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

N/AEnrolling By InvitationNCT06736964

Cairo University30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Class V Dental Caries High Caries Risk Patients

Interventions

GiomerDEVICE

based on Pre-reacted glass ionomer (PRG)

Eligibility

Sex: ALLMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry Cairo University, Cairo, Egypt

Cairo, Egypt

Outcomes

Primary Outcomes

clinical performance (Post operative hyper sensitivity)

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 .

Time frame: 12 months

Secondary Outcomes

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

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.

Time frame: 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.