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Composite Repair Using Silane Coupling Agent

Clinical Performance of Repaired Resin Composite Restorations Using Separate Silane Coupling Agent Versus Adhesives Containing Regular or Acid Resistance Silane: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06392685
Enrollment
75
Registered
2024-04-30
Start date
2024-07-31
Completion date
2025-07-31
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Restoration Failure of Marginal Integrity, Hypersensitivity, Tooth Discoloration, Tooth Fracture

Keywords

Silane coupling agent, Adhesive containing silane, Acid resistance silane containing adhesive., Defective resin composite restoration, Repair of posterior resin composite

Brief 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) 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

Interventions

OTHERSilane coupling agent

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

OTHERAdhesive 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

OTHERAcid 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Marginal adaptationT0= 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.

Secondary

MeasureTime frameDescription
Anatomical formT0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.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
Marginal discolorationT0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.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.
Surface roughnessT0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.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
Secondary cariesT0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow up.Alpha :No active caries present Charlie: Active caries is present in contact with the restoration
Postoperative sensitivityT0= Baseline 24 hours postoperative. T1= 6 months follow up. T2= 12 months follow upAlpha :No postoperative sensitivity Charlie: Short-term and tolerable postoperative sensitivity

Contacts

Primary ContactYasmin Talaat, master
yasmin-abdelnabi@dentistry.cu.edu.eg01009925731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026