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

ConditionsDental CariesCervical Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-55
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silver Diamine Fluoride (SDF, 38%)

    Other intervention

    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.

  • Conventional Tooth Preparation

    Procedure/Surgery

    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.

  • High-Viscosity Glass Ionomer Cement

    Other intervention

    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 Cement

    Other intervention

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

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: SMART with High-Viscosity GICExperimental treatment 2 interventions
Group B: SMART with Resin-Modified GICExperimental treatment 2 interventions
Group C: Conventional with Resin-Modified GICExperimental treatment 2 interventions
Group D: Conventional with High-Viscosity GICActive comparator 2 interventions

Trial outcomes

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.

Time frame
Baseline, 3 months, 6 months, and 12 months

Secondary outcomes

1

Postoperative Hypersensitivity

Assessment of patient-reported sensitivity following restoration placement, evaluated using USPHS criteria (Zhao et al., 2018): Alpha (A) - no hypersensitivity; Bravo (B) - mild hypersensitivity; Charlie (C) - moderate hypersensitivity; Delta (D) - severe hypersensitivity.

Time frame
Baseline, 3 months, 6 months, and 12 months
2

Marginal Integrity

Description: Evaluation of the continuity and adaptation at the restoration margins, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - continuity at the margin; Bravo (B) - slight discontinuity at the margin; Charlie (C) - marginal defects requiring replacement.

Time frame
Baseline, 3 months, 6 months, and 12 months
3

Recurrent Caries

Detection of caries adjacent to restoration margins, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - caries absent; Charlie (C) - caries present.

Time frame
Baseline, 3 months, 6 months, and 12 months
4

Average Duration of Treatment

Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).

Time frame
perioperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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