An interventional study of luting material applaication with Modified Glass Ionomer Cement (RMGIC) in Dental Pulp Disease and Dental Pain and Sensation Disorder, sponsored by Saidu College of Dentistry. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Saidu College of Dentistry · Not applicable, Interventional, and Treatment
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.
130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.
This study's planned enrollment of 496 is above the median of 52 across 108 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →Saidu College of Dentistry is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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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:
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
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
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.
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.
Also known as: luting material applaication with Glass Ionomer Cement GIC)
Dentinal sensitivity
Patient-reported sensitivity will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain/sensitivity and 10 indicates the worst possible pain/sensitivity. A VAS score greater than 1 will be considered as post-cementation sensitivity. The scores will also be categorized as: No sensitivity: VAS 0-1 Mild: VAS 2-3 Moderate: VAS 4-7 Severe: VAS 8-10
Time frame: At 24 hours, one week, one month, 2 months and three months after cementation
Plan to share: No — For ethical issue
Started Jan 2025 (actual). Primary completion is estimated for Sep 2025, 7 months after the start.
Of 60 non-industry interventional studies with no phase under Dental Pulp Diseases, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 7 months is below that.
Counting every sponsor, half of 60 studies reached it within 18 months; a quarter within 9 and three quarters within 34.
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Saidu College of Dentistry