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Enrolling by invitationNCT07102121RMGICvsGICUpdated Sep 9, 2025

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

An interventional study of luting material applaication with Modified Glass Ionomer Cement (RMGIC) in Dental Pulp Disease and Dental Pain and Sensation Disorder, sponsored by Saidu College of Dentistry. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Saidu College of Dentistry · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
496
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Pulp Disease
  • Dental Pain and Sensation Disorder

Keywords

  • sensitivity
  • cementation
  • post cementation
03

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts 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

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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
496 participants (estimated)

Study arms

  • Active comparator
    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

    Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC)

  • Active comparator
    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.

    Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC)

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.

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

05

What researchers measure

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

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

06

Study locations

1 site
  • Dental college
    Mingora, Khyber Pakhtunkhwa 19130, Pakistan
07

References and documents

Publications

  • 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. PubMed 41914436 ↗

Individual participant data

Plan to share: No — For ethical issue

08

Registry details

Key details

Study ID
NCT07102121
Lead sponsor
Saidu College of Dentistry
Responsible party
Dr Ajmal Khan (saiduCDentistry, Saidu College of Dentistry) — Principal investigator
First posted
Aug 3, 2025
Start date
Jan 25, 2025
Primary completion
Sep 3, 2025 (estimated)
Completion
Sep 3, 2025 (estimated)
Last update
Sep 9, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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