422018462089
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries Class v

Outcome Measures

Primary Outcomes (1)

• FDI criteria

  Esthetic and mechanical evaluation

  one year

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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

Interventions

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

Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan); Resin Modified Glass Ionomer (Fugi II LC, GC, Japan).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aging ≥18 years.
• Patients with High caries risk.
• Patients with untreated cervical caries lesion that need restorative treatment.
• Males or females
• No abnormal occlusion for selected teeth.
• Patients with good likelihood of recall availability
• Permanent teeth.
• Absence of mobility.
• Primary carious lesions.
• Vital with positive reaction to thermal stimulus .

You may not qualify if:

• \. 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.
• \. Patients receiving orthodontic treatment. 7. Teeth supporting removable prosthesis 8. Patients with cervical caries lesions that need crown restoration. 9. Xerostomia.
• Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
• Non-vital teeth.
• Periapcal Abscess or Fistula.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

glass ionomer

Central Study Contacts

zayed

CONTACT

00201012561397; aya_magdy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double blinded study. The participants will not be informed to which group they will be assigned. The operator will be blinded because the restorative procedures for both groups are the same, the outcome assessors will not be informed about the type of restoration they evaluate.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: masters degree student

Model Details: Participants will be randomly divided into two groups with a 1:1 allocation using computer generated randomization list (www.random.org).

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE