Clinical trial · Interventional
Glass Ionomer Restorations With SMART Versus Conventional Treatment in Elderly Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Caries | — | UNRESOLVED | — |
| Dental Caries | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Tooth Preparation | Procedure | — | UNRESOLVED |
| High-Viscosity Glass Ionomer Cement | Other | — | UNRESOLVED |
| Resin-Modified Glass Ionomer Cement | Other | — | UNRESOLVED |
| Silver Diamine Fluoride (SDF, 38%) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- SMART with High-Viscosity GIC
- description
- 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.
- interventionNames
- Other: Silver Diamine Fluoride (SDF, 38%)
- Other: High-Viscosity Glass Ionomer Cement
- type
- EXPERIMENTAL
- label
- SMART with Resin-Modified GIC
- description
- 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.
- interventionNames
- Other: Silver Diamine Fluoride (SDF, 38%)
- Other: Resin-Modified Glass Ionomer Cement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
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