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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05617703
Enrollment
22
Registered
2022-11-15
Start date
2022-12-31
Completion date
2023-12-31
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries Class v

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.

Interventions

DRUGGlass 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
FDI criteriaone yearEsthetic and mechanical evaluation

Contacts

Primary Contactzayed
aya_magdy@dentistry.cu.edu.eg00201012561397

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026