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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- FDI criteria
研究概览
简要总结
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.
详细描述
Eligibility criteria
The participants were chosen according to the following eligibility criteria:
Inclusion criteria Exclusion criteria
Patient inclusion:
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient inclusion:
- •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
- •Tooth inclusion:
- •Permanent teeth.
- •Absence of mobility.
- •Primary carious lesions.
- •Vital with positive reaction to thermal stimulus .
排除标准
- •Participants with general/systemic illness.
- •Concomitant participation in another research study.
- •Inability to comply with study procedures.
- •Heavy bruxism habits.
- •Last experience with allergic reactions against any components of the used materials.
- •Patients receiving orthodontic treatment.
- •Teeth supporting removable prosthesis
- •Patients with cervical caries lesions that need crown restoration.
- •Xerostomia.
- •Tooth exclusion:
- •Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- •Non-vital teeth.
- •Periapcal Abscess or Fistula.
研究组 & 干预措施
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.
干预措施: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) (Drug)
Resin Modified Glass Ionomer (Fugi II LC, GC, Japan).
干预措施: Glass Ionomer with Advanced Glass Hybrid Technology (Equia forte HT fil, GC, Japan) (Drug)
结局指标
主要结局
FDI criteria
时间窗: one year
Esthetic and mechanical evaluation
次要结局
未报告次要终点
研究者
Aya Magdy Zayed
masters degree student
Cairo University