Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

Cairo University (CU)

Status: Not yet enrolling

Conditions: Cervical Caries; Carious Lesion

Treatments: Procedure: universal adhesive with Acid resistant silane coupling agent; Procedure: universal adhesive without Acid resistant silane coupling agent

Study type: Interventional

Funder types: Other

Identifiers

NCT06572124

CairoU ARS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 21 to 67 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Participants Exclusion:

  • Patients with fewer than 20 teeth
  • Poor oral hygiene
  • Uncontrolled periodontal disease
  • Xerostomia
  • Known allergy to resin-based materials
  • Medically compromised, pregnant, or breast-feeding

• Teeth Exclusion:

  • Non vital teeth
  • Teeth that are out of occlusion
  • Previously restored teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Universal adhesive without acid resistant silane coupling agent

Active Comparator group

Description:

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

Treatment:

Procedure: universal adhesive without Acid resistant silane coupling agent

Universal adhesive with acid resistant silane coupling agent

Experimental group

Description:

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

Treatment:

Procedure: universal adhesive with Acid resistant silane coupling agent