Clinical trial NCT06736964: Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients
Official title: Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Class V Dental Caries
High Caries Risk Patients
Keywords: bioactive restorative material
dual cure bulk fill bio-active restoration
Pre-reacted glass ionomer (PRG) Giomer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical performance (Post operative hyper sensitivity)
timeFrame: 12 months
Secondary outcomes:
measure: clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity)
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University, Cairo, Egypt
Study officials:
affiliation: Cairo University
name: Ashraf Nasr, professor
role: STUDY_DIRECTOR
References: