Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

NCT ID: NCT06572124

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Carious Lesion Cervical Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Universal adhesive without acid resistant silane coupling agent

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

Group Type ACTIVE_COMPARATOR

universal adhesive without Acid resistant silane coupling agent

Intervention Type 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

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

Group Type EXPERIMENTAL

universal adhesive with Acid resistant silane coupling agent

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed El-Kotaby

Prinicipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed El-Kotaby, Master

Role: CONTACT

Egypt +201150961970

Other Identifiers

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CairoU ARS

Identifier Type: -

Identifier Source: org_study_id

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