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Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

NCT06572124 — Not applicable, Unknown, 80 participants, Cairo University

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

RegistryNCT06572124
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment80 (Estimated)
SponsorCairo University (Other)
ConditionsCarious Lesion, Cervical Caries
Interventionsuniversal adhesive without Acid resistant silane coupling agent, universal adhesive with Acid resistant silane coupling agent (Procedure)
Datesstart 2024-09-01 (estimated), primary completion 2026-04-30 (estimated), completion 2026-04-30 (estimated), first posted 2024-08-26, last updated 2024-09-04
Locations1 site in Egypt

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Universal adhesive without acid resistant silane coupling agentActive comparatorProcedure: 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 agentExperimentalProcedure: 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
  • universal adhesive without Acid resistant silane coupling agent (Procedure): 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 agent (Procedure): 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.

+Outcome measures

Primary outcomes

  • Retention (Success rate) [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

Secondary outcomes

  • Marginal adaptation [T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.]: 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.
  • Marginal discoloration [T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.]: 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.
  • Secondary caries [T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.]: Alpha (A) No active caries present Charlie(C) Active caries is present in contact with the restoration

+Eligibility

Sex: All, ages: 21 Years to 67 Years, 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

+Locations (1)

FacilityCityCountryStatus
Cairo UniversityCairoEgypt

My Notes