Comparison of Post Cementation Sensitivity Between RMGIC and GIC as Luting Materials in a Randomized Clinical Trial

Официальное название

Comparison of Post Cementation Sensitivity Between Resin-Modified Glass Ionomer Cement and Conventional Glass Ionomer Cement as a Luting Material: A Randomized Clinical Trial

Обзор

This randomized controlled trial aims to compare post-cementation sensitivity between resin-modified glass ionomer cement (RMGIC) and conventional glass ionomer cement (GIC) as luting materials. Conducted at the Prosthodontics Department, Saidu College of Dentistry, Swat, the study will enroll 248 patients aged 15-70 with vital abutment teeth, randomly assigned to receive either RMGIC or GIC. Sensitivity will be assessed using a 10-point Visual Analog Scale (VAS), with scores above 1 considered indicative of post-operative sensitivity and further categorized for analysis. Strict inclusion/exclusion criteria and randomization will control bias and confounders. Data will be analyzed in SPSS 22 using t-tests and chi-square tests, with significance set at p≤0.05.

Подробное описание

Dental prostheses are frequently used to replace missing teeth. Fixed partial dentures are regarded as the gold standard for restoring lost teeth, aiming to recover proper function, speech, and appearance. These fixed prostheses must be securely attached to the neighboring teeth using specific bonding agents known as luting cements. Ideal luting materials should exhibit low solubility, biocompatibility, resistance to leakage, and should not cause discomfort or sensitivity after cementation. Common luting agents include glass ionomer cement (GIC), resin-modified glass ionomer cement (RMGIC), zinc phosphate cement, and zinc oxide eugenol cement. Among these, GIC and RMGIC are considered reliable and long-lasting choices for luting purposes.

This randomized controlled trial aims to compare post-cementation sensitivity between resin-modified glass ionomer cement (RMGIC) and conventional glass ionomer cement (GIC) as luting materials. Conducted at the Prosthodontics Department, Saidu College of Dentistry, Swat, the study will enroll 248 patients aged 15-70 with vital abutment teeth, randomly assigned to receive either RMGIC or GIC. Sensitivity will be assessed using a 10-point Visual Analog Scale (VAS), with scores above 1 considered indicative of post-operative sensitivity and further categorized for analysis. Strict inclusion/exclusion criteria and randomization will control bias and confounders. Data will be analyzed in SPSS 22 using t-tests and chi-square tests, with significance set at p≤0.05.

Вмешательства

• Процедура luting material applaication with Modified Glass Ionomer Cement (RMGIC)
  The intervention involves the use of two different types of luting cements-resin-modified glass ionomer cement (RMGIC) and conventional glass ionomer cement (GIC)-for the cementation of fixed dental prostheses. The objective is to compare post-cementation sensitivity between the two materials. All clinical procedures, including tooth preparation, isolation, and cementation, will follow standardized protocols. Sensitivity will be measured using the Visual Analog Scale (VAS) at 24 hours and 7 days

Первичные конечные точки

• Dentinal sensitivity [Срок оценки: At 24 hours, one week, one month, 2 months and three months after cementation]

Критерии участия

Критерии включения

• Patients aged between 15 to 70 years

Both male and female participants

Abutment teeth with vital pulp

Sound abutment teeth with no signs of attrition, erosion, or abrasion

No history of pulp capping procedures on abutment teeth

Критерии исключения

• Patients currently undergoing orthodontic treatment or who completed it within the last 3 months

Use of bleaching or desensitizing agents

History of recent periodontal surgery

Patients on medications that affect pain perception (e.g., analgesics, carbamazepine)

Patients with psychiatric conditions that may affect pain reporting or compliance

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Dental college — Mingora

Публикации

• Alam S, Sadiq N, Elsayed HM, Shakir S, Shaheen NH, Elmarakby AM, Rehman A. Comparison of Post-Cementation Sensitivity Between Resin Modified Glass Ionomer Cement and Conventional Glass Ionomer Cement as a Luting Material-A Randomized Clinical Trial. Clin Exp Dent Res. 2026 Apr;12(2):e70339. doi: 10.1002/cre2.70339. PMID 41914436

Идентификаторы

NCT: NCT07102121 · 8643/SCD/SWAT/ethical

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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