Clinical Performance of Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment for Elderly Cancer Patients: A 12-Month Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Retention of Restoration
研究概览
简要总结
This study will evaluate the clinical performance of glass ionomer cervical restorations placed using the Silver-Modified Atraumatic Restorative Technique (SMART) compared with conventional restorative treatment in elderly cancer patients with cervical carious lesions. The trial is a 12-month randomized clinical trial with four parallel arms and a 1:1 allocation ratio. Two SMART arms will receive 38% silver diamine fluoride (SDF) and potassium iodide followed by either high-viscosity glass ionomer cement (HVGIC) or resin-modified glass ionomer cement (RMGIC), while the conventional arms will receive standard tooth preparation followed by HVGIC or RMGIC without SDF. The primary outcome is retention of the restoration, assessed using USPHS criteria. Secondary outcomes include postoperative hypersensitivity, marginal integrity, recurrent caries, average duration of treatment, anatomic form, color match, surface roughness, marginal discoloration, and patient satisfaction (VAS). Patients will be followed at baseline, 3, 6, and 12 months. The study aims to determine whether the minimally invasive SMART approach offers comparable clinical performance to conventional treatment while reducing chair time and discomfort in a medically vulnerable elderly cancer population.
详细描述
Adult cancer patients (35-55 years) with primary cervical carious lesions will be recruited from the outpatient clinics of the Faculty of Dentistry, Cairo University. Eligible teeth must be vital by pulp sensitivity testing with controlled periodontal conditions; teeth with previous restorations, irreversible pulpitis signs, mobility, resorption, or cuspal loss will be excluded, as will patients with material allergies, fixed orthodontic appliances, pregnancy, or frequent analgesic use that could mask pain. After signing informed consent, participants will be randomized 1:1 using a computer-generated sequence (random.org) with allocation concealed via sequentially numbered, opaque, sealed envelopes. The study is double-blinded (participants and outcome assessors blinded; the treating operator is not blinded). Baseline data collection includes medical/dental history and pre-operative radiographs. Interventions will be applied by a single trained operator following standardized protocols for SDF/GIC placement (SMART arms) or conventional cavity preparation and GIC placement (control arms). Data will be collected on paper/Excel and analyzed using MedCalc software (v22) with Chi-square, Cochran's Q, one-way ANOVA/Tukey post-hoc, and repeated-measures ANOVA/Bonferroni-corrected comparisons, with significance set at p≤0.05 and 80% power. Sample size (29 teeth/group) was calculated using G*Power based on prior HVGIC retention data. The trial is self-funded, with independent auditing conducted by the co-supervisor.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-related criteria:
- •Adult cancer patients of both genders, aged 35-55 years
- •Good oral hygiene
- •Willing to sign the informed consent
- •Co-operative patients who accept the follow-up period
- •Tooth-related criteria:
- •Teeth with primary root surface caries (active dentin carious lesions, Nyvad score 2 or 3)
- •Teeth with gum recession
- •Teeth vital according to pulp sensitivity tests
- •Controlled gingival or periodontal conditions
排除标准
- •Patient-related criteria:
- •Allergy to any of the restorative materials
- •Patients undergoing orthodontic treatment with fixed appliances
- •Pregnant women
- •Patients who frequently use analgesics or any drugs that could mask pain
- •Tooth-related criteria:
- •Teeth with previous restorations
- •Spontaneous or prolonged pain (more than 15 seconds) after cold test, indicating irreversible pulpitis
- •Negative sensibility test, periapical radiolucency, or sensitivity to percussion
- •Mobile teeth indicating periodontal disease or trauma
- •External or internal resorption
- •Chipped teeth or cuspal loss
研究组 & 干预措施
SMART with High-Viscosity GIC
Application of 38% Silver Diamine Fluoride (SDF) and potassium iodide to the carious lesion, followed by restoration with High-Viscosity Glass Ionomer Cement (HVGIC, Riva Light Cure) according to tooth location, using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
干预措施: Silver Diamine Fluoride (SDF, 38%) (Other)
SMART with High-Viscosity GIC
Application of 38% Silver Diamine Fluoride (SDF) and potassium iodide to the carious lesion, followed by restoration with High-Viscosity Glass Ionomer Cement (HVGIC, Riva Light Cure) according to tooth location, using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
干预措施: High-Viscosity Glass Ionomer Cement (Other)
SMART with Resin-Modified GIC
Application of 38% Silver Diamine Fluoride (SDF) and potassium iodide to the carious lesion, followed by restoration with Resin-Modified Glass Ionomer Cement (RMGIC, Riva Self Cure), using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
干预措施: Silver Diamine Fluoride (SDF, 38%) (Other)
SMART with Resin-Modified GIC
Application of 38% Silver Diamine Fluoride (SDF) and potassium iodide to the carious lesion, followed by restoration with Resin-Modified Glass Ionomer Cement (RMGIC, Riva Self Cure), using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
干预措施: Resin-Modified Glass Ionomer Cement (Other)
Conventional with Resin-Modified GIC
Conventional mechanical tooth preparation (excavation of caries with hand instruments and rotary burs, cavity conditioning with polyacrylic acid) followed by restoration with Resin-Modified Glass Ionomer Cement (RMGIC, Riva Self Cure), without prior SDF application.
干预措施: Conventional Tooth Preparation (Procedure)
Conventional with Resin-Modified GIC
Conventional mechanical tooth preparation (excavation of caries with hand instruments and rotary burs, cavity conditioning with polyacrylic acid) followed by restoration with Resin-Modified Glass Ionomer Cement (RMGIC, Riva Self Cure), without prior SDF application.
干预措施: Resin-Modified Glass Ionomer Cement (Other)
Conventional with High-Viscosity GIC
Conventional mechanical tooth preparation (excavation of caries with hand instruments and rotary burs, cavity conditioning with polyacrylic acid) followed by restoration with High-Viscosity Glass Ionomer Cement (HVGIC, Riva Light Cure) according to tooth location, without prior SDF application.
干预措施: Conventional Tooth Preparation (Procedure)
Conventional with High-Viscosity GIC
Conventional mechanical tooth preparation (excavation of caries with hand instruments and rotary burs, cavity conditioning with polyacrylic acid) followed by restoration with High-Viscosity Glass Ionomer Cement (HVGIC, Riva Light Cure) according to tooth location, without prior SDF application.
干预措施: High-Viscosity Glass Ionomer Cement (Other)
结局指标
主要结局
Retention of Restoration
时间窗: Baseline, 3 months, 6 months, and 12 months
Evaluation of the presence and integrity of the restoration over the follow-up period, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - restoration present; Bravo (B) - partial loss, clinically acceptable; Charlie (C) - clinically unacceptable partial/total loss; Delta (D) - immediate replacement necessary.
次要结局
- Postoperative Hypersensitivity(Baseline, 3 months, 6 months, and 12 months)
- Marginal Integrity(Baseline, 3 months, 6 months, and 12 months)
- Recurrent Caries(Baseline, 3 months, 6 months, and 12 months)
- Average Duration of Treatment(perioperatively)
- Anatomic Form(Baseline, 3 months, 6 months, and 12 months)
- Color Match(Baseline, 3 months, 6 months, and 12 months)
- Surface Roughness and Marginal Discoloration(Baseline, 3 months, 6 months, and 12 months)
- Patient Satisfaction(Immediately after the intervention, and at 3, 6, and 12 months)
研究者
Marwa Ashraf Husseiny
Resident, Conservative Dentistry Department
Cairo University