Post-operative SensitivityPhase 2/3NCT07188142
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
A Phase 2/3 study testing Drug/Agent: Gluma Desensitizer in people with Post-operative Sensitivity and Dentin Hypersensitivity, run by Beenish Hassan at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -Patients visiting OPD will be selected after fulfilment of inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post-operative Sensitivity, Dentin Hypersensitivity, Dental Caries
- What is being tested?
- Drug/Agent: Gluma Desensitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to 1 Jun 2026
- Phase
- Phase 2/3
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-45 years.
- Good oral hygiene.
- Active primary class I carious lesions on vital molar teeth with ICDAS score 3
- Patients complaining of sensitivity to air and osmotic stimulus.
- Teeth having a positive cold test.
- No signs of pulp inflammation or spontaneous pain before treatment.
Who cannot join
- Excessive tooth wear due to clenching or abnormal habits.
- Traumatic occlusion.
- Periodontal or gingival disease.
- Patients using analgesics and/or anti-inflammatory medicine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Margalla Institute of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz Housing Scheme, Rawalpindi
Rawalpindi, Punjab Province
Dr. Beenish Hassan, +92 333 9502970, beenishhassan2000@gmail.com
Dr. Beenish Hassan
About this study
Official title: Investigating the Effects of Two Different Desensitizing Agents on Mitigating Post-Operative Sensitivity Following Composite Restorations - a Randomized Controlled Trial
- The aim of this study is to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -Patients visiting OPD will be selected after fulfilment of inclusion criteria. Patients aged 18-45 meeting inclusion criteria and presenting with active primary class I carious lesions on vital molar teeth with ICDAS score 3 will be randomly assigned into two groups: -Group A: Patients will be provided with Gluma desensitizer, Universal Bonding agent and Composite restoration and -Group B: Patients will receive Universal bonding agent and Composite restoration. -The progress of treatment will be followed up immediately (baseline) and at regular follow up visits at 1 week, 1 month and 3 months.
- Post-operative sensitivity will be assessed using an air stimulus and rated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10.
Read the detailed description
-This randomized clinical trial is done to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -The study sample size includes a total of 60 participants aged 18 to 45, each having two Class I carious lesions requiring composite restorations. -Patients will be randomly divided into two groups using a lottery method: -Group A receiving Gluma desensitizer, universal bonding agent, and composite restoration, and -Group B receiving universal bonding agent and composite restoration without desensitizer. -Patients will be selected from the outpatient dental clinic after fulfilling inclusion criteria, which include age between 18 and 45 years, good oral hygiene, active primary Class I carious lesions on vital molar teeth with an ICDAS score of 3, complaints of sensitivity to air and osmotic stimulus, positive response to cold test, and no signs of pulp inflammation or spontaneous pain before treatment. -Exclusion criteria include excessive tooth wear due to clenching or abnormal habits, traumatic occlusion, periodontal or gingival disease, and current use of analgesics and/or anti-inflammatory medication. -Post-operative sensitivity will be measured clinically using an air stimulus and evaluated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10. ranging from 0 (no sensitivity) to 10 (unbearable sensitivity) at baseline (immediately after treatment) and at 1 week, 1 month, and 3 months postoperatively. -Statistical analysis will be performed using non-parametric tests including the Friedman test for within-group comparisons and Wilcoxon signed-rank test for between-group differences, with significance set at p < 0.05. -This study will further add to the literature by providing clinical evidence regarding the efficacy of Gluma desensitizer in reducing post-operative sensitivity and improving patient comfort following restorative dental procedures.
- Conditions
- Post-operative Sensitivity, Dentin Hypersensitivity, Dental Caries, Tooth Sensitivity After Composite Restorations, Post-operative Sensitivity After Class I Composite Restorations
- Being tested
- Drug/Agent: Gluma Desensitizer, Drug/Agent: No desensitizer (Control)
- Keywords
- Post-operative sensitivity, Dentinal hypersensitivity, Class I caries, Gluma desensitizer, Composite restoration
- Medical subject headings
- Dentin Sensitivity, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug/Agent: Gluma DesensitizerDrug
Also called Gluma, Glutaraldehyde/HEMA solution, Dentin desensitizer
Gluma desensitizer applied to prepared tooth surface, followed by universal bonding agent and composite restoration. Application done during the first visit of restorative treatment. Post-operative sensitivity measured at baseline, 1 week, 1 month, and 3 months.
Drug/Agent: No desensitizer (Control)Drug
Also called Control group, Composite restoration without desensitizer
Universal bonding agent applied followed by composite restoration without prior use of Gluma desensitizer. Post-operative sensitivity measured at baseline, 1 week, 1 month, and 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Group A (Gluma Desensitizer Group) | Active comparator | Patients receiving Gluma desensitizer followed by universal bonding agent and composite restoration on Class I carious lesions. Receives: Drug: Drug/Agent: Gluma Desensitizer |
| Active Comparator: Group B (Control Group) | Active comparator | Patients receiving universal bonding agent and composite restoration without Gluma desensitizer on Class I carious lesions. Receives: Drug: Drug/Agent: No desensitizer (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity
Change in dentinal hypersensitivity following Class I composite restorations, measured using a numeric rating scale to evaluate Post-operative Sensitivity (0-10) (0: No sensitivity, 10: Unbearable sensitivity) in response to air stimulus at baseline, 1 week, 1 month and 3 months post-treatment.
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 posted23 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative SensitivityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beenish Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beenish Hassan, Margalla Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188142
- Sponsor's protocol ID
- DB/272/25
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Two Different Desensitizing Agents on Mitigating Post-Operative Sensitivity Following Composite Restorations - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07188142
- Acronym / sponsor ID
- DB/272/25
- Conditions
- Post-operative Sensitivity, Dentin Hypersensitivity, Dental Caries, Tooth Sensitivity After Composite Restorations, Post-operative Sensitivity After Class I Composite Restorations
- Keywords
- Post-operative sensitivity, Dentinal hypersensitivity, Class I caries, Gluma desensitizer, Composite restoration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beenish HassanUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Sep 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.
- The aim of this study is to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -Patients visiting OPD will be selected after fulfilment of inclusion criteria. Patients aged 18-45 meeting inclusion criteria and presenting with active primary class I carious lesions on vital molar teeth with ICDAS score 3 will be randomly assigned into two groups: -Group A: Patients will be provided with Gluma desensitizer, Universal Bonding agent and Composite restoration and -Group B: Patients will receive Universal bonding agent and Composite restoration. -The progress of treatment will be followed up immediately (baseline) and at regular follow up visits at 1 week, 1 month and 3 months.
- Post-operative sensitivity will be assessed using an air stimulus and rated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10.
Detailed description
-This randomized clinical trial is done to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -The study sample size includes a total of 60 participants aged 18 to 45, each having two Class I carious lesions requiring composite restorations. -Patients will be randomly divided into two groups using a lottery method: -Group A receiving Gluma desensitizer, universal bonding agent, and composite restoration, and -Group B receiving universal bonding agent and composite restoration without desensitizer. -Patients will be selected from the outpatient dental clinic after fulfilling inclusion criteria, which include age between 18 and 45 years, good oral hygiene, active primary Class I carious lesions on vital molar teeth with an ICDAS score of 3, complaints of sensitivity to air and osmotic stimulus, positive response to cold test, and no signs of pulp inflammation or spontaneous pain before treatment. -Exclusion criteria include excessive tooth wear due to clenching or abnormal habits, traumatic occlusion, periodontal or gingival disease, and current use of analgesics and/or anti-inflammatory medication. -Post-operative sensitivity will be measured clinically using an air stimulus and evaluated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10. ranging from 0 (no sensitivity) to 10 (unbearable sensitivity) at baseline (immediately after treatment) and at 1 week, 1 month, and 3 months postoperatively. -Statistical analysis will be performed using non-parametric tests including the Friedman test for within-group comparisons and Wilcoxon signed-rank test for between-group differences, with significance set at p < 0.05. -This study will further add to the literature by providing clinical evidence regarding the efficacy of Gluma desensitizer in reducing post-operative sensitivity and improving patient comfort following restorative dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Group A (Gluma Desensitizer Group) | Active comparator | Drug: Drug/Agent: Gluma DesensitizerPatients receiving Gluma desensitizer followed by universal bonding agent and composite restoration on Class I carious lesions. |
| Active Comparator: Group B (Control Group) | Active comparator | Drug: Drug/Agent: No desensitizer (Control)Patients receiving universal bonding agent and composite restoration without Gluma desensitizer on Class I carious lesions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18-45 years.
- Good oral hygiene.
- Active primary class I carious lesions on vital molar teeth with ICDAS score 3
- Patients complaining of sensitivity to air and osmotic stimulus.
- Teeth having a positive cold test.
Key exclusion criteria (4 listed)
- Excessive tooth wear due to clenching or abnormal habits.
- Traumatic occlusion.
- Periodontal or gingival disease.
- Patients using analgesics and/or anti-inflammatory medicine.
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 |
|---|---|---|
| Drug/Agent: Gluma DesensitizerAlso: Gluma, Glutaraldehyde/HEMA solution, Dentin desensitizerGluma desensitizer applied to prepared tooth surface, followed by universal bonding agent and composite restoration. Application done during the first visit of restorative treatment. Post-operative sensitivity measured at baseline, 1 week, 1 month, and 3 months. | Drug | Active Comparator: Group A (Gluma Desensitizer Group) |
| Drug/Agent: No desensitizer (Control)Also: Control group, Composite restoration without desensitizerUniversal bonding agent applied followed by composite restoration without prior use of Gluma desensitizer. Post-operative sensitivity measured at baseline, 1 week, 1 month, and 3 months. | Drug | Active Comparator: Group B (Control Group) |
Primary outcome
Post-operative sensitivity
Time frame: 3 months
Change in dentinal hypersensitivity following Class I composite restorations, measured using a numeric rating scale to evaluate Post-operative Sensitivity (0-10) (0: No sensitivity, 10: Unbearable sensitivity) in response to air stimulus at baseline, 1 week, 1 month and 3 months post-treatment.
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 23 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Drug/Agent: Gluma Desensitizer in people with Post-operative Sensitivity and Dentin Hypersensitivity, run by Beenish Hassan 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dr. Beenish Hassan (+92 333 9502970, beenishhassan2000@gmail.com), or a site near the patient. 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 23 Sep 2025.