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Hema Free Versus Hema Containing Adhesives in Posterior Restorations

Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06612021
Enrollment
64
Registered
2024-09-25
Start date
2023-07-14
Completion date
2024-11-01
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

HEMA free, HEMA containing adhesive, Giomers, Giomer, USPHS criteria

Brief summary

The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.

Detailed description

The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV. The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence. Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.

Interventions

PROCEDUREBeautibond universal adhesive

HEMA free universal adhesive

PROCEDURETetric N universal bond

HEMA containing universal bond

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

of participants: * Patients with occlusal caries in molars classified as ICDAS III or IV. * 19-35 years. * Males or Females. * Co-operative patients approving to participate in the trial.

Exclusion criteria

of participants: * Pregnancy. * Disabilities. * Systemic disease or severe medical complications. * Allergic history concerning methacrylate. * Rampant caries. * Heavy smoking. * Xerostomia. * Lack of compliance. * Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Design outcomes

Primary

MeasureTime frameDescription
marginal staining of restorationbaseline ,6 months & 12 monthsmarginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin

Secondary

MeasureTime frameDescription
caries recurrencebaseline ,6 months ,12 monthscaries recurrence using USPHS criteria Alpha: no recurrent caries Charlie: Caries recurrence
marginal adaptation of restorationbaseline ,6 months and 12 monthsmarginal adaptation using USPHS criteria ALPHA: Marginal continuity BRAVO: slightly detectable marginal discontinuity that does not require replacement CHARLIE: Detectable crevice or ledge at margin that requires replacement

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026