Sensitivity, ToothPhase 4GCPNCT05882760
Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth
A Phase 4 study testing Tetric N Bond Universal®, Self Etch Tetric N Bond Universal® and GC Fuji IX, GC, Japan® in people with Sensitivity, Tooth, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial summary
There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Tooth
- What is being tested?
- Tetric N Bond Universal®, Self Etch Tetric N Bond Universal® and GC Fuji IX, GC, Japan®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Either gender Minimum age 18 years, maximum age 40 years. Class I \& II Cavity on maxillary and mandibular 1st and 2nd molars. Vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth.
Who cannot join
- Irreversible Pulpitis diagnosed clinically and radiographically. Class I \& Class II cavity of premolars and third molars Patients taking analgesic prior to treatment. History of allergic reaction to any dental material used in the study. History of parafunctional habits (bruxism and/or clenching) Malocclusion
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Dentistry, Liaquat University of Medical and Health Sciences
Hyderābād, Sindh
About this study
Official title: Comparison of Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth
There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. The purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration
- Conditions
- Sensitivity, Tooth
- Being tested
- Tetric N Bond Universal®, Self Etch Tetric N Bond Universal®, GC Fuji IX, GC, Japan®, Activa TM Bioactive Restorative ®
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetric N Bond Universal®Drug
Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch \& Rinse Tetric - N - Bond (Ivoclar)
Self Etch Tetric N Bond Universal®Drug
Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal®
GC Fuji IX, GC, Japan®Drug
Cavities will be restored with GC Fuji IX, GC, Japan®
Activa TM Bioactive Restorative ®Drug
Cavities will be restored with Activa TM Bioactive Restorative ®
| Study group | Role | What they receive |
|---|---|---|
| Tetric N Bond Universal® | Experimental | Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Etch \& Rinse Technique using Tetric N Bond Universal®. Receives: Drug: Tetric N Bond Universal® |
| Self Etch Tetric N Bond Universal® | Active comparator | Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Technique using Tetric N Bond Universal®. Receives: Drug: Self Etch Tetric N Bond Universal® |
| GC Fuji IX, GC, Japan® | Active comparator | Cavities in this group will be restored with GC Fuji IX, GC, Japan® Receives: Drug: GC Fuji IX, GC, Japan® |
| Activa TM Bioactive Restorative ® | Active comparator | Cavities in this group will be restored with Activa TM Bioactive Restorative ® Receives: Drug: Activa TM Bioactive Restorative ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Sensitivity
Sensitivity will be recorded as present when a patient experienced more pain when the cold stimulus is applied on the restored tooth than on the control tooth is assessed using the modified visual analogue scale to any stimulus (occlusal function, cold/hot water, or sweets) every day by the patient until 7 days, then by the clinician on 7 days, 3 months.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitivity, ToothStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarang Suresh, Liaquat University of Medical & Health Sciences
- Investigators
- Priya Rani, BDS, Principal investigator, Liaquat University of Medical and Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882760
- Sponsor's protocol ID
- LUMHS/REC/-29
- Acronym
- GCP
- Status last verified
- Mar 2025
- First submitted
- 20 May 2023
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth
- ClinicalTrials.gov ID
- NCT05882760
- Acronym / sponsor ID
- GCP / LUMHS/REC/-29
- Conditions
- Sensitivity, Tooth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 May 2023 (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.
There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. The purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tetric N Bond Universal® | Experimental | Drug: Tetric N Bond Universal®Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Etch \& Rinse Technique using Tetric N Bond Universal®. |
| Self Etch Tetric N Bond Universal® | Active comparator | Drug: Self Etch Tetric N Bond Universal®Cavities in this group will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Technique using Tetric N Bond Universal®. |
| GC Fuji IX, GC, Japan® | Active comparator | Drug: GC Fuji IX, GC, Japan®Cavities in this group will be restored with GC Fuji IX, GC, Japan® |
| Activa TM Bioactive Restorative ® | Active comparator | Drug: Activa TM Bioactive Restorative ®Cavities in this group will be restored with Activa TM Bioactive Restorative ® |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Either gender Minimum age 18 years, maximum age 40 years. Class I \& II Cavity on maxillary and mandibular 1st and 2nd molars. Vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth.
Key exclusion criteria (1 listed)
- Irreversible Pulpitis diagnosed clinically and radiographically. Class I \& Class II cavity of premolars and third molars Patients taking analgesic prior to treatment. History of allergic reaction to any dental material used in the study. History of parafunctional habits (bruxism and/or clenching) Malocclusion
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 |
|---|---|---|
| Tetric N Bond Universal®Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Etch \& Rinse Tetric - N - Bond (Ivoclar) | Drug | Tetric N Bond Universal® |
| Self Etch Tetric N Bond Universal®Cavities will be restored with Conventional Hybrid Composite Restoration bonded with Self Etch Tetric N Bond Universal® | Drug | Self Etch Tetric N Bond Universal® |
| GC Fuji IX, GC, Japan®Cavities will be restored with GC Fuji IX, GC, Japan® | Drug | GC Fuji IX, GC, Japan® |
| Activa TM Bioactive Restorative ®Cavities will be restored with Activa TM Bioactive Restorative ® | Drug | Activa TM Bioactive Restorative ® |
Primary outcome
Post Operative Sensitivity
Time frame: 3 Months
Sensitivity will be recorded as present when a patient experienced more pain when the cold stimulus is applied on the restored tooth than on the control tooth is assessed using the modified visual analogue scale to any stimulus (occlusal function, cold/hot water, or sweets) every day by the patient until 7 days, then by the clinician on 7 days, 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Priya Rani, BDS principal investigator
Liaquat University of Medical and Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetric N Bond Universal®, Self Etch Tetric N Bond Universal® and GC Fuji IX, GC, Japan® in people with Sensitivity, Tooth, run by Liaquat University of Medical & Health Sciences 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post Operative Sensitivity (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.