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

NCT06736964 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: Ahmed abdul monsif
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 .

  12 months

Secondary Outcomes (1)

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

  18 months

Study Arms (3)

Predicta

EXPERIMENTAL

based on dual cure bulk fill bioactive restoration

Device: Giomer

Activa presto

EXPERIMENTAL

based on Bio-glass reinforced glass Ionomer

Device: Giomer

Giomer

ACTIVE COMPARATOR

based on Pre-reacted glass ionomer (PRG)

Device: Giomer

Interventions

Giomer DEVICE

based on Pre-reacted glass ionomer (PRG)

Activa presto; Giomer; Predicta

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University, Cairo, Egypt

Cairo, Egypt

Location

Study Officials

• Ashraf Nasr, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double ( participant, Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Conservative Dentistry Department

Model Details: parallel assignment

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 17, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)