Tooth DiscolorationNCT06392685
Composite Repair Using Silane Coupling Agent
A study testing Silane coupling agent, Adhesive containing silane.(Intervention 1 ) and Acid resistance silane containing adhesive.(Intervention 2) in people with Tooth Discoloration and Hypersensitivity, run by Cairo University.
Trial summary
Evaluation the influence of the use of silane coupling agent application as a separate step versus application of silane or acid resistance silane containing adhesives on the clinical performance of repaired posterior resin composite restorations according to Modified United States Public Health Service (USPHS)… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration, Hypersensitivity, Tooth Fracture
- What is being tested?
- Silane coupling agent, Adhesive containing silane.(Intervention 1 ) and Acid resistance silane containing adhesive.(Intervention 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants Inclusion:
- Patients aging (18-45). Patients with a high level of oral hygiene. Patients with good likelihood of recall availability. - Teeth Inclusion: The restorations were first placed 12 to 24 months ago. Teeth with healthy remaining tooth structure. Posterior restorations with approximately 3mm in size occlusal marginal defect. Asymptomatic teeth before repair.
Who cannot join
- Participants Exclusion:
- Patient with high caries risk Patient with poor periodontal health. Heavy bruxism habits. Pregnant or lactating females.
- -Teeth Exclusion: The restorations with large defects The restorations in the third molars Last experience with allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Performance of Repaired Resin Composite Restorations Using Separate Silane Coupling Agent Versus Adhesives Containing Regular or Acid Resistance Silane: A Randomized Controlled Trial
Evaluation the influence of the use of silane coupling agent application as a separate step versus application of silane or acid resistance silane containing adhesives on the clinical performance of repaired posterior resin composite restorations according to Modified United States Public Health Service (USPHS) criteria over one year.
Read the detailed description
some manufacturers have produced silane-containing adhesives in their new products, which might eliminate the need to apply separate silane. However, this silane coupling agent can be hydrolyzed by the acidic monomer in the adhesive making it useless. Acid resistance silane containing adhesive is the update version of the silane containing adhesive which provides a long lasting effective bond between the old and new resin composite restorations
- Conditions
- Tooth Discoloration, Hypersensitivity, Tooth Fracture, Dental Restoration Failure of Marginal Integrity
- Being tested
- Silane coupling agent, Adhesive containing silane.(Intervention 1 ), Acid resistance silane containing adhesive.(Intervention 2)
- Keywords
- Silane coupling agent, Adhesive containing silane, Acid resistance silane containing adhesive., Defective resin composite restoration, Repair of posterior resin composite
- Medical subject headings
- Tooth Discoloration, Hypersensitivity, Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silane coupling agentOther
Silane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done
Adhesive containing silane.(Intervention 1 )Other
Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material
Acid resistance silane containing adhesive.(Intervention 2)Other
Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done
| Study group | Role | What they receive |
|---|---|---|
| Silane coupling agent(Comparator) | Active comparator | In the control group, Silane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done. Receives: Other: Silane coupling agent |
| .Adhesive containing silane.(Intervention 1 ) | Active comparator | Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material Receives: Other: Adhesive containing silane.(Intervention 1 ) |
| Acid resistance silane containing adhesive.(Intervention 2) | Active comparator | Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done Receives: Other: Acid resistance silane containing adhesive.(Intervention 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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= 6 months follow up. T2= 12 months follow up.
Secondary outcomes (5)
Anatomical form
Alpha (A)Anatomic form ideal Bravo (B)Restoration is under contoured, without dentin, or base exposure Charlie (C)Restoration is under contoured, with dentin or base exposure; anatomic form is unsatisfactory; restoration needs replacement
Measured: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
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= 6 months follow up. T2= 12 months follow up.
Surface roughness
Alpha(A) As smooth as the surrounding enamel. Bravo(B) Rougher than surrounding enamel; improvement by finishing is feasible Charlie(C) Very rough, could become anti-esthetic and/or retain biofilm; improvement by finishing is not feasible
Measured: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Secondary caries
Alpha :No active caries present Charlie: Active caries is present in contact with the restoration
Measured: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Postoperative sensitivity
Alpha :No postoperative sensitivity Charlie: Short-term and tolerable postoperative sensitivity
Measured: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Fathy Talaat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392685
- Sponsor's protocol ID
- Composite repair
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Repaired Resin Composite Restorations Using Separate Silane Coupling Agent Versus Adhesives Containing Regular or Acid Resistance Silane: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06392685
- Acronym / sponsor ID
- Composite repair
- Conditions
- Tooth Discoloration, Hypersensitivity, Tooth Fracture, Dental Restoration Failure of Marginal Integrity
- Keywords
- Silane coupling agent, Adhesive containing silane, Acid resistance silane containing adhesive., Defective resin composite restoration, Repair of posterior resin composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 30 Apr 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 the influence of the use of silane coupling agent application as a separate step versus application of silane or acid resistance silane containing adhesives on the clinical performance of repaired posterior resin composite restorations according to Modified United States Public Health Service (USPHS) criteria over one year.
Detailed description
some manufacturers have produced silane-containing adhesives in their new products, which might eliminate the need to apply separate silane. However, this silane coupling agent can be hydrolyzed by the acidic monomer in the adhesive making it useless. Acid resistance silane containing adhesive is the update version of the silane containing adhesive which provides a long lasting effective bond between the old and new resin composite restorations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silane coupling agent(Comparator) | Active comparator | Other: Silane coupling agentIn the control group, Silane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done. |
| .Adhesive containing silane.(Intervention 1 ) | Active comparator | Other: Adhesive containing silane.(Intervention 1 )Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material |
| Acid resistance silane containing adhesive.(Intervention 2) | Active comparator | Other: Acid resistance silane containing adhesive.(Intervention 2)Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants Inclusion:
- Patients aging (18-45). Patients with a high level of oral hygiene. Patients with good likelihood of recall availability. - Teeth Inclusion: The restorations were first placed 12 to 24 months ago. Teeth with healthy remaining tooth structure. Posterior restorations with approximately 3mm in size occlusal marginal defect. Asymptomatic teeth before repair.
Key exclusion criteria (4 listed)
- Participants Exclusion:
- Patient with high caries risk Patient with poor periodontal health. Heavy bruxism habits. Pregnant or lactating females.
- -Teeth Exclusion: The restorations with large defects The restorations in the third molars Last experience with allergic reactions against any components of the used materials.
- Patients receiving orthodontic treatment
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 |
|---|---|---|
| Silane coupling agentSilane coupling agent (Porcelain primer) will be applied following the acid etch rinsing and drying step, for 30 seconds and then it will be thoroughly dried using air syringe then universal adhesive with regular silane will be actively applied for 20 seconds and then it will be light cured for 20 seconds and final restoration will be done | Other | Silane coupling agent(Comparator) |
| Adhesive containing silane.(Intervention 1 )Universal adhesive with regular silane will be applied for 20 seconds, air thinned for 10 seconds and then it will be light cured for 20 seconds and final restoration will be done using same resin composite material | Other | .Adhesive containing silane.(Intervention 1 ) |
| Acid resistance silane containing adhesive.(Intervention 2)Acid resistance silane containing adhesive will be applied for 20 seconds, dry with gentle air for 3 seconds, then with stronger air and light cured for 10 seconds and final restoration will be done | Other | Acid resistance silane containing adhesive.(Intervention 2) |
Primary outcome
Marginal adaptation
Time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
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.
5 secondary outcomes
Anatomical form
Time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Marginal discoloration
Time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Surface roughness
Time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Secondary caries
Time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.
Postoperative sensitivity
Time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Silane coupling agent, Adhesive containing silane.(Intervention 1 ) and Acid resistance silane containing adhesive.(Intervention 2) in people with Tooth Discoloration and Hypersensitivity, run by Cairo University.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yasmin Talaat, master (01009925731, yasmin-abdelnabi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (time frame: T0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.). 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 30 Apr 2024.