Comparison of Post Cementation Sensitivity Between Resin-Modified Glass Ionomer Cement and Conventional Glass Ionomer Cement as a Luting Material: A Randomized Clinical Trial
| Registry | NCT07102121, acronym RMGICvsGIC |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 496 (Estimated) |
| Sponsor | Saidu College of Dentistry (Other) |
| Conditions | Dental Pulp Disease, Dental Pain and Sensation Disorder |
| Interventions | luting material applaication with Modified Glass Ionomer Cement (RMGIC) (Procedure) |
| Dates | start 2025-01-25, primary completion 2025-09-03 (estimated), completion 2025-09-03 (estimated), first posted 2025-08-03, last updated 2025-09-09 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Dental Pulp Disease All trials for Dental Pain and Sensation Disorder All trials of luting material applaication with Modified Glass Ionomer Cement (RMGIC)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Modified Glass Ionomer Cement (RMGIC) | Active comparator | Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC) | 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 |
| Conventional Glass Ionomer Cement (GIC) | Active comparator | Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC) | 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. |
Sex: All, ages: 15 Years to 60 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| Dental college | Mingora, Khyber Pakhtunkhwa | Pakistan |