Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Giomer.
- Who it may be relevant to
- Registry conditions: Class V Dental Caries, High Caries Risk Patients. Basic parameters: 25 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial
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
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
- Device Giomer
based on Pre-reacted glass ionomer (PRG)
Primary outcome measures
- clinical performance (Post operative hyper sensitivity) [Time frame: 12 months]
Secondary outcome measures (1)
- clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity) [Time frame: 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry Cairo University, Cairo, Egypt — Cairo
Identifiers
NCT: NCT06736964 · Ahmed abdul monsif