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Not yet recruiting NCT06572124

Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

No phase Interventional Carious Lesion Cervical Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: universal adhesive without Acid resistant silane coupling agent, universal adhesive with Acid resistant silane coupling agent.
Who it may be relevant to
Registry conditions: Carious Lesion, Cervical Caries. Basic parameters: 21 years — 67 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical Performance of Universal Adhesive with and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure universal adhesive without Acid resistant silane coupling agent
    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.
  • Procedure universal adhesive with Acid resistant silane coupling agent
    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.

Primary outcome measures

  • Retention (Success rate) [Time frame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.]
Secondary outcome measures (3)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT06572124 · CairoU ARS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗