Glass Ionomer Restorations With SMART Versus Conventional Treatment in Elderly Cancer Patients
2026년 9월 2일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: marwa ashraf husseiny, Master's candidate
- 전화번호: +201061388709
- 이메일: marwa.husseiny@dentistry.cu.edu.eg
연구 연락처 백업
- 이름: Rawda Abd ElAziz Hesham Abd ElAziz
- 이메일: rawda.hesham@dentistry.cu.edu.eg
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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).
다른 이름들:
|
|
실험적: 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).
다른 이름들:
|
|
실험적: 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).
다른 이름들:
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.
|
|
활성 비교기: 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).
다른 이름들:
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Retention of Restoration
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postoperative Hypersensitivity
기간: 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
기간: 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
기간: 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
기간: perioperatively
|
Time required to complete the restorative procedure, measured in seconds using a stopwatch (Caro et al., 2012).
|
perioperatively
|
|
Anatomic Form
기간: 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
기간: 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
기간: 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
기간: 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
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 15일
기본 완료 (추정된)
2027년 7월 15일
연구 완료 (추정된)
2028년 1월 15일
연구 등록 날짜
최초 제출
2026년 8월 29일
QC 기준을 충족하는 최초 제출
2026년 9월 2일
처음 게시됨 (실제)
2026년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 2일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- cons sdf 4-2-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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아니
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아니
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