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NCT Number: NCT05509127

Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive

Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.

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This study is active but is not currently recruiting participants.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Dentistry - Cairo University

Cairo, Egypt

About this study

The innovative Scotchbond Universal Plus Adhesive offers all the benefits of its predecessor, Single Bond Universal Adhesive as demonstrated by a 3M field evaluation comparing the performance of the two products. These benefits include:

  • Compatibility with all etching techniques - total-etch, self-etch, and selective enamel etch.
  • Usage with direct and indirect indications.
  • Bonding to all dental surfaces without the need for separate primers or silanes
  • Virtually no post-operative sensitivity.

The newly modified adhesive with its careful formulation offers:

  • Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment.
  • Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure.
  • Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics.
  • Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle.
  • A BPA derivative-free formulation to alleviate concerns about BPA in dental materials
  • A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications.

As with any new material or technique, long-term clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. So, the aim of this study is to evaluate the clinical performance of the modified universal adhesive, versus the conventional universal adhesive, for restoring carious class V cavities over one year and a half.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Small to moderate carious cervical lesions. (ICDAS scores 3,4)
  • Upper premolar teeth.
  • Good oral hygiene (mild to moderate plaque accumulation)
  • Vital teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and normal contact with adjacent teeth.

Exclusion criteria

  • Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates.
  • Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia.
  • Evidence of parafunctional habits and TMJ disorders.
  • Class V lesions in molars.
  • Non-carious cervical lesions.
  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Endodontically treated teeth.
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion and occlusal contacts or history of bruxism.
  • Severe periodontal affection.

Treatment and study plan

Modified universal adhesive

Drug

Application of the modified universal adhesive is done according to manufacturer's instructions using a micro-brush. It is actively rubbed for 20 seconds, gently air-dried for 5 seconds then light cured for 20 seconds.

Other names: 3M ESPE™ Scotchbond Universal Plus Adhesive

Conventional universal adhesive

Drug

Application of the conventional Single Bond Universal adhesive is done using a micro-brush followed by rubbing for 20 seconds, gentle air drying for 5 seconds then light curing for 20 seconds.

Other names: 3M ESPE™ Single Bond Universal Adhesive

Primary outcomes

  1. Change in Marginal adaptation

    Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.

    using Modified USPHS criteria

Secondary outcomes

  1. Marginal discoloration

    Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.

    using Modified USPHS criteria

  2. Post-operative sensitivity

    Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.

    using Modified USPHS criteria

  3. Retention

    Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.

    using Modified USPHS criteria

  4. Secondary caries

    Time frame: Baseline, 6 months, 12 months, 18 months and 24 months.

    using Modified USPHS criteria

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 19, 2022
Registry last updated
Oct 16, 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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