HEMA-free Universal Adhesives for Restoring Non-carious Cervical Lesions

NCT05497583 | Completed

• 1 other identifier: universal adhesive
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

because of the recent introduction of universal adhesives, little information is currently available about the bond durability of universal adhesives to various substrates. Evaluation of bond durability is important since the stability of the bond between the adhesive and substrates is related to the clinical success of restorations. Because significant hydrolysis of the dentin-resin interface occurs after 6-12 months, a clinical trial of at least 18 months' duration is indicated to more accurately depict the likelihood of long-term clinical success

Conditions

Universal Adhesive

Outcome Measures

Primary Outcomes (1)

• Primary outcome (marginal staining)

  FDI (World Dental Federation)criteria

  18 months

Secondary Outcomes (1)

• Retention, marginal adaptation, Postoperative (Hyper-Sensitivity), and Recurrence of Caries

  T0=Baseline immediate postoperative T1= 6 months follow up. T2=12 months follow up. T3=18 months follow up.

Study Arms (2)

Acetone based HEMA free Universal Adhesive

EXPERIMENTAL

Patients with non-carious cervical lesions will be treated with Acetone Based HEMA-free Universal Adhesive (BeautiBond universal adhesive ) applied in a self-etch approach with (SE) selective enamel etching.

Other: Acetone based HEMA -free universal Adhesive

Isopropanol based HEMA-free universal Adhesive

ACTIVE COMPARATOR

Patients with non-carious cervical lesions will be treated with isopropanol-based HEMA-free universal Adhesive (Prime\&Bond universal™ Adhesive system) applied in a self-etch approach with (SE) selective enamel etching.

Other: Isopropanol based HEMA- free universal Adhesive

Interventions

Acetone based HEMA -free universal Adhesive OTHER

Teeth that meet the inclusion criteria will be selected. the operator will prepare incisal bevel. Rubber dam isolation will be used .apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse, for 10 s Air dry to remove excess water then will apply Universal adhesive to the entire bonding surface according to manufacture instructions. Bioactive composite ( beautifill II ) will be used.

Acetone based HEMA free Universal Adhesive

Isopropanol based HEMA- free universal Adhesive OTHER

Teeth that meet the inclusion criteria will be selected. the operator will prepare incisal bevel. Rubber dam isolation will be used .apply etchant (phosphoric acid etching gel 37 %) only on enamel for 15 s Rinse, for 10 s Air dry to remove excess water then will apply Universal adhesive to the entire bonding surface according to manufacture instructions. resin composite (Neo Spectra™ ST) will be used.

Isopropanol based HEMA-free universal Adhesive

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants had to be in good general health, be at least 18 years old
• have an acceptable oral hygiene level
• Participants were required to have NCCLs in different teeth preferably anterior or posterior that needed to be restored.
• These lesions had to be noncarious
• deeper than 1 mm
• involve both the enamel and dentin of vital teeth without mobility.

You may not qualify if:

• Uncooperative behavior, limits the use of adhesive due to hampering of adequate field or isolation techniques throughout the procedure.
• Patients allergic to the adhesive material. Patients with extremely poor oral hygiene
• severe or chronic periodontitis
• heavy bruxism habits
• Pulp involvement

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 11, 2022
• Study Start: January 15, 2023
• Primary Completion: September 20, 2024
• Study Completion: November 23, 2024
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

EG (1)