Clinical PerformanceNCT05928533
Performance Of Cervical Restorations Using Nitric Acid and Mineral Enriched Adhesive Versus Phosphoric Acid and Universal Adhesive
A study testing clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apex in people with Clinical Performance, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate the clinical performance of multifunction Nitric acid etch, mineral enriched adhesive and flowable resin composite liner versus the universal adhesive in etch and rinse mode and regular flowable liner in cervical carious anterior cavities. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Clinical Performance
- What is being tested?
- clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jan 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cervical carious anterior lesions.
- Age: (18-45Ys)
- Gender: male and female
- Low and moderate caries risk patient
Who cannot join
- Patients with poor oral hygiene.
- Presence of para functional habits.
- Systemic diseases or severe medical complications.
- Lack of compliance.
- Rampant caries.
- Xerostomia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Of Cervical Restorations Using Nitric Acid and Mineral Enriched Adhesive Versus Phosphoric Acid and Universal Adhesive: Randomized Clinical Trial.
To evaluate the clinical performance of multifunction Nitric acid etch, mineral enriched adhesive and flowable resin composite liner versus the universal adhesive in etch and rinse mode and regular flowable liner in cervical carious anterior cavities.
Read the detailed description
The annual failure of composite restoration represents 1 to 5 % with anterior teeth and 1 to3 % with posterior teeth . Many challenges appeared to be the causative factors of this failure such as the technique sensitivity of its placement, polymerization shrinkage, type and design of the cavity, location of the tooth, adhesive materials used last but not least operator and patient related factors. Some of these obstacles can be controllable and others cannot. According to the systematic review published in 2022, the most common reasons for composite failure are marginal deterioration which led consequently to secondary caries, marginal discoloration and post operative sensitivity. Restoration of the cervical carious lesions represents a great challenge to the restorative dentist due to the complicated clinical situation which include difficult isolation, variation in the tooth substrates and intraoral biomechanical challenges. Lots of modifications in the resin composite material and technique of application have been done and they are still ongoing to overcome the abovementioned inherited shortcomings.
The smear layer is considered as an unstable structure that affects the chemical and mechanical bonding between the restoration and tooth structure. There are different techniques to deal with the smear layer, either to remove, modify or dissolve it. Total removal of this layer with35-37% Phosphoric was the most used technique for preparing the tooth substrate to receive resin composite restoration. However, postoperative sensitivity was a repeated complaint from the patients. Selective enamel etching technique was introduced to solve this problem by only applying the phosphoric acid on the enamel margins and the multimode adhesive incorporating mild acidic monomer will achieve the dentin conditioning mission. Later, it was concluded that the clinical performance of multimode adhesives with etch, and rinse mode was better than with self-etch mode. Furthermore, there is available commercial product introduced to deal with the tooth substrate in a different way which is the multifunction nitric acid etch. It contains acid which enable the etching ability and cauterize the minor bleeding, isopropyl alcohol which acts as an antibacterial agent and cleans the surface before bonding and Hydroxyethyl methacrylate (HEMA) is a desensitizer which block the dentinal tubules to reduce the hypersensitivity.
Another concern, which can maximize the performance of the restorative system is the implementation of the bioactive property in the restorative system. The concept of bioactivity was achieved by introducing materials which interact with the surrounding tissues and produce a specific effect in the form of biological response or release of active substances. This release encourages remineralization and improves health, longevity and tissue regeneration. The idea of bioactivity was first introduced in dentistry by Larry Hench in 1960. Furthermore, the bioactive materials have many properties like inhibition of the bacterial growth by releasing calcium, sodium, silica and phosphate ion and an osteogenic property due to the use of calcium phosphate or tricalcium phosphate . Many trials were conducted to study the influence of using the bioactive materials in the restorative dentistry as the addition of fluoride, calcium phosphate particles and bioactive glass. The first used bioactive glass in dentistry was 45S5 glass in 1988. It is considered as a rich source of minerals which plays an important role in tooth remineralization. The remineralization is considered nowadays the most effective way to compensate the loss in tooth structure . Giomer is considered one of the most common categories of the bioactive materials. It relies on the incorporation of the surface pre reacted glass ionomer particles in its composition. Another category is termed as mineral enriched restorative system which incorporates bioactive glass in its composition . Such bio constructive materials work in conjugation with the healing ability of the human body to help in reinforcement of the tooth substrate. The bioactive glass is calcium sodium phosphosilicate based material which releases calcium and phosphate, increases the pH and optimizing the conditions for remineralization. Also, it contains hydrated silica which aids in the formation of hydroxyapatite like layers on the surface of restoration preventing the penetration of bacteria and secondary caries development. By adding the bioactive material, the restorative system will be able to survive for an extended time. Unfortunately, reviewing the literature revealed absence of any clinical trials that study the performance of multifunction nitric acid etch and the mineral enriched adhesive and flowable resin composite.
- Conditions
- Clinical Performance
- Being tested
- clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apex
- Keywords
- clinical performance, cervical caries, bioactive restoration, nitric acid, universal adhesive
- Medical subject headings
- Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apexOther
the clean and boost use to clean the tooth surface after cavity preparation without causing severe form of hypersensitivity then the RE GEN universal adhesive is applied by using a brush and cured with the RE GEN flowable composite for 20 seconds. Curing both together increase the bioactivity of the material.
| Study group | Role | What they receive |
|---|---|---|
| Scotchbond Etchant gel ,Single Bond Universal adhesive , Filtek Supreme flowable composite of 3M | Active comparator | After cavity preparation, enamel and dentin will be etched for 15 seconds using Scotchbond Universal Etchant gel 3M. The surface will be rinsed for 10 seconds and dried with compressed air, removing all excess moisture without desiccating the dentin structure then apply two coats of Single Bond Universal adhesive 3M with a micro brush with rubbing action for 20 seconds then evaporate the solvent with gentle air stream until no movement is noticed in the adhesive then finally light cured for 10 seconds. A Filtek Supreme 3M flowable composite will be used to restore the prepared cavity after selecting the appropriate shade. The shade selection for the flowable composite will be done before the cavity preparation. The flowable composite will be applied in increments of 2mm thickness then light cured for 40 seconds using LED light curing unit. |
| clean and boost enamel cleanser, RE GEN universal adhesive & flowable composite of vista apex. | Experimental | After cavity preparation, clean and boost enamel cleanser of vista apex will be used to clean enamel and dentin surface by three steps: 1. With the enclosed flow-thru brush tip, apply Clean \& Boost to the surface to be cleansed, ensuring the surface is completely saturated. 2. Using the delivery brush tip, agitate the Clean \& Boost on the surface for 10 seconds. 3. Rinse thoroughly. The RE GEN universal adhesive from vista apex will be applied with micro brush with rubbing action then air agitation. RE GEN Bio active flowable composite form vista apex will be added to the universal adhesive and then cured together for 20 seconds according to the manufacture instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative sensitivity
Modified USPHS criteria United states public health service
Measured: 24hours, 6, 12 and18 months
Secondary outcomes (4)
Marginal deterioration
Modified USPHS criteria United states public health service
Measured: 24 hours,6,12 and 18 months
Marginal discoloration
Modified USPHS criteria United states public health service
Measured: 24 hours, 6, 12 and 18 months
Retention
Modified USPHS criteria United states public health service
Measured: 24 hours,6,12 and 18 months
Secondary caries
Modified USPHS criteria United states public health service
Measured: 24 hours,6,12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PerformanceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourane Yasser Ali Mohamed Yassin, Cairo University
- Investigators
- Olfat El sayed Hassanein, Professor, Study director, Olfat.hassanein@dentistry.cu.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928533
- Sponsor's protocol ID
- Nourane Yasser Ali Mohamed
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Of Cervical Restorations Using Nitric Acid and Mineral Enriched Adhesive Versus Phosphoric Acid and Universal Adhesive: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05928533
- Acronym / sponsor ID
- Nourane Yasser Ali Mohamed
- Conditions
- Clinical Performance
- Keywords
- clinical performance, cervical caries, bioactive restoration, nitric acid, universal adhesive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Jul 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.
To evaluate the clinical performance of multifunction Nitric acid etch, mineral enriched adhesive and flowable resin composite liner versus the universal adhesive in etch and rinse mode and regular flowable liner in cervical carious anterior cavities.
Detailed description
The annual failure of composite restoration represents 1 to 5 % with anterior teeth and 1 to3 % with posterior teeth . Many challenges appeared to be the causative factors of this failure such as the technique sensitivity of its placement, polymerization shrinkage, type and design of the cavity, location of the tooth, adhesive materials used last but not least operator and patient related factors. Some of these obstacles can be controllable and others cannot. According to the systematic review published in 2022, the most common reasons for composite failure are marginal deterioration which led consequently to secondary caries, marginal discoloration and post operative sensitivity. Restoration of the cervical carious lesions represents a great challenge to the restorative dentist due to the complicated clinical situation which include difficult isolation, variation in the tooth substrates and intraoral biomechanical challenges. Lots of modifications in the resin composite material and technique of application have been done and they are still ongoing to overcome the abovementioned inherited shortcomings.
The smear layer is considered as an unstable structure that affects the chemical and mechanical bonding between the restoration and tooth structure. There are different techniques to deal with the smear layer, either to remove, modify or dissolve it. Total removal of this layer with35-37% Phosphoric was the most used technique for preparing the tooth substrate to receive resin composite restoration. However, postoperative sensitivity was a repeated complaint from the patients. Selective enamel etching technique was introduced to solve this problem by only applying the phosphoric acid on the enamel margins and the multimode adhesive incorporating mild acidic monomer will achieve the dentin conditioning mission. Later, it was concluded that the clinical performance of multimode adhesives with etch, and rinse mode was better than with self-etch mode. Furthermore, there is available commercial product introduced to deal with the tooth substrate in a different way which is the multifunction nitric acid etch. It contains acid which enable the etching ability and cauterize the minor bleeding, isopropyl alcohol which acts as an antibacterial agent and cleans the surface before bonding and Hydroxyethyl methacrylate (HEMA) is a desensitizer which block the dentinal tubules to reduce the hypersensitivity.
Another concern, which can maximize the performance of the restorative system is the implementation of the bioactive property in the restorative system. The concept of bioactivity was achieved by introducing materials which interact with the surrounding tissues and produce a specific effect in the form of biological response or release of active substances. This release encourages remineralization and improves health, longevity and tissue regeneration. The idea of bioactivity was first introduced in dentistry by Larry Hench in 1960. Furthermore, the bioactive materials have many properties like inhibition of the bacterial growth by releasing calcium, sodium, silica and phosphate ion and an osteogenic property due to the use of calcium phosphate or tricalcium phosphate . Many trials were conducted to study the influence of using the bioactive materials in the restorative dentistry as the addition of fluoride, calcium phosphate particles and bioactive glass. The first used bioactive glass in dentistry was 45S5 glass in 1988. It is considered as a rich source of minerals which plays an important role in tooth remineralization. The remineralization is considered nowadays the most effective way to compensate the loss in tooth structure . Giomer is considered one of the most common categories of the bioactive materials. It relies on the incorporation of the surface pre reacted glass ionomer particles in its composition. Another category is termed as mineral enriched restorative system which incorporates bioactive glass in its composition . Such bio constructive materials work in conjugation with the healing ability of the human body to help in reinforcement of the tooth substrate. The bioactive glass is calcium sodium phosphosilicate based material which releases calcium and phosphate, increases the pH and optimizing the conditions for remineralization. Also, it contains hydrated silica which aids in the formation of hydroxyapatite like layers on the surface of restoration preventing the penetration of bacteria and secondary caries development. By adding the bioactive material, the restorative system will be able to survive for an extended time. Unfortunately, reviewing the literature revealed absence of any clinical trials that study the performance of multifunction nitric acid etch and the mineral enriched adhesive and flowable resin composite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scotchbond Etchant gel ,Single Bond Universal adhesive , Filtek Supreme flowable composite of 3M | Active comparator | –After cavity preparation, enamel and dentin will be etched for 15 seconds using Scotchbond Universal Etchant gel 3M. The surface will be rinsed for 10 seconds and dried with compressed air, removing all excess moisture without desiccating the dentin structure then apply two coats of Single Bond Universal adhesive 3M with a micro brush with rubbing action for 20 seconds then evaporate the solvent with gentle air stream until no movement is noticed in the adhesive then finally light cured for 10 seconds. A Filtek Supreme 3M flowable composite will be used to restore the prepared cavity after selecting the appropriate shade. The shade selection for the flowable composite will be done before the cavity preparation. The flowable composite will be applied in increments of 2mm thickness then light cured for 40 seconds using LED light curing unit. |
| clean and boost enamel cleanser, RE GEN universal adhesive & flowable composite of vista apex. | Experimental | –After cavity preparation, clean and boost enamel cleanser of vista apex will be used to clean enamel and dentin surface by three steps: 1. With the enclosed flow-thru brush tip, apply Clean \& Boost to the surface to be cleansed, ensuring the surface is completely saturated. 2. Using the delivery brush tip, agitate the Clean \& Boost on the surface for 10 seconds. 3. Rinse thoroughly. The RE GEN universal adhesive from vista apex will be applied with micro brush with rubbing action then air agitation. RE GEN Bio active flowable composite form vista apex will be added to the universal adhesive and then cured together for 20 seconds according to the manufacture instructions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cervical carious anterior lesions.
- Age: (18-45Ys)
- Gender: male and female
- Low and moderate caries risk patient
Key exclusion criteria (6 listed)
- Patients with poor oral hygiene.
- Presence of para functional habits.
- Systemic diseases or severe medical complications.
- Lack of compliance.
- Rampant caries.
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 |
|---|---|---|
| clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apexthe clean and boost use to clean the tooth surface after cavity preparation without causing severe form of hypersensitivity then the RE GEN universal adhesive is applied by using a brush and cured with the RE GEN flowable composite for 20 seconds. Curing both together increase the bioactivity of the material. | Other | – |
Primary outcome
Post operative sensitivity
Time frame: 24hours, 6, 12 and18 months
Modified USPHS criteria United states public health service
4 secondary outcomes
Marginal deterioration
Time frame: 24 hours,6,12 and 18 months
Marginal discoloration
Time frame: 24 hours, 6, 12 and 18 months
Retention
Time frame: 24 hours,6,12 and 18 months
Secondary caries
Time frame: 24 hours,6,12 and 18 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 4 May 2025.
- Individual participant dataSharing planned: Yes
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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.
Olfat El sayed Hassanein, Professor study director
Olfat.hassanein@dentistry.cu.edu.eg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apex in people with Clinical Performance, run by Cairo 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 4 inclusion and 6 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 4 May 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 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. 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 (time frame: 24hours, 6, 12 and18 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 4 May 2025.