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Not Yet Recruiting NCT07803757

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

Conditions: Dental Caries, Cervical Caries

Sex: All
Ages: 35 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Cairo University

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. 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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07803757). StuddyBuddy aggregates publicly available trial information.