Comparison of Post Cementation Sensitiv… | Clinical Trial

Key information

Conditions

Dental Pulp Disease Dental Pain and Sensation Disorder Dental Pulp Diseases Facial Pain Hypersensitivity Immune System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental college

Mingora, Khyber Pakhtunkhwa, 19130, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

luting material applaication with Modified Glass Ionomer Cement (RMGIC)

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.

Other names: luting material applaication with Glass Ionomer Cement GIC)

Primary outcomes

Dentinal sensitivity

Time frame: 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

Sponsors and collaborators

Lead sponsor

Saidu College of Dentistry

Other

Registry information

Official study title

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

Acronym: RMGICvsGIC

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 3, 2025
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed