Dental CariesNCT07803757
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
A study testing Silver Diamine Fluoride (SDF, 38%), Conventional Tooth Preparation and High-Viscosity Glass Ionomer Cement in people with Dental Caries and Cervical Caries, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Dental Caries, Cervical Caries
- What is being tested?
- Silver Diamine Fluoride (SDF, 38%), Conventional Tooth Preparation and High-Viscosity Glass Ionomer Cement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 15 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient-related criteria:
- Adult cancer patients of both genders, aged 45-55 years
- Good oral hygiene
- Willing to sign the informed consent
- Co-operative patients who accept the follow-up period
- Tooth-related criteria:
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- Posterior teeth with primary cervical surface caries, ICDAS score: 4-6
- Normal gingival or periodontal conditions.
- Teeth vital according to pulp sensitivity tests
Who cannot join
- 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:
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Rawda Abd ElAziz Hesham Abd ElAziz contact
About this study
Official title: Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical 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 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.
Read the detailed description
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.
- Conditions
- Dental Caries, Cervical Caries
- Being tested
- Silver Diamine Fluoride (SDF, 38%), Conventional Tooth Preparation, High-Viscosity Glass Ionomer Cement
- Keywords
- Silver Diamine Fluoride, SMART Technique, Glass Ionomer Cement, Atraumatic Restorative Treatment, Elderly, Cancer Patients, Cervical Restoration
- Medical subject headings
- Dental Caries, Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine Fluoride (SDF, 38%)Other
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 Tooth PreparationProcedure or surgery
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 CementOther
Also called HVGIC, RIVA self cure
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).
| Study group | Role | What they receive |
|---|---|---|
| SMART with High-Viscosity GIC | Experimental | 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. Receives: Other: Silver Diamine Fluoride (SDF, 38%); Other: High-Viscosity Glass Ionomer Cement |
| Conventional with High-Viscosity GIC | Active comparator | 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. Receives: Procedure: Conventional Tooth Preparation; Other: High-Viscosity Glass Ionomer Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 9 and 12 months
Secondary outcomes (8)
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;
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Immediately after the intervention, and at 3, 6,9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two parallel arms with 1:1 allocation: SMART arm (SDF+KI followed by HVGIC ) and conventional arm(tooth preparation followed by HVGIC , no SDF).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ashraf Husseiny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803757
- Sponsor's protocol ID
- cons 4-2-1
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.