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

NCT07102121 — Not applicable, Enrolling by invitation, 496 participants, Saidu College of Dentistry

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

RegistryNCT07102121, acronym RMGICvsGIC
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment496 (Estimated)
SponsorSaidu College of Dentistry (Other)
ConditionsDental Pulp Disease, Dental Pain and Sensation Disorder
Interventionsluting material applaication with Modified Glass Ionomer Cement (RMGIC) (Procedure)
Datesstart 2025-01-25, primary completion 2025-09-03 (estimated), completion 2025-09-03 (estimated), first posted 2025-08-03, last updated 2025-09-09
Locations1 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)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Modified Glass Ionomer Cement (RMGIC)Active comparatorProcedure: 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 comparatorProcedure: 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.
  • luting material applaication with Modified Glass Ionomer Cement (RMGIC) (Procedure), also known as luting material applaication with Glass Ionomer Cement GIC): 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.

+Outcome measures

Primary outcomes

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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Dental collegeMingora, Khyber PakhtunkhwaPakistan

+Publications

  • Results publication: 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