Class V Dental Caries, High Caries Risk Patients
Conditions
Keywords
bioactive restorative material, dual cure bulk fill bio-active restoration, Pre-reacted glass ionomer (PRG) Giomer
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.
Interventions
DEVICEGiomer
based on Pre-reacted glass ionomer (PRG)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Double ( participant, Outcome Assessor)
Intervention model description
parallel assignment
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed