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

Not Applicable

• Conditions: Class V Dental Caries; High Caries Risk Patients

• Registration Number: NCT06736964
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-11-25
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical performance (Post operative hyper sensitivity)	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 Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University, Cairo, Egypt; 🇪🇬 Cairo, Egypt