NCT07102121

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 496 (estimated)
• Sponsor: Saidu College of Dentistry · Academic / Other
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Pulp Disease
• Dental Pain and Sensation Disorder

Interventions

Type	Name	Description
PROCEDURE	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 post-procedure. The study will maintain consistency across both groups, with the only variable being the type of cement used.

Timeline

• Start date: 2025-01-25
• Primary completion: 2025-09-03
• Completion: 2025-09-03
• First posted: 2025-08-03
• Last updated: 2025-09-09

Locations

1 site across 1 country: Pakistan