Dentin SensitivityNCT07862270
Comparison of Post-Operative Sensitivity of 5th Genaration Bonding Agent With 8th Generation Bonding Agent in Class1 Composite Restoration
A study testing 5th generation bonding agent and 8th generation bonding agent in people with Dentin Sensitivity, run by Rehman Medical Institute - RMI at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to compare post-operative sensitivity after Class I composite restorations using 5th-generation and 8th-generation bonding agents in adults aged 18 to 50 years. The main question is whether the level of sensitivity differs between the two bonding agents. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- 5th generation bonding agent and 8th generation bonding agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2026to 30 Aug 2026
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 50 years.
- Patients requiring Class 1 composite restorations.
- Patients of both genders were included.
- Patients with good oral hygiene and no periodontal disease.
- Patients with cavity depth 3mm measured on radiograph.
Who cannot join
- Patients with a history of hypersensitivity or allergy to dental materials.
- Patients with systemic conditions that affect oral health.
- Pregnant or lactating women.
- Patients who have used analgesics or anti-inflammatory drugs within the past 24 hours.
- Patients who are unable or unwilling to comply with scheduled follow up.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this randomized clinical trial is to compare post-operative sensitivity after Class I composite restorations using 5th-generation and 8th-generation bonding agents in adults aged 18 to 50 years. The main question is whether the level of sensitivity differs between the two bonding agents. Participants will be randomly assigned to receive either a 5th-generation or an 8th-generation bonding agent during their composite restoration. Sensitivity will be measured using a 0-10 Visual Analogue Scale immediately after treatment, at 24 hours, and at 7 days after treatment.
Read the detailed description
This randomized clinical trial will compare post-operative sensitivity following Class I composite restorations performed using a 5th-generation bonding agent and an 8th-generation bonding agent. The study will include adult patients aged 18 to 50 years who require a Class I composite restoration and meet the study eligibility criteria.
Eligible participants will be randomly allocated into two groups. Group A will receive a 5th-generation bonding agent using a total-etch technique. Group B will receive an 8th-generation bonding agent using a self-etch technique. Standardized Class I cavity preparations will be restored using composite resin under rubber dam isolation.
Before treatment, baseline sensitivity will be assessed using standardized cold and air stimuli. Following restoration, post-operative sensitivity will be assessed using a 0-10 Visual Analogue Scale, where 0 represents no pain and 10 represents the worst possible pain. Sensitivity scores will be recorded immediately after treatment, at 24 hours, and at 7 days after treatment.
The primary purpose of the study is to compare post-operative sensitivity between the two bonding-agent groups at the specified follow-up time points. The study findings will help determine whether the type of bonding agent used with Class I composite restorations is associated with differences in post-operative sensitivity.
- Conditions
- Dentin Sensitivity
- Being tested
- 5th generation bonding agent, 8th generation bonding agent
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5th generation bonding agentDevice
A 5th-generation total-etch adhesive system will be used for bonding composite resin in Class I restorations. The enamel and dentin will be etched with phosphoric acid according to the manufacturer's instructions, followed by application of the bonding agent. The composite restoration will then be placed according to the standardized clinical protocol. Post-operative sensitivity will be assessed using a visual analogue scale (VAS) at the specified follow-up periods.
8th generation bonding agentDevice
An 8th-generation self-etch adhesive system will be used for bonding composite resin in Class I restorations. The adhesive will be applied according to the manufacturer's instructions, followed by placement of the composite restoration using the standardized clinical protocol. Post-operative sensitivity will be assessed using a visual analogue scale (VAS) at the specified follow-up periods.
| Study group | Role | What they receive |
|---|---|---|
| 5th Generation bonding agent for composite restoration | Experimental | Not described Receives: Device: 5th generation bonding agent |
| 8th Generation bonding agent for composite restorstion | Experimental | Not described Receives: Device: 8th generation bonding agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative sensitivity assessed using Visual Analogue Scale (VAS)
Post-operative sensitivity will be measured using a 0-10 Visual Analogue Scale (VAS) following standardized cold stimulation. The VAS score will be recorded immediately after treatment, at 24 hours, and at 7 days.
Measured: Immediately after treatment, 24 hours, and 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Mar 2026
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehman Medical Institute - RMI
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momina Illiyeen, Rehman Medical Institute - RMI
- Investigators
- MOMINA ILLIYEEN, BDS, Principal investigator, Rehman College of Dentistry Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862270
- Sponsor's protocol ID
- Bonding Agent
- Status last verified
- Feb 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Study data will be kept confidential and used only for the purposes described in the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-Operative Sensitivity of 5th Genaration Bonding Agent With 8th Generation Bonding Agent in Class1 Composite Restoration
- ClinicalTrials.gov ID
- NCT07862270
- Acronym / sponsor ID
- Bonding Agent
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rehman Medical Institute - RMIUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 7 Oct 2026 (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 goal of this randomized clinical trial is to compare post-operative sensitivity after Class I composite restorations using 5th-generation and 8th-generation bonding agents in adults aged 18 to 50 years. The main question is whether the level of sensitivity differs between the two bonding agents. Participants will be randomly assigned to receive either a 5th-generation or an 8th-generation bonding agent during their composite restoration. Sensitivity will be measured using a 0-10 Visual Analogue Scale immediately after treatment, at 24 hours, and at 7 days after treatment.
Detailed description
This randomized clinical trial will compare post-operative sensitivity following Class I composite restorations performed using a 5th-generation bonding agent and an 8th-generation bonding agent. The study will include adult patients aged 18 to 50 years who require a Class I composite restoration and meet the study eligibility criteria.
Eligible participants will be randomly allocated into two groups. Group A will receive a 5th-generation bonding agent using a total-etch technique. Group B will receive an 8th-generation bonding agent using a self-etch technique. Standardized Class I cavity preparations will be restored using composite resin under rubber dam isolation.
Before treatment, baseline sensitivity will be assessed using standardized cold and air stimuli. Following restoration, post-operative sensitivity will be assessed using a 0-10 Visual Analogue Scale, where 0 represents no pain and 10 represents the worst possible pain. Sensitivity scores will be recorded immediately after treatment, at 24 hours, and at 7 days after treatment.
The primary purpose of the study is to compare post-operative sensitivity between the two bonding-agent groups at the specified follow-up time points. The study findings will help determine whether the type of bonding agent used with Class I composite restorations is associated with differences in post-operative sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5th Generation bonding agent for composite restoration | Experimental | Device: 5th generation bonding agent |
| 8th Generation bonding agent for composite restorstion | Experimental | Device: 8th generation bonding agent |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 50 years.
- Patients requiring Class 1 composite restorations.
- Patients of both genders were included.
- Patients with good oral hygiene and no periodontal disease.
- Patients with cavity depth 3mm measured on radiograph.
Key exclusion criteria (5 listed)
- Patients with a history of hypersensitivity or allergy to dental materials.
- Patients with systemic conditions that affect oral health.
- Pregnant or lactating women.
- Patients who have used analgesics or anti-inflammatory drugs within the past 24 hours.
- Patients who are unable or unwilling to comply with scheduled follow up.
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 |
|---|---|---|
| 5th generation bonding agentA 5th-generation total-etch adhesive system will be used for bonding composite resin in Class I restorations. The enamel and dentin will be etched with phosphoric acid according to the manufacturer's instructions, followed by application of the bonding agent. The composite restoration will then be placed according to the standardized clinical protocol. Post-operative sensitivity will be assessed using a visual analogue scale (VAS) at the specified follow-up periods. | Device | 5th Generation bonding agent for composite restoration |
| 8th generation bonding agentAn 8th-generation self-etch adhesive system will be used for bonding composite resin in Class I restorations. The adhesive will be applied according to the manufacturer's instructions, followed by placement of the composite restoration using the standardized clinical protocol. Post-operative sensitivity will be assessed using a visual analogue scale (VAS) at the specified follow-up periods. | Device | 8th Generation bonding agent for composite restorstion |
Primary outcome
Post-operative sensitivity assessed using Visual Analogue Scale (VAS)
Time frame: Immediately after treatment, 24 hours, and 7 days after treatment
Post-operative sensitivity will be measured using a 0-10 Visual Analogue Scale (VAS) following standardized cold stimulation. The VAS score will be recorded immediately after treatment, at 24 hours, and at 7 days.
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Study data will be kept confidential and used only for the purposes described in the study protocol.
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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.
MOMINA ILLIYEEN, BDS principal investigator
Rehman College of Dentistry Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5th generation bonding agent and 8th generation bonding agent in people with Dentin Sensitivity, run by Rehman Medical Institute - RMI 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: finished, as of the sponsor's last update on 7 Oct 2026. 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?
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 assessed using Visual Analogue Scale (VAS) (time frame: Immediately after treatment, 24 hours, and 7 days after treatment). 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 7 Oct 2026.