Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive

NCT05509127 | Active Not Recruiting Phase 1

• 1 other identifier: Modified Universal Adhesive
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clinical Performance

Keywords

Performance; Carious; Cervical; Universal adhesive; USPHS criteria

Outcome Measures

Primary Outcomes (1)

• Change in Marginal adaptation

  using Modified USPHS criteria

  Baseline, 6 months, 12 months, 18 months and 24 months.

Secondary Outcomes (4)

• Marginal discoloration

  Baseline, 6 months, 12 months, 18 months and 24 months.

• Post-operative sensitivity

  Baseline, 6 months, 12 months, 18 months and 24 months.

• Retention

  Baseline, 6 months, 12 months, 18 months and 24 months.

• Secondary caries

  Baseline, 6 months, 12 months, 18 months and 24 months.

Study Arms (2)

Carious cervical lesions treated with modified universal adhesive

EXPERIMENTAL

Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of modified universal adhesive. The cavity is then restored with nano-filled resin composite.

Drug: Modified universal adhesive

Carious cervical lesions treated with conventional universal adhesive

ACTIVE COMPARATOR

Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of conventional universal adhesive. The cavity is then restored with nano-filled resin composite.

Drug: Conventional universal adhesive

Interventions

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.

Also known as: 3M ESPE™ Scotchbond Universal Plus Adhesive

Carious cervical lesions treated with modified universal 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.

Also known as: 3M ESPE™ Single Bond Universal Adhesive

Carious cervical lesions treated with conventional universal adhesive

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Adhesives

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: January 1, 2023
• Primary Completion: August 15, 2024
• Study Completion: January 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

EG (1)