Dental Pulp DiseaseRMGICvsGICNCT07102121
Comparison of Post Cementation Sensitivity Between RMGIC and GIC as Luting Materials in a Randomized Clinical Trial
A study testing luting material applaication with Modified Glass Ionomer Cement (RMGIC) in people with Dental Pulp Disease and Dental Pain and Sensation Disorder, run by Saidu College of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Disease, Dental Pain and Sensation Disorder
- What is being tested?
- luting material applaication with Modified Glass Ionomer Cement (RMGIC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jan 2025to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- luting material applaication with Modified Glass Ionomer Cement (RMGIC)
- Keywords
- sensitivity, cementation, post cementation
- Medical subject headings
- Dental Pulp Diseases, Toothache, Sensation Disorders, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luting material applaication with Modified Glass Ionomer Cement (RMGIC)Procedure or surgery
Also called luting material applaication with Glass Ionomer Cement GIC)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 24 hours, one week, one month, 2 months and three months after cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start25 Jan 2025
- Primary completion3 Sep 2025 (estimated)
- Study completion3 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saidu College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ajmal Khan, Saidu College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102121
- Sponsor's protocol ID
- 8643/SCD/SWAT/ethical
- Acronym
- RMGICvsGIC
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For ethical issue
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07102121
- Acronym / sponsor ID
- RMGICvsGIC / 8643/SCD/SWAT/ethical
- Keywords
- sensitivity, cementation, post cementation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Saidu College of DentistryUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 3 Sep 2025 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Modified Glass Ionomer Cement (RMGIC) | Active comparator | Procedure: luting material applaication with 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 |
| Conventional Glass Ionomer Cement (GIC) | Active comparator | Procedure: luting material applaication with Modified Glass Ionomer Cement (RMGIC)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. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| luting material applaication with Modified Glass Ionomer Cement (RMGIC)Also: luting material applaication with Glass Ionomer Cement GIC)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. | Procedure or surgery | Conventional Glass Ionomer Cement (GIC), Modified Glass Ionomer Cement (RMGIC) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 41914436Alam 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.
- Individual participant dataSharing planned: No. For ethical issue
Related trials for Dental Pulp Disease
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
Clinical Evaluation of Two Post Systems for Single Crown Restoration of Anterior Teeth
Cairo University, Nonvital Tooth
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing luting material applaication with Modified Glass Ionomer Cement (RMGIC) in people with Dental Pulp Disease and Dental Pain and Sensation Disorder, run by Saidu College of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentinal sensitivity (time frame: At 24 hours, one week, one month, 2 months and three months after cementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07102121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.