Dental Pain and Sensation Disorder, Dental Pulp Disease
Conditions
Keywords
sensitivity, cementation, post cementation
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.
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.
Interventions
PROCEDUREluting 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.
Sponsors
Saidu College of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Pakistan
Outcome results
None listed