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

Saidu College of Dentistry

Status: Invitation-only

Conditions: Dental Pulp Disease; Dental Pain and Sensation Disorder

Treatments: Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07102121

8643/SCD/SWAT/ethical

Details and patient eligibility

About

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.

Full 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.

Enrollment: 496 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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496 participants in 2 patient groups

Modified Glass Ionomer Cement (RMGIC)

Active Comparator group

Description:

Participants in this group will receive fixed prostheses cemented with resin-modified glass ionomer cement (RMGIC) according to manufacturer's instructions. Tooth preparation will be carried out by postgraduate trainees, and cementation will include light curing of RMGIC for 10 seconds using an LED light. Sensitivity will be assessed at 24 hours, one week, 1 month, 2 months and 3 months post-cementation

Treatment:

Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC)

Conventional Glass Ionomer Cement (GIC)

Active Comparator group

Description:

Participants in this group will receive fixed prostheses cemented with conventional glass ionomer cement (GIC). Tooth preparation and cementation will be performed by the same protocol as the other arm, except no light curing will be involved. Sensitivity levels will be recorded at 24 hours, one week , one month, two months and three months after cementation.

Treatment:

Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC)