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

NCT07102121 | Enrolling By Invitation

• 1 other identifier: 8643/SCD/SWAT/ethical
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Pulp Disease; Dental Pain and Sensation Disorder

Keywords

sensitivity; cementation; post cementation

Outcome Measures

Primary Outcomes (1)

• 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

  At 24 hours, one week, one month, 2 months and three months after cementation

Study Arms (2)

Modified Glass Ionomer Cement (RMGIC)

ACTIVE COMPARATOR

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)

Conventional Glass Ionomer Cement (GIC)

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: luting material applaication with Glass Ionomer Cement GIC)

Conventional Glass Ionomer Cement (GIC); Modified Glass Ionomer Cement (RMGIC)

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saidu College of Dentistry: lead

Study Sites (1)

Dental college

Mingora, Khyber Pakhtunkhwa, 19130, Pakistan

Location

MeSH Terms

Conditions

Dental Pulp Diseases; Toothache; Sensation Disorders; Hypersensitivity

Interventions

Glass Ionomer Cements

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: saiduCDentistry

Model Details: 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

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 3, 2025
• Study Start: January 25, 2025
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)