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Glass Ionomer Restorations With SMART Versus Conventional Treatment in Elderly Cancer Patients

NCT07803757 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Cervical Caries

Interventions

OTHER

Silver Diamine Fluoride (SDF, 38%)

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.

PROCEDURE

Conventional Tooth Preparation

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.

OTHER

High-Viscosity Glass Ionomer Cement

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).

OTHER

Resin-Modified Glass Ionomer Cement

Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-15
Primary Completion
2027-07-15
Completion
2028-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803757 on ClinicalTrials.gov