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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

496 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-25

Study Completion Date

2025-09-03

Brief Summary

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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

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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

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Dental Pulp Disease Dental Pain and Sensation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study follows a parallel assignment intervention model, where participants are randomly allocated into two groups in a 1:1 ratio. One group will receive resin-modified glass ionomer cement (RMGIC) and the other will receive conventional glass ionomer cement (GIC) for luting fixed dental prostheses. Each participant will undergo a standardized clinical procedure including tooth preparation, isolation, and cementation by trained postgraduate trainees. The intervention (type of cement) is applied once, and post-cementation sensitivity will be assessed at 24 hours and 7 days following the procedure. Randomization and stratification will be employed to reduce bias and ensure comparability between groups

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

In this study, masking will be applied to the participants and the outcomes assessor to reduce performance and detection bias. Participants will not be informed about the type of luting cement used during their treatment. The outcomes assessor, responsible for evaluating post-cementation sensitivity, will also be blinded to group allocation to ensure unbiased data collection. However, due to the clinical differences in handling the materials, the care providers and investigators cannot be masked.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

luting material applaication with Modified Glass Ionomer Cement (RMGIC)

Intervention Type PROCEDURE

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.

Conventional Glass Ionomer Cement (GIC)

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.

Group Type ACTIVE_COMPARATOR

luting material applaication with Modified Glass Ionomer Cement (RMGIC)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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luting material applaication with Glass Ionomer Cement GIC)

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes