Hypersensitivity DentinNCT06772051
Clinical Evaluation of Short Dentin Etching
A study testing Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching), Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching) and Resin composite restoration bonded using universal adhesive in self-etch mode in people with Hypersensitivity Dentin and Dental Restoration Failure of Marginal Integrity, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching), Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching) and Resin composite restoration bonded using universal adhesive in self-etch mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Dec 2024to 30 Dec 2026
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with three primary occlusal caries of upper or lower posterior teeth.
- Patients must have a good oral hygiene;
- Patients with tooth gives a positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Who cannot join
- High caries risk patients with extremely poor oral hygiene
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University, Egypt
Al Mansurah, Dakahliya, 35516
About this study
Official title: Short Dentin Etching With a Universal Adhesive: Two-Year Double-Blind Trial Comparing Etching Strategies and Durations
To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.
Read the detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split mouth design. A total of thirty adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on ninety Class I restorations. No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from December 2024 to December 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation. To determine the appropriate sample size, previous studies examining the clinical success rate of posterior Class I restorations restored using different adhesive strategies were considered. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 30 subjects (Three restorations per patient) was determined to be suitable.
- Being tested
- Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching), Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching), Resin composite restoration bonded using universal adhesive in self-etch mode
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)Procedure or surgery
Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)
Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)Procedure or surgery
Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)
Resin composite restoration bonded using universal adhesive in self-etch modeProcedure or surgery
Resin composite restoration bonded using universal adhesive in self-etch mode
| Study group | Role | What they receive |
|---|---|---|
| Dentin etching and rinse (15 seconds etching) | Placebo comparator | The dentin in the pulpal floor in this group will receive phosphoric acid etching for 15 seconds followed by rinsing and drying before universal adhesive application Receives: Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching) |
| Dentin etching and rinse (5 seconds etching) | Active comparator | The dentin in the pulpal floor in this group will receive phosphoric acid etching for 5 seconds followed by rinsing and drying before universal adhesive application Receives: Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching) |
| Dentin self-etch | Placebo comparator | The dentin in the pulpal floor in this group will receive universal adhesive application in self-etch mode without prior phosphoric acid etching Receives: Procedure: Resin composite restoration bonded using universal adhesive in self-etch mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypersensitivity/pulp status
The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria. This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Measured: Two years after restoration
Marginal adaptation
The marginal adaptation will be evaluated through visual examination using a 250 µm probe and brief air drying. This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Measured: Two years after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start24 Dec 2024
- Primary completion24 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity DentinStudies 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
- Crossover
- Model description
- Each patient will receive three restorations in posterior teeth randomly on three different quadrants, each tooth will be restored with one of the three tested adhesive strategies. All materials will be used according to manufacturers' instructions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hoda S Ismail, Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772051
- Sponsor's protocol ID
- A04012024 CD
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Dentin Etching With a Universal Adhesive: Two-Year Double-Blind Trial Comparing Etching Strategies and Durations
- ClinicalTrials.gov ID
- NCT06772051
- Acronym / sponsor ID
- A04012024 CD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Jan 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.
To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.
Detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split mouth design. A total of thirty adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on ninety Class I restorations. No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from December 2024 to December 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation. To determine the appropriate sample size, previous studies examining the clinical success rate of posterior Class I restorations restored using different adhesive strategies were considered. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 30 subjects (Three restorations per patient) was determined to be suitable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Each patient will receive three restorations in posterior teeth randomly on three different quadrants, each tooth will be restored with one of the three tested adhesive strategies. All materials will be used according to manufacturers' instructions
| Arm | Type | Receives |
|---|---|---|
| Dentin etching and rinse (15 seconds etching) | Placebo comparator | Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)The dentin in the pulpal floor in this group will receive phosphoric acid etching for 15 seconds followed by rinsing and drying before universal adhesive application |
| Dentin etching and rinse (5 seconds etching) | Active comparator | Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)The dentin in the pulpal floor in this group will receive phosphoric acid etching for 5 seconds followed by rinsing and drying before universal adhesive application |
| Dentin self-etch | Placebo comparator | Procedure: Resin composite restoration bonded using universal adhesive in self-etch modeThe dentin in the pulpal floor in this group will receive universal adhesive application in self-etch mode without prior phosphoric acid etching |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with three primary occlusal caries of upper or lower posterior teeth.
- Patients must have a good oral hygiene;
- Patients with tooth gives a positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Key exclusion criteria (3 listed)
- High caries risk patients with extremely poor oral hygiene
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 |
|---|---|---|
| Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching) | Procedure or surgery | Dentin etching and rinse (15 seconds etching) |
| Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching) | Procedure or surgery | Dentin etching and rinse (5 seconds etching) |
| Resin composite restoration bonded using universal adhesive in self-etch modeResin composite restoration bonded using universal adhesive in self-etch mode | Procedure or surgery | Dentin self-etch |
Primary outcome
Postoperative hypersensitivity/pulp status
Time frame: Two years after restoration
The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria. This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Marginal adaptation
Time frame: Two years after restoration
The marginal adaptation will be evaluated through visual examination using a 250 µm probe and brief air drying. This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
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 20 Oct 2026.
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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.
Hoda S Ismail, Lecturer principal investigator
Faculty of Dentistry, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching), Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching) and Resin composite restoration bonded using universal adhesive in self-etch mode in people with Hypersensitivity Dentin and Dental Restoration Failure of Marginal Integrity, run by Mansoura University at 1 site in Egypt.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 20 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Postoperative hypersensitivity/pulp status (time frame: Two years after restoration). The study lists 2 primary outcomes in all. 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 20 Oct 2026.