Glass Ionomer Restorations With SMART Versus Conventional Treatment in Elderly Cancer Patients
2 września 2026 zaktualizowane przez: Marwa Ashraf Husseiny, Cairo University
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
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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Szczegółowy opis
Adult cancer patients (35-55 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 1:1 using a computer-generated sequence (random.org)
with allocation concealed via sequentially numbered, opaque, sealed envelopes.
The study is double-blinded (participants and 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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
40
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: marwa ashraf husseiny, Master's candidate
- Numer telefonu: +201061388709
- E-mail: marwa.husseiny@dentistry.cu.edu.eg
Kopia zapasowa kontaktu do badania
- Nazwa: Rawda Abd ElAziz Hesham Abd ElAziz
- E-mail: rawda.hesham@dentistry.cu.edu.eg
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: SMART with High-Viscosity GIC
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 Light Cure) according to tooth location, using the Silver-Modified Atraumatic Restorative Technique (SMART), without mechanical caries removal.
|
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).
Inne nazwy:
|
|
Eksperymentalny: SMART with Resin-Modified GIC
Application 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.
|
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.
Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Inne nazwy:
|
|
Eksperymentalny: Conventional with Resin-Modified GIC
Conventional 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.
|
Resin-modified glass ionomer restorative cement placed following either SDF application (SMART arm) or conventional mechanical tooth preparation (control arm).
Inne nazwy:
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.
|
|
Aktywny komparator: Conventional with High-Viscosity GIC
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 Light Cure) according to tooth location, without prior SDF application.
|
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).
Inne nazwy:
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Retention of Restoration
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Hypersensitivity
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
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.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Marginal Integrity
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
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.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Recurrent Caries
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
Detection of caries adjacent to restoration margins, assessed using USPHS criteria (Zhao et al., 2018): Alpha (A) - caries absent; Charlie (C) - caries present.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Average Duration of Treatment
Ramy czasowe: perioperatively
|
Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).
|
perioperatively
|
|
Anatomic Form
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
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.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Color Match
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
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.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Surface Roughness and Marginal Discoloration
Ramy czasowe: Baseline, 3 months, 6 months, and 12 months
|
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).
|
Baseline, 3 months, 6 months, and 12 months
|
|
Patient Satisfaction
Ramy czasowe: Immediately after the intervention, and at 3, 6, and 12 months
|
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).
|
Immediately after the intervention, and at 3, 6, and 12 months
|
Współpracownicy i badacze
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
15 stycznia 2027
Zakończenie podstawowe (Szacowany)
15 lipca 2027
Ukończenie studiów (Szacowany)
15 stycznia 2028
Daty rejestracji na studia
Pierwszy przesłany
29 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
2 września 2026
Pierwszy wysłany (Rzeczywisty)
4 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- cons sdf 4-2-1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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