Carious LesionNCT06572124
Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions
A study testing universal adhesive without Acid resistant silane coupling agent and universal adhesive with Acid resistant silane coupling agent in people with Carious Lesion and Cervical Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months. Read more about this study
- Who is it for?
- Ages 21 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Lesion, Cervical Caries
- What is being tested?
- universal adhesive without Acid resistant silane coupling agent and universal adhesive with Acid resistant silane coupling agent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Apr 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 21 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants Inclusion:
- Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion
- Teeth Inclusion:
- Vital teeth with carious cervical lesions in incisors , canines ,premolars\& molars
Who cannot join
- Participants Exclusion:
- Patients with fewer than 20 teeth
- Poor oral hygiene
- Uncontrolled periodontal disease
- Xerostomia
- Known allergy to resin-based materials
Show all 11Show fewer
- Medically compromised, pregnant, or breast-feeding
- Teeth Exclusion:
- Non vital teeth
- Teeth that are out of occlusion
- Previously restored teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Universal Adhesive with and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled Trial
Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.
Read the detailed description
The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.
- Conditions
- Carious Lesion, Cervical Caries
- Being tested
- universal adhesive without Acid resistant silane coupling agent, universal adhesive with Acid resistant silane coupling agent
- Medical subject headings
- Dental Caries, Root Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
universal adhesive without Acid resistant silane coupling agentProcedure or surgery
After cavity preparations, enamel margins will be etched for 30 seconds then rinsed and dried, then the Universal adhesive without acid resistant silane coupling agent will be actively applied for 20 seconds then air thinned for 5 seconds then cured for 20 seconds.Then the composite restoration will be placed.
universal adhesive with Acid resistant silane coupling agentProcedure or surgery
After cavity preparations, enamel margins will be etched for 30 seconds then rinsed and dried, then the Universal adhesive which contains acid resistant silane coupling agent will be actively applied for 20 seconds then air thinned for 5 seconds then cured for 20 seconds.Then the composite restoration will be placed.
| Study group | Role | What they receive |
|---|---|---|
| Universal adhesive without acid resistant silane coupling agent | Active comparator | Universal adhesive with normal silane (comparator) After the acid etching and rinsing and drying step, the universal adhesive with normal silane will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed Receives: Procedure: universal adhesive without Acid resistant silane coupling agent |
| Universal adhesive with acid resistant silane coupling agent | Experimental | Universal adhesive with acid resistant silane coupling agent (Intervention) After the acid etching and rinsing and drying step, the universal adhesive with acid resistant silane coupling agent will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed Receives: Procedure: universal adhesive with Acid resistant silane coupling agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention (Success rate)
Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent
Measured: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Secondary outcomes (3)
Marginal adaptation
Alpha (A) Restoration adapts closely to the tooth structure; there is no visible crevice.
Bravo (B) There is a visible crevice, the explorer will penetrate, without dentin exposure.
Charlie(C)The explorer penetrates into a crevice in which dentin or the base is exposed.
Measured: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Marginal discoloration
Alpha (A) No marginal discoloration. Bravo (B) Minor marginal discoloration without staining toward the pulp, only visible using a mirror and operating light.
Charlie(C) Deep discoloration with staining toward the pulp, visible at a speaking distance of 60 to 100 cm.
Measured: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Secondary caries
Alpha (A) No active caries present Charlie(C) Active caries is present in contact with the restoration
Measured: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious LesionStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Kotaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572124
- Sponsor's protocol ID
- CairoU ARS
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 4 Sep 2024
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Universal Adhesive with and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06572124
- Acronym / sponsor ID
- CairoU ARS
- Conditions
- Carious Lesion, Cervical Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 26 Aug 2024 (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.
Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.
Detailed description
The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal adhesive without acid resistant silane coupling agent | Active comparator | Procedure: universal adhesive without Acid resistant silane coupling agentUniversal adhesive with normal silane (comparator) After the acid etching and rinsing and drying step, the universal adhesive with normal silane will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed |
| Universal adhesive with acid resistant silane coupling agent | Experimental | Procedure: universal adhesive with Acid resistant silane coupling agentUniversal adhesive with acid resistant silane coupling agent (Intervention) After the acid etching and rinsing and drying step, the universal adhesive with acid resistant silane coupling agent will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed |
Who may qualify
- Ages
- 21 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants Inclusion:
- Teeth Inclusion:
Key exclusion criteria (11 listed)
- Participants Exclusion:
- Teeth Exclusion:
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 |
|---|---|---|
| universal adhesive without Acid resistant silane coupling agentAfter cavity preparations, enamel margins will be etched for 30 seconds then rinsed and dried, then the Universal adhesive without acid resistant silane coupling agent will be actively applied for 20 seconds then air thinned for 5 seconds then cured for 20 seconds.Then the composite restoration will be placed. | Procedure or surgery | Universal adhesive without acid resistant silane coupling agent |
| universal adhesive with Acid resistant silane coupling agentAfter cavity preparations, enamel margins will be etched for 30 seconds then rinsed and dried, then the Universal adhesive which contains acid resistant silane coupling agent will be actively applied for 20 seconds then air thinned for 5 seconds then cured for 20 seconds.Then the composite restoration will be placed. | Procedure or surgery | Universal adhesive with acid resistant silane coupling agent |
Primary outcome
Retention (Success rate)
Time frame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent
3 secondary outcomes
Marginal adaptation
Time frame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Marginal discoloration
Time frame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Secondary caries
Time frame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Carious Lesion
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing universal adhesive without Acid resistant silane coupling agent and universal adhesive with Acid resistant silane coupling agent in people with Carious Lesion and Cervical Caries, 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 11 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed El-Kotaby, Master (Egypt +201150961970, ahmed.elkotaby@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (Success rate) (time frame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.). 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 Sep 2024.