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Enrolling by Invitation

NCT Number: NCT06736964

Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients

The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.

Reducing the incidence of recurrent caries is the primary outcome

Enrolling by Invitation

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University, Cairo, Egypt

Cairo, Egypt

About this study

Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .

Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .

This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient age range from 25-45 year.
  • High risk caries.
  • Patients required at least a couple of Class V restorations.
  • The depth of lesion should be(1.5- 2 mm) .
  • The patient should have good general health

Exclusion criteria

  • Poor oral hygiene.
  • Sever or chronic periodontal disease or Bruxism.
  • Severe tooth sensitivity.
  • Non-vital or fracture or cracked teeth.
  • Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
  • pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study

Treatment and study plan

Giomer

Device

based on Pre-reacted glass ionomer (PRG)

Primary outcomes

  1. clinical performance (Post operative hyper sensitivity)

    Time frame: 12 months

    method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using Binary (yes/ no) yes outcome mean recurrent caries present, no mean no recurrent caries present .

Secondary outcomes

  1. clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity)

    Time frame: 18 months

    method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha ,Bravo, Charlie) as unite of measurement by scoring %.

    Alpha is best outcome and Charlie worse outcome.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 17, 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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