An interventional study of Silver Diamine Fluoride (SDF, 38%) and Conventional Tooth Preparation in Dental Caries and Cervical Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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 two parallel arms and a 1:1 allocation ratio. SMART arms will receive 38% silver diamine fluoride (SDF) and potassium iodide followed by high-viscosity glass ionomer cement (HVGIC) ), while the conventional arms will receive standard tooth preparation followed by HVGIC 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, 9and 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.
Adult cancer patients (45-55 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 1:1using a computer-generated sequence (random.org) with allocation concealed via sequentially numbered, opaque, sealed envelopes. The study is Single blinded ( 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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Root Caries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dental Caries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 19, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Tooth-related criteria:
Exclusion Criteria:
Tooth-related criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 self Cure) according to tooth location, using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
Other: Silver Diamine Fluoride (SDF, 38%) · Other: High-Viscosity Glass Ionomer Cement
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 self Cure) according to tooth location, without prior SDF application.
Procedure: Conventional Tooth Preparation · Other: High-Viscosity Glass Ionomer Cement
38% Silver Diamine Fluoride applied to the carious lesion using a micro brush for one minute, followed by application of potassium iodide (KI)Applied in the SMART group 1-3 times until the precipitate clears to reduce black staining, prior to restoration. Used in SMART arm only, with no mechanical removal of carious dentin.
Conventional mechanical excavation of carious dentin using sharp hand instruments and air-turbine handpiece, burs and excavators; selective caries removal , 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 restorative cement placed and cured according to tooth location, following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Also known as: HVGIC, RIVA self cure
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, 9 and 12 months
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 or transient hypersensitivity; Charlie (C) - moderate or severe hypersensitivity;
Time frame: Baseline, 3 months, 6 months, 9 and 12 months
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,9 and 12 months
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, 9,and 12 months
Average Duration of Treatment
Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).
Time frame: perioperatively
Anatomic Form
Assessment of whether the restoration correctly mimics the natural contours, height, and functional shape of the original tooth, using USPHS criteria (Zhao et al., 2018): Alpha - restoration continuous with existing anatomic form; Bravo - continuous but not exposing cement or dentin; Charlie - sufficient material lost to expose cement material or dentin.
Time frame: Baseline, 3 months, 6 months, 9 and 12 months
Color Match
Measures how well the shade of the restorative material blends with the neighboring natural tooth structure, using USPHS criteria (Zhao et al., 2018): Alpha - no mismatch; Bravo - mismatch within normal range of color, shade, and translucency; Charlie - mismatch outside normal range.
Time frame: Baseline, 3 months, 6 months, 9 and 12 months
Surface Roughness and Marginal Discoloration
Combined assessment of restoration surface smoothness and marginal staining using USPHS criteria (Zhao et al., 2018): Surface roughness scored Alpha (smooth) to Charlie (rough, cannot be refinished); marginal discoloration scored Alpha (none) to Charlie (discoloration penetrated in pulpal direction).
Time frame: Baseline, 3 months, 6 months, 9 and 12 months
Patient Satisfaction
Patient-reported satisfaction with treatment, measured using a Visual Analog Scale (VAS) from 0 (unsatisfied) to 10 (totally satisfied), where the patient marks a vertical line across the scale and the distance in millimeters from the zero end is measured (Golpak, 2020).
Time frame: Immediately after the intervention, and at 3, 6,9, and 12 months
No study locations are listed for this record.
Plan to share: No — 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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