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

2. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Annen: 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).
Andre navn:
  • Riva Light Cure
  • HVGIC
Eksperimentell: 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.
Annen: 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.
Annen: 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).
Andre navn:
  • RMGIC
  • Riva Self Cure
Eksperimentell: 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.
Annen: 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).
Andre navn:
  • RMGIC
  • Riva Self Cure
Fremgangsmåte: 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.
Aktiv 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.
Annen: 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).
Andre navn:
  • Riva Light Cure
  • HVGIC
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Retention of Restoration
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Hypersensitivity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: perioperatively
Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).
perioperatively
Anatomic Form
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. januar 2027

Primær fullføring (Antatt)

15. juli 2027

Studiet fullført (Antatt)

15. januar 2028

Datoer for studieregistrering

Først innsendt

29. august 2026

Først innsendt som oppfylte QC-kriteriene

2. september 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • cons sdf 4-2-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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