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
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2027
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2026
CompletedFirst Posted
Study publicly available on registry
September 4, 2026
CompletedStudy Start
First participant enrolled
January 15, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2027
Study Completion
Last participant's last visit for all outcomes
January 15, 2028
September 4, 2026
September 1, 2026
6 months
August 29, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention of Restoration
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.
Baseline, 3 months, 6 months, and 12 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (4)
SMART with High-Viscosity GIC
EXPERIMENTALApplication 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.
SMART with Resin-Modified GIC
EXPERIMENTALApplication 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.
Conventional with Resin-Modified GIC
EXPERIMENTALConventional 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.
Conventional with High-Viscosity GIC
ACTIVE COMPARATORConventional 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.
Interventions
Conventional mechanical excavation of carious dentin using sharp hand instruments and round steel burs in a slow-speed handpiece, followed by cavity conditioning with 10% polyacrylic acid, rinsing, and drying, prior to restoration. No SDF is applied in this procedure.
38% Silver Diamine Fluoride applied to the carious lesion using a micro brush for one minute, followed by application of potassium iodide (KI) in esthetically sensitive areas to reduce black staining, prior to restoration. Used in the two SMART arms only, with no mechanical removal of carious dentin.
High-viscosity glass ionomer restorative cement placed and light-cured according to tooth location, following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident, Conservative Dentistry Department
Study Record Dates
First Submitted
August 29, 2026
First Posted
September 4, 2026
Study Start (Estimated)
January 15, 2027
Primary Completion (Estimated)
July 15, 2027
Study Completion (Estimated)
January 15, 2028
Last Updated
September 4, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
The dataset contains coded but potentially re-identifiable clinical and patient information. Per the study's confidentiality plan, data access is restricted to the principal investigator and study supervisors only, with records stored securely under password-protected, limited-access systems. No plan for sharing individual participant data with external researchers is currently in place.