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NCT Number: NCT06572124

Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

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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Key information

Conditions

Carious Lesion Cervical Caries Dental Caries Root Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

21 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Retention (Success rate)

    Time frame: 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

  1. Marginal adaptation

    Time frame: 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.

  2. Marginal discoloration

    Time frame: 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.

  3. Secondary caries

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed El-Kotaby, Master

CONTACT

[email protected]

Egypt +201150961970

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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