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OpenTrials
Active, Not Recruiting

NCT Number: NCT06612021

Hema Free Versus Hema Containing Adhesives in Posterior Restorations

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Cairo university

Cairo, Manyal, 11555, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Beautibond universal adhesive

Procedure

HEMA free universal adhesive

Tetric N universal bond

Procedure

HEMA containing universal bond

Primary outcomes

  1. marginal staining of restoration

    Time frame: baseline ,6 months & 12 months

    marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin

Secondary outcomes

  1. caries recurrence

    Time frame: baseline ,6 months ,12 months

    caries recurrence using USPHS criteria Alpha: no recurrent caries Charlie: Caries recurrence

  2. marginal adaptation of restoration

    Time frame: baseline ,6 months and 12 months

    marginal 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 25, 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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